Instruction Manual for HOLOGIC models including: Aptima SARS-CoV-2 Assay Panther System
Fusion System Operator’s Manual. B. The Aptima SARS-CoV-2 assay has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by ...
Aptima SARS -CoV-2 - Panther System 1 AW-21492 -001 Rev. 007 Aptima SARS-CoV-2 . For Emergency Authorization Use (EUA) only For in vitro diagnostic use only . Rx Only . CONTENTS General Information
Aptima® SARS-CoV-2
Aptima® SARS-CoV-2 Assay (Panther® System)
For Emergency Authorization Use (EUA) only For in vitro diagnostic use only Rx Only
CONTENTS
General Information ........................................................................................................................ 2 Intended Use ................................................................................................................................. 2 Summary and Explanation of the Test.......................................................................................... 2 Principles of the Procedure........................................................................................................... 3 Warnings and Precautions............................................................................................................ 4 Reagent Storage and Handling Requirements............................................................................ 6 Specimen Collection and Storage................................................................................................ 7 Specimen Processing ................................................................................................................... 8 Specimen Transport.................................................................................................................... 12 Specimen Pooling - Determining Appropriate Strategy for Implementation and Monitoring . 12 Preparing Samples for Pooling .................................................................................................. 12
Panther System ............................................................................................................................. 15 Reagents and Materials Provided .............................................................................................. 15 Materials Required and Available Separately............................................................................ 16 Panther System Test Procedure................................................................................................. 17 Procedural Notes......................................................................................................................... 20
Quality Control .............................................................................................................................. 22 Interpretation of Results .............................................................................................................. 22 Limitations ..................................................................................................................................... 23 Conditions of Authorization for Labs ........................................................................................ 24 Aptima Assay Performance......................................................................................................... 26 Bibliography .................................................................................................................................. 35 Appendix A: Specim en Pooling Implem entation and Monitoring Guidelines ..................... 36
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General Information
Aptima® SARS-CoV-2
General Information
Intended Use
The Aptima® SARS-CoV-2 assay is a nucleic acid amplification in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal (NP) and oropharyngeal (OP) swab specimens, nasopharyngeal washes/aspirates or nasal aspirates (collected by a healthcare provider) and anterior nasal (nasal) and mid-turbinate nasal swab specimens (collected under observation of or by a healthcare provider) from individuals who meet COVID-19 clinical and/or epidemiological criteria, as well as NP and OP swab specimens (collected by a healthcare provider) and nasal and mid-turbinate nasal swab specimens (collected under observation of or by a healthcare provider) from any individual, including from individuals without symptoms or other reasons to suspect COVID-19. The Aptima SARS-CoV-2 assay is f or use only under Emergency Use Authorization (EUA) in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
This test is also for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples containing up to 5 individual NP or OP swabs (collected by a healthcare provider), or nasal or mid-turbinate nasal swabs (collected under observation of or by a healthcare provider) where each specimen is collected using individual vials containing transport media. Negative results f rom pooled testing should not be treated as def initive. If a patient's clinical signs and symptoms are inconsistent with a negative result or if results are necessary f or patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive or invalid result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing. For specific patients, whose specimen(s) were the subject of pooling, a notice that pooling was used during testing must be included when reporting the result to the clinician or healthcare provider.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of inf ection. Positive results are indicative of the presence of SARS-CoV-2 RNA, clinical correlation with patient history and other diagnostic inf ormation is necessary to determine patient inf ection status. Positive results do not rule out bacterial inf ection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Aptima SARS-CoV-2 assay on the Panther® and Panther Fusion® systems is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the operation of the Panther and Panther Fusion systems and in vitro diagnostic procedures. The Aptima SARS- CoV-2 assay is only f or use under the Food and Drug Administration's Emergency Use Authorization.
Summary and Explanation of the Test Coronaviruses are a large family of viruses which may cause illness in animals or humans. In
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General Information
humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The most recently discovered coronavirus, SARS-CoV-2, causes the associated coronavirus disease COVID-19. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019.1
The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may have aches and pains, nasal congestion, runny nose, sore throat, new loss of taste or smell, or diarrhea. These symptoms are usually mild and begin gradually. Some people become infected but don't develop any symptoms and don't feel unwell. The disease can spread through respiratory droplets produced when an inf ected person coughs or sneezes. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. 2 These droplets also can land on objects and surfaces around the person.3 Other people may acquire SARS-CoV-2 by touching these objects or surfaces, then touching their eyes, nose, or mouth.
The virus that causes COVID-19 is infecting people and spreading easily from person to person. On March 11, 2020, the COVID-19 outbreak was characterized as a pandemic by the World Health Organization (WHO).4,5 Principles of the Procedure
The Aptima SARS-CoV-2 assay combines the technologies of target capture, Transcription Mediated Amplification (TMA), and Dual Kinetic Assay (DKA).
Specimens are collected and transferred into their respective specimen transport tubes. The transport solutions in these tubes release the RNA target and protect them from degradation during storage. When the Aptima SARS-CoV-2 assay is perf ormed in the laboratory, the target RNA molecules are isolated f rom specimens by use of capture oligomers via target capture that utilizes magnetic microparticles. The capture oligomers contain sequences complementary to specific regions of the target molecules as well as a string of deoxyadenosine residues. A separate capture oligomer is used f or each target. During the hybridization step, the sequence specific regions of the capture oligomers bind to specific regions of the target molecules. The capture oligomer:target complex is then captured out of solution by decreasing the temperature of the reaction to room temperature. This temperature reduction allows hybridization to occur between the deoxyadenosine region on the capture oligomer and the poly-deoxythymidine molecules that are covalently attached to the magnetic particles. The microparticles, including the captured target molecules bound to them, are pulled to the side of the reaction vessel using magnets and the supernatant is aspirated. The particles are washed to remove residual specimen matrix that may contain amplification reaction inhibitors. After the target capture steps are completed, the specimens are ready for amplification.
Target amplif ication assays are based on the ability of complementary oligonucleotide primers to specifically anneal and allow enzymatic amplification of the target nucleic acid strands. The Aptima SARS-CoV-2 assay replicates specific regions of the RNA from SARS-CoV-2 virus. Detection of the RNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. Single-stranded chemiluminescent nucleic acid probes, which are unique and complementary to a region of each target amplicon and Internal Control (IC) amplicon, are labeled with dif f erent acridinium ester (AE) molecules. The AE labeled probes combine with amplicon to form stable hybrids. The Selection Reagent differentiates hybridized from unhybridized probe, eliminating the generation of signal f rom unhybridized probe. During the detection step, light emitted from the labeled hybrids is measured as photon signals in a luminometer, and are reported as Relative Light Units (RLU). In DKA, differences in the kinetic profiles of the labeled probes allow for the differentiation of signal; kinetic profiles are derived
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f rom measurements of photon output during the detection read time. The chemiluminescent detection reaction for the IC signal has very rapid kinetics and has the "flasher" kinetic type. The chemiluminescent detection reaction f or the SARS-CoV-2 signal is relatively slower and has the "glower" kinetic type. Assay results are determined by a cut-of f based on the total RLU and the kinetic curve type.
The Aptima SARS-CoV-2 assay amplif ies and detects two conserved regions of the ORF1ab gene in the same reaction, using the same "glower" kinetic type. The two regions are not dif f erentiated and amplif ication of either or both regions leads to RLU signal. The assay results are determined by a cut-of f based on the total RLU and the kinetic curve type.
Warnings and Precautions
A. For in vitro diagnostic use. For use under an Emergency Use Authorization (EUA) only. For prescription use only. Carefully read this entire package insert and the Panther/Panther Fusion System Operator's Manual.
B. The Aptima SARS-CoV-2 assay has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.
C. The emergency use of the Aptima SARS-CoV-2 assay is only authorized f or the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics f or detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
D. The Aptima SARS-CoV-2 assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
E. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
F. Only personnel adequately trained on the use of this assay and in handling potentially inf ectious materials should perf orm these procedures. If a spill occurs, immediately disinf ect using appropriate site procedures.
G. Handle all specimens as if inf ectious using saf e laboratory procedures. Refer to Interim Laboratory Biosaf ety Guidelines f or Handling and Processing Specimens Associated with 2019-nCoV. https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosaf ety-guidelines.html.
H. Specimens may be infectious. Use Universal Precautions when performing this assay. Proper handling and disposal methods should be established by the laboratory director. Only personnel adequately trained in handling infectious materials should be permitted to perform this diagnostic procedure.6
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Warnings andPrecautions
I. If inf ection with SARS-CoV-2 is suspected based on current clinical screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions.
J. Use only supplied or specified disposable laboratory ware.
K. Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of being inf ected with SARS-CoV-2 as outlined in CDC Interim Laboratory Biosaf ety Guidelines f or Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV).
L. Wear disposable, powderless gloves, protective eye wear, and laboratory coats when handling specimens and reagents. Wash hands thoroughly after handling specimens and reagents.
M. Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.
N. Expiration dates listed on the Panther Fusion Specimen Lysis Tubes, Hologic Specimen Lysis Tubes, the Aptima Multitest Collection Kit, the Aptima Unisex Swab Specimen Collection Kit and the Aptima Specimen Transfer Kit pertain to the transfer of sample into the tube and not to testing of the sample. Specimens collected/transferred any time prior to these expiration dates are valid f or testing provided they are transported and stored in accordance with the appropriate package insert, even if these expiration dates have passed.
O. Maintain proper storage conditions during specimen shipping to ensure the integrity of the specimen. Specimen stability under shipping conditions other than those recommended has not been evaluated.
P. Avoid cross-contamination during the specimen handling steps. Specimens can contain extremely high levels of virus or other organisms. Ensure that specimen containers do not come in contact with one another, and discard used materials without passing them over any open containers. Change gloves if they come in contact with specimens.
Q. Do not use the reagents and controls after the expiration date.
R. Store assay components at the recommended storage condition. See Reagent Storage and Handling Requirements (page 6), and Panther System Test Procedure (page 17) for more inf ormation.
S. Do not combine any assay reagents or fluids. Do not top off reagents or fluids; the Panther system verifies reagent levels.
T. Avoid microbial and ribonuclease contamination of reagents.
U. Quality control requirements must be performed in conformance with local, state, and/or federal regulations or accreditation requirements and your laboratory's standard quality control procedures.
V. Do not use material that may contain Guanidinium thiocyanate or any guanidine-containing materials on the instrument. Highly reactive and/or toxic compounds may form if combined with sodium hypochlorite.
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W. Contamination may occur if carryover of samples is not adequately controlled during sample pool preparation, handling, and processing.
X. Testing of pooled specimens may impact the detection capability of the Aptima SARS-CoV-2 Assay and decrease sensitivity.
Y. A reagent in this kit is labeled with risk and safety symbols.
Note: For information on any hazard and precautionary statements that may be associated with reagents, refer to the Safety Data Sheet Library at www.hologicsds.com.
Selection Reagent
BORIC ACID 1-5% WARNING H315 - Causes skin irritation P264 - Wash face, hands and any exposed skin thoroughly after handling P280 - Wear protective gloves/protective clothing/eye protection/face protection P302 + P352 - IF ON SKIN: Wash with plenty of soap and water P332 + P313 - If skin irritation occurs: Get medical advice/attention P362 - Take off contaminated clothing and wash before reuse
Reagent Storage and Handling Requirements A. The following reagents are stable when stored at 2°C to 8°C (refrigerated): Aptima SARS-CoV-2 Amplification Reagent Aptima SARS-CoV-2 Enzyme Reagent Aptima SARS-CoV-2 Probe Reagent Aptima SARS-CoV-2 Internal Control Aptima SARS-CoV-2 Positive Control Aptima SARS-CoV-2 Negative Control
B. The following reagents are stable when stored at 2°C to 30°C: Aptima SARS-CoV-2 Amplif ication Reconstitution Solution Aptima SARS-CoV-2 Enzyme Reconstitution Solution Aptima SARS-CoV-2 Probe Reconstitution Solution Aptima SARS-CoV-2 Selection Reagent
C. The following reagents are stable when stored at 15°C to 30°C (room temperature): Aptima SARS-CoV-2 Target Capture Reagent Aptima Wash Solution Aptima Buffer for Deactivation Fluid Aptima Oil Reagent
D. Working Target Capture Reagent (wTCR) is stable for 30 days when stored at 15°C to 30°C. Do not refrigerate.
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E. Af ter reconstitution, the Enzyme Reagent, Amplif ication Reagent, and Probe Reagent are stable for 30 days when stored at 2°C to 8°C.
F. Discard any unused reconstituted reagents and wTCR after 30 days or after the Master Lot expiration date, whichever comes first.
G. Controls are stable until the date indicated on the vials.
H. Reagents stored on-board the Panther System have 72 hours of on-board stability.
I. The Probe Reagent and Reconstituted Probe Reagent are photosensitive. Store the reagents protected f rom light. The specified reconstituted stability is based on 12 hours exposure of the Reconstituted Probe Reagent to two 60W f luorescent bulbs, at a distance of 17 inches (43 cm), and temperature less than 30°C. Light exposure of the Reconstituted Probe Reagent should be limited accordingly.
J. Upon warming to room temperature, some control tubes may appear cloudy or contain precipitates. Cloudiness or precipitation associated with controls does not affect control performance. The controls may be used whether they are clear or cloudy/precipitated. If clear controls are desired, solubilization may be expedited by incubating them at the upper end of the room temperature range (15°C to 30°C).
K. Do not freeze the reagents.
Specimen Collection and Storage
Specimens - Clinical material collected frompatient placed in an appropriate transport system. For the Aptima SARS-CoV-2 assay, this includes NP,nasal, mid-turbinate and OP swab specimens, or nasopharyngeal wash/aspirate and nasal aspirate specimen collection in viral transport medium(VTM/UTM),saline, LiquidAmies, orspecimen transportmedium(STM).
Samples - Represents amore generic termto describe any material for testing on the Panther Systemincluding specimens, specimens transferredintoaPanther Fusion Specimen LysisTube, Hologic Specimen Lysis Tube with solid cap, Custom Specimen Lysis Tube, Aptima Specimen Transfer Tube, AptimaMultitest Transport Tube, HologicDirect Load Tube,Hologic Direct Load Capture Cap Tube, and controls.
Note: Handle all specimens as if they contain potentially infectious agents. Use Universal Precautions.
Note: Take care to avoid cross-contamination during specimen handling steps. For example, discard used material without passing over open tubes.
Swab Specimen Collection
Collect NP swab, nasal swab, and OP swab specimens according to standard technique using a polyester-, rayon-, or nylon-tipped swab. Immediately place the swab specimen into 3mL of VTM or UTM. Swab specimens may alternatively be added to saline, Liquid Amies or STM. The Aptima Multitest Swab Specimen Collection Kit may be used f or the collection of OP and nasal swab samples. The Hologic Direct Load Collection Kit may be used for the collection of OP and nasal swab samples. The Hologic Direct Load Capture Cap Collection Kit - CLASSIQSwab is for the collection of OP and nasal swab samples. The Hologic Direct
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Load Capture Cap Collection Kit - FLOQSwab is for the collection of mid-turbinate and NP swab samples. After collection, specimens collected in VTM/UTM can be stored at 2°C to 8°C up to 96 hours bef ore transferring to the Specimen Lysis Tube (i.e., Panther Fusion Specimen Lysis Tube, Hologic Specimen Lysis Tube with solid cap, or Custom Specimen Lysis Tube) or Aptima Specimen Transf er Tube as described in the specimen processing section below. Remaining specimen volumes in VTM/UTM can be stored at -70°C. Af ter collection, specimens in the Aptima Multitest Tube, the Hologic Direct Load Tube, and the Hologic Direct Load Capture Cap Tube, may be stored at 2°C to 30°C up to 6 days. Note: It is recommended that specimens transferred to the Aptima Multitest Tube, the Hologic Direct Load Tube, and the Hologic Direct Load Capture Cap Tube, are stored capped and upright in a rack. The following types of VTM/UTM can be used.
· Remel MicroTest M4, M4RT, M5 or M6 formulations · Copan Universal Transport Medium · BD Universal Viral Transport Medium Note: Do not use medium that may contain Guanidium thiocyanate or any guanidinecontaining material.
Nasopharyngeal Wash/aspirate and Nasal Aspirate Specimen Collection Collect nasopharyngeal wash/aspirate and nasal aspirate specimens accordingtostandard techniques.
Specimen Processing
Capped Workflow using Aptima SARS-CoV-2 Assay Software
Specimen Processing using the Panther Fusion Specimen Lysis Tube A. Prior to testing on the Panther system, transf er 500 µL of the collected specimen* to a
Panther Fusion Specimen Lysis Tube. *Note: When testing frozen specimen, allow specimen to reach room temperature prior to processing.
Specimen Processing using the Aptima Specimen Transfer Tube A. Prior to testing on the Panther system, transfer 1 mL of the collected specimen* to an Aptima
Specimen Transfer Tube**. *Note: When testing frozen specimen, allow specimen to reach room temperature prior to processing. **Note: Alternatively, an unused Aptima Multitest Tube, Aptima Unisex Tube, or Hologic Direct Load Tube can be used.
B. Recap the Aptima Specimen Transfer Tube tightly.
C. Gently invert the tube 2 to 3 times to ensure complete mixture of the specimen.
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Specimen Processing for Specimen Collected with the Aptima Multitest Collection Kit A. Af ter placing the collected specimen* into the Aptima Multitest Tube using the Aptima
Multitest Collection Kit, no further processing is required. *Note: Allow specimen to reach room temperature prior to processing.
Specimen Processing for Specimen Collected with the Hologic Direct Load Tube Collection Kit A. After placing the collected specimen* into the Hologic Direct Load Tube, no further
processing is required. *Note: Allow specimen to reach room temperature prior to processing.
Uncapped Workflow using Aptima SARS-CoV-2 Assay Software
Specimen Processing using the Panther Fusion Specimen Lysis Tube A. Uncap the Panther Fusion Specimen Lysis Tube with penetrable cap. The penetrable cap
can be retained or a replacement solid cap can be used in the next step.
B. Prior to testing on the Panther system, transf er 500 µL of the specimen to the Panther Fusion Specimen Lysis Tube, with penetrable cap or replacement solid cap.
C. To avoid contact with the top of the tube, loosen the cap and place the sample tube into the sample rack.
D. Remove and discard the cap. Toavoid contamination, do not pass the cap over any other sample racks or sample tubes. Inspect the sample tube. If bubbles are present, carefully remove from the sample tube (for example, use the tip of a sterile swab or similar method). Note: Failure to remove bubbles may affect assay processing and cause invalid results.
E. Place the rack retainer on the sample rack and load the rack into the instrument.
Specimen Processing using the Hologic Specimen Lysis Tube with Solid Cap A. Uncap the Hologic Specimen Lysis Tube with solid cap and retain the cap.
B. Prior to testing on the Panther system, transf er 500 µL of the specimen to the Hologic Specimen Lysis Tube with solid cap.
C. It is recommended to recap the tube and gently invert three times to ensure viral inactivation and a homogeneous mixture.
D. To avoid contact with the top of the tube, loosen the cap and place the sample tube into the sample rack.
E. Remove and discard the cap. Toavoid contamination, do not pass the cap over any other sample racks or sample tubes. Inspect the sample tube. If bubbles are present, carefully remove from the sample tube (for example, use the tip of a sterile swab or similar method). Note: Failure to remove bubbles may affect assay processing and cause invalid results.
F. Place the rack retainer on the sample rack and load the rack into the instrument.
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Specimen Processing for Specimen Collected with the Hologic Direct Load Capture Cap Collection Kit - CLASSIQSwabs and the Hologic Direct Load Capture Cap Collection Kit FLOQSwabs A. After placing the collected specimen* into the Hologic Direct Load Capture Cap Tube, no
further processing is required. *Note: Allow specimen to reach room temperature prior to processing.
B. To avoid contact with the top of the tube, loosen the cap and place the sample tube into the sample rack.
C. Remove and discard the cap and swab. To avoid contamination, do not pass the cap over any other sample racks or sample tubes. Inspect the sample tube. If bubbles are present, caref ully remove f rom the sample tube (f or example, use the tip of a sterile swab or similar method). Note: If the swab wasn't captured by the cap, recap the tube to ensure that the swab is captured and removed from the tube. Direct Load Capture Cap tubes containing a swab should not be loaded into the Panther System. Note: Failure to remove bubbles may affect assay processing and cause invalid results.
D. Place the rack retainer on the sample rack and load the rack into the instrument.
Specimen Processing using a Custom Specimen Lysis Tube
A. Using a sterile, or non-sterile (unused) generic tube made of polypropylene plastic that is 12 mm to 13 mm in outer diameter and 75 mm to 100 mm in height, aliquot 0.78 mL ± 0.07 mL of bulk STM into the tube using a pipet or repeat pipettor.
Note: This step should be conducted in an area where SARS-CoV-2 specimens are NOT processed. Note: If tubes are prepared prior to use, recap the tube and store at 15°C to 30°C until use in specimen processing. Note: When the filled Custom Specimen Lysis Tube is stored closed, if no contaminants were introduced during the filling of the Custom Specimen Lysis Tube, the STM should be stable until the expiration date provided for the STM. Note: There may be an increased risk of contamination when using non-sterile (unused) tubes.
B. Uncap the custom Specimen Lysis Tube containing STM and retain the cap.
C. Prior to testing on the Panther system, transf er 500 µL of the specimen to the custom Specimen Lysis Tube containing STM.
D. It is recommended to recap the sample tube and gently invert three times to ensure viral inactivation and a homogeneous mixture.
E. To avoid contact with the top of the tube, loosen the cap and place the sample tube into the sample rack.
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F. Remove and discard the cap. Toavoid contamination, do not pass the cap over any other sample racks or sample tubes. Inspect the sample tube. If bubbles are present, carefully remove from the tube (for example, use the tip of a sterile swab or similar method).
Note: Failure to remove bubbles may affect assay processing and cause invalid results.
G. Place the rack retainer on the sample rack and load the rack into the instrument.
Specimen Processing for Specimen Collected with the Aptima Multitest Collection Kit
A. Obtain and f ollow instructions for Panther Fusion Specimen Lysis Tube (Step A), Hologic Specimen Lysis Tube with Solid Cap (Step A), or Custom Specimen Lysis Tube (Step A-B).
B. Prior to testing on the Panther system, transf er 500 µL of the collected specimen f rom the Aptima Multitest Tube to a Panther Fusion Specimen Lysis Tube, Hologic Specimen Lysis Tube or Custom Specimen Lysis Tube as described in the specimen processing sections above.
Sample Storage
A. Samples on board the Panther system may be archived for additional testing at a later time.
B. Storing samples before or after testing
1. Samples in the Aptima Multitest Tube, Aptima Specimen Transfer Tube, Panther Fusion Specimen Lysis Tube, Hologic Specimen Lysis Tube, Hologic Direct Load Tube, Hologic Direct Load Capture Cap Tube, or Custom Specimen Lysis Tube should be stored upright in the rack under the following condition: · 2°C to 30°C up to 6 days
2. For both capped and uncapped workflows, samples should be covered with a new, clean plastic film or foil barrier.
3. If assayed samples need to be frozen or shipped, · Capped workflows
Remove the penetrable cap and place a new non-penetrable cap on the specimen tubes. If samples need to be shipped for testing at another facility, recommended temperatures must be maintained. Prior to uncapping, specimen transport tubes must be centrifuged for 5 minutes at 420 Relative Centrifugal Force (RCF) to bringall of the liquid down to the bottomof thetube. Avoid splashing and cross-contamination.
· Uncapped workflows
Remove the solid cap and place a new solid cap on the specimen tubes. If samples need to be shipped for testing at another facility,recommendedtemperatures must be maintained. Prior to uncapping, specimen transport tubes must be centrifuged for 5 minutes at 420 Relative Centrifugal Force (RCF) to bring all of the liquid down to the bottomof the tube. Avoidsplashingand cross-contamination.
Note: Replacement tube closures and tube plugs should not be used to cover tubes when centrifuging, freezing, or shipping.
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Specimen Transport
Maintain specimen storage conditions as described in the Specimen Collection and Storage section on page 7.
Note: Specimens must be shipped in accordance with applicable national, international, and regional transportation regulations.
Specimen Pooling - Determining Appropriate Strategy for Implementation and Monitoring
When considering specimen pooling, laboratories should evaluate the appropriateness of a pooling strategy based on the positivity rate in the testing population and the efficiency of the pooling workflow. Refer to Appendix A of these Instructions for Use for additional information prior to implementation of specimen pooling.
Preparing Samples for Pooling
The following upper respiratory tract specimens authorized for use under the Emergency Use Authorization of the Aptima SARS-CoV-2 assay may be tested with sample pooling: nasopharyngeal, oropharyngeal, mid-turbinate, and nasal swab specimens collected into VTM/UTM, saline, Liquid Amies and specimen transport media (STM). Only specimens collected into a single type of media may be combined for each sample pool. For example, specimens collected in VTM/UTM should not be combined into a pool with specimens collected in Liquid Amies. Additionally, both neat specimens (those not prepared with STM for testing) and specimens prepared with STM for testing may be included in sample pooling. Each sample pool must be comprised of only neat or only STM prepared specimens. Recommended sample pooling workflow options for different specimen types are provided below.
For Specimens Collected in VTM/UTM, Saline or Liquid Amies
Customers may choose from one of the following two options to perform specimen processing f or pooled samples using Specimen Lysis Tubes with the Aptima SARS-CoV-2 assay.
Note: Hologic testing was performed using pooled samples generated from samples collected in a single collection medium type (i.e., VTM/UTM). Combination of multiple transport media types (e.g., VTM/UTM, saline, and Liquid Amies) in a single pool has not been evaluated.
Option 1: Specimen Preparation Instructions for Neat Samples Pooled Directly into a Specimen Lysis Tube (Hologic SLT, Custom SLT, and Panther Fusion SLT)
Perf orm the f ollowing procedure when pooling specimens collected in VTM/UTM, saline, or Liquid Amies by transf erring samples directly into a Specimen Lysis Tube (Hologic SLT, Custom SLT, or Panther Fusion SLT).
A. Determine the appropriate volume required f rom each individual specimen based on the pool size being implemented. The required specimen to STM ratio in the assay test sample must
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be maintained f or sample pooling. For example, if a pool size of 5 specimens is being utilized, 100 µL of each individual specimen (500 µL total) is required.
B. Uncap the Specimen Lysis Tube and retain the cap.
C. Prior to testing on the Panther system, carefully transfer the determined volume of each individual specimen from the specimen collection container to the Specimen Lysis Tube.
D. Ensure homogeneous mixing of each prepared sample pool. Note: Retain the individual specimens for additional testing, if required.
Option 2: Specimen Preparation Instructions for Samples Pooled Prior to Transferring to a Specimen Lysis Tube (Hologic SLT, Custom SLT, and Panther Fusion SLT)
Perf orm the f ollowing procedure when pooling specimens collected in VTM/UTM, saline, or Liquid Amies, by pooling the samples prior to transf erring into a Specimen Lysis Tube (Hologic SLT, Custom SLT, or Panther Fusion SLT).
A. Obtain a generic empty tube. This tube will not be loaded on the Panther System for testing.
B. Determine the appropriate volume required f rom each individual specimen based on the pool size being implemented. Note: The total volume of the pooled specimens must be greater than 500 µL to support transf er into a Specimen Lysis Tube.
C. Prior to testing on the Panther system, carefully transfer 500 µL of the pooled specimens from the generic tube into a Specimen Lysis Tube (Hologic SLT, Custom SLT, or Panther Fusion SLT).
D. Ensure homogenous mixing of each prepared sample pool. Note: Retain the individual specimens for additional testing, if required.
Option 3:
Specimen Preparation Instructions for Specimens Previously Transferred into Specimen Lysis Tubes and Pooled into an Empty Tube
Perf orm the f ollowing procedure when pooling specimens f rom Specimen Lysis Tubes (Hologic SLT, Custom SLT, or Panther Fusion SLT) by transferring directly into an empty tube per specifications in the Panther or Panther Fusion System Operators Manual.
A. Obtain a Panther system compatible empty tube.
B. Determine the appropriate volume required f rom each individual specimen based on the pool size being implemented. Specimens previously transferred into a Specimen Lysis Tube do not require additional dilution with STM prior to testing. Note: The recommended combined volume of each individual specimen is dependent upon the dimensions of tube being utilized. A Hologic representative can provide recommendations on minimum volume requirements for processing on the Panther system.
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Warnings and Precautions
Aptima® SARS-CoV-2
C. Prior to testing on the Panther system, carefully transfer the determined volume of each individual specimen f rom the Specimen Lysis Tubes (Hologic SLT, Custom SLT, or Panther Fusion SLT) to the Panther system compatible empty tube.
D. Ensure homogeneous mixing of each prepared sample pool.
E. Retain the individual specimens for additional testing if required.
For Specimens Collected in Aptima Multitest Transport Tubes Specimen Preparation Instructions for Samples Pooled Directly into a Generic Tube Perf orm the f ollowing procedure when pooling specimens collected in Aptima Multitest Transport Tubes by transferring individual specimens directly into an empty tube per specifications in the Panther or Panther Fusion System Operators Manual.
A. Obtain a Panther system compatible empty tube.
B. Determine the appropriate volume required from each individual specimen based on the pool size being implemented. Specimens collected in an Aptima Multitest Transport Tube do not require additional dilution with STM prior to testing. Note: The recommended combined volume of each individual specimen is dependent upon the dimensions of tube being utilized. A Hologic representative can provide recommendations on minimum volume requirements for processing on the Panther system.
C. Prior to testing on the Panther system, carefully transfer the determined volume of each individual specimen from the Aptima Multitest Transport Tubes to the empty tube.
D. Ensure homogeneous mixing of each prepared sample pool.
E. Retain the individual specimens for additional testing if required.
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Aptima® SARS-CoV-2
Panther System
Panther System
Reagents f or the Aptima SARS-CoV-2 assay are listed below f or the Panther System. Reagent Identification Symbols are also listed next to the reagent name.
Reagents and Materials Provided Aptima SARS-CoV-2 Assay Kit PRD-06419
250 tests (2 boxes)
Aptima SARS-CoV-2 Refrigerated Box (Box 1 of 2) (store at 2°C to 8°C upon receipt)
Symbol Component
Quantity 250 test kit
A
Aptima SARS-CoV-2 Amplification Reagent
Non-infectious nucleic acids dried in buffered solution containing
< 5% bulking agent.
1 vial
E
Aptima SARS-CoV-2 Enzyme Reagent
Reverse transcriptase and RNA polymerase dried in HEPES buffered
solution containing < 10% bulking reagent.
1 vial
P
Aptima SARS-CoV-2 Probe Reagent
1 vial
Non-infectious chemiluminescent DNA probes dried in succinate buffered
solution containing < 5% detergent.
IC
Aptima SARS-CoV-2 Internal Control
1 vial
Aptima SARS-CoV-2 Room Temperature Box (Box 2 of 2) (store at 15°C to 30°C upon receipt)
Symbol Component
AR ER PR S TCR
Aptima SARS-CoV-2 Amplification ReconstitutionSolution Aqueous solution containing preservatives.
Aptima SARS-CoV-2 Enzyme ReconstitutionSolution HEPES buffered solution containing a surfactant and glycerol.
Aptima SARS-CoV-2 Probe ReconstitutionSolution Succinate buffered solution containing < 5% detergent.
Aptima SARS-CoV-2 Selection Reagent 600 mM borate buffered solution containing surfactant.
Aptima SARS-CoV-2 Target CaptureReagent Buffered salt solution containing solid phase and capture oligomers.
Reconstitution Collars Master Lot Barcode Sheet
Quantity 250 test kit 1 x 27.7 mL 1 x 11.1 mL 1 x 35.4 mL 1 x 108 mL 1 x 54 mL
3 1 sheet
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Panther System
Aptima® SARS-CoV-2
Materials Required and Available Separately
Note: Materials available from Hologic have catalog numbers listed, unless otherwise specified.
Cat. No.
Panther System
303095
Aptima Assay Fluids Kit
(Aptima Wash Solution, Aptima Buffer for Deactivation Fluid, and Aptima Oil Reagent)
303014 (1000 tests)
Aptima Auto Detect Kit Multi-tube units (MTUs) Panther Waste Bag Kit Panther Waste Bin Cover Or Panther Run Kit
contains MTUs, waste bags, waste bin covers, assay fluids, and auto detects
303013 (1000tests) 104772-02
902731 504405 303096 (5000 tests)
Tips, 1000 µL conductive, liquid sensing
Aptima SARS-CoV-2 Controls Kit
PC - Aptima SARS-CoV-2 Positive Control. Non-infectious nucleic acid in a buffered solution containing < 5% detergent. Quantity 5 x 1.7 mL
NC - Aptima SARS-CoV-2 Negative Control. A buffered solution containing < 5% detergent. Quantity 5 x 1.7 mL
10612513 (Tecan) PRD-06420
Aptima Multitest Swab Specimen Collection Kit
PRD-03546
Hologic Direct Load Tube Collection Kit
PRD-06997
Hologic Direct Load Capture Cap Collection Kit - CLASSIQSwabs PRD-06951
Hologic Direct Load Capture Cap Collection Kit - FLOQSwabs PRD-06952 Aptima
Specimen Transf er Kit
301154C
Aptima Specimen TransferKit - printable
PRD-05110
Aptima Unisex Swab Specimen Collection Kit forEndocervical and 301041 Male Urethral Swab Specimens
Panther Fusion Specimen Lysis Tubes, 100 per bag
tube contains 0.71 mL of STM with a penetrable cap
Hologic Specimen Lysis Tubes, 100 each
tube contains 0.71 mL of STM with a solid cap (for uncapped workflow)
Hologic Specimen Lysis Tubes, 1200 each
tube contains 0.71 mL of STM with a solid cap (for uncapped workflow)
PRD-04339 PRD-06554 PRD-06660
Specimen Transport Medium, 1 bottle, 80mL (for uncapped workflow)
PRD-04423
Bleach, 5% to 7% (0.7M to 1.0M) sodium hypochlorite solution
Disposable gloves
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Aptima® SARS-CoV-2
Panther System
Cat. No.
Hologic Solid Cap for use with PRD-06660*, 100 caps per bag
PRD-06723
*a single-use cover for the Hologic Specimen Lysis Tube (PRD-06660 only) after testing as part of the uncapped workflow
Hologic Solid Cap for use with PRD-06951* and PRD-06952*, 100 caps per bag
*a single-use cover for the Direct Load Capture Cap (PRD-06951 and PRD06952) after testing as part of the uncapped workflow
PRD-07028
Hologic Flange Cap 12/13mm, natural
PRD-06850
Fisherbrand VersaClosure Tube Closures*, 1000 per pack
02-707
*a single-use tube cover for the Hologic Specimen Lysis Tube (PRD-06554 only) after testing as part of the uncapped workflow
Replacement Caps for the 250-test kits
--
Amplification and Probe reagent reconstitution solutions CL0041 (100 caps)
Enzyme Reagent reconstitution solution
501616 (100 caps)
TCR and Selection reagent
CL0040 (100 caps)
Optional Materials
Cat. No.
Hologic Bleach Enhancer for Cleaning
302101
for routine cleaning of surfaces and equipment
Generic Sample Tube (for Custom SLT)
--
*Size: 12 x 75 mm to 13 x 100 mm (including 12 x 100 mm, 13 x 75 mm, and 13 x 82 mm) Material: Polypro py le n e plastic Non-ste rile (unused ) or sterile Round, flat bottom, or conical (skirted conical)
Tube rocker
--
Panther System Test Procedure
Note: Refer to the Panther/Panther System Operator's Manual for additional procedural information.
A. Work Area Preparation
Clean work surfaces where reagents and samples will be prepared. Wipe down work surfaces with 2.5% to 3.5% (0.35M to 0.5M) sodium hypochlorite solution. Allow the sodium hypochlorite solution to contact surf aces for at least 1 minute and then f ollow with a water rinse. Do not allow the sodium hypochlorite solution to dry. Cover the bench surface on which the reagents and samples will be prepared with clean, plastic-backed absorbent laboratory bench covers.
B. Reagent Reconstitution/Preparation of a New Kit
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Panther System
Aptima® SARS-CoV-2
Note: Reagent reconstitution should be performed prior to beginning any work on the Panther System.
1. Toreconstitute Amplification, Enzyme, and Probe Reagents, combine the bottles of lyophilized reagent with the reconstitution solution. If refrigerated, allow the reconstitution solutions to reach room temperature before use. a. Pair each reconstitution solution with its lyophilized reagent. Ensure that the reconstitution solution and reagent have matching label colors before attaching the reconstitution collar.
b. Check the lot numbers on the Master Lot Barcode Sheet to ensure that the appropriate reagents are paired.
c. Open the lyophilized reagent vial and firmly insert the notched end of the reconstitution collar into the vial opening (Figure 1, Step 1).
d. Open the matching reconstitution solution, and set the cap on a clean, covered work surf ace.
e. While holding the reconstitution solution bottle on the bench, f irmly insert the other end of the reconstitution collar into the bottle opening (Figure 1, Step 2).
f. Slowly invert the assembled bottles. Allow the solution to drain from the bottle into the glass vial (Figure 1, Step 3).
g. Thoroughly mix the solution in the glass vial by swirling (Figure 1, Step 4).
h. Wait for the lyophilized reagent to go into solution, then invert the assembled bottles again, tilting at a 45° angle to minimize foaming (Figure 1, Step 5). Allow all of the liquid to drain back into the plastic bottle.
i. Remove the reconstitution collar and glass vial (Figure 1, Step 6).
j. Recap the plastic bottle. Record operator initials and reconstitution date on the label (Figure 1, Step 7).
k. Discard the reconstitution collar and glass vial (Figure 1, Step 8).
Option: Additional mixing of the Amplification, Enzyme, and Probe Reagents using a tube rocker is allowed. The reagents may be mixed by placing the recapped plastic bottle on a tube rocker set to 20 RPM (or equivalent) f or a minimum of 5 minutes.
Warning: Avoid creating foam when reconstituting reagents. Foam compromises the levelsensing in the Panther System.
Warning: Adequate mixing of the reagents is necessary to achieve expected assay results.
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Panther System
Figure 1. Panther System Reconstitution Process
2. Prepare Working Target Capture Reagent (wTCR) a. Pair the appropriate bottles of TCR and IC.
b. Check the reagent lot numbers on the Master Lot Barcode Sheet to make sure that the appropriate reagents in the kit are paired.
c. Open the bottle of TCR, and set the cap on a clean, covered work surface.
d. Open the IC bottle and pour the entire contents into the bottle of TCR. Expect a small amount of liquid to remain in the IC bottle.
e. Cap the bottle of TCR and gently swirl the solution to mix the contents. Avoid creating foam during this step.
f. Record operator initials and the current date on the label.
g. Discard the IC bottle and cap.
3. Prepare Selection Reagent a. Check the lot number on the reagent bottle to make sure it matches the lot number on the Master Lot Barcode Sheet.
b. Record operator initials and the current date on the label.
Note: Thoroughly mix by gently inverting all reagents prior to loading on the system. Avoid creating foam during inversion of reagents.
C. Reagent Preparation for Previously Reconstituted Reagents
1. Previously reconstituted Amplification, Enzyme, and Probe Reagents must reach room temperature (15°C to 30°C) prior to the start of the assay. Option: The reagents may be brought to room temperature by placing the reconstituted Amplif ication, Enzyme, and Probe Reagents on a tube rocker set to 20 RPM (or equivalent) f or a minimum of 25 minutes.
2. If reconstituted Probe Reagent contains precipitate that does not return to solution at room temperature, heat the capped bottle at a temperature that does not exceed 62°C for 1 to 2 minutes. After this heat step, the Probe Reagent may be used even if residual precipitate remains. Mix Probe Reagent by inversion, being careful not to induce f oam, prior to loading onto the system.
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Panther System
Aptima® SARS-CoV-2
3. Thoroughly mix each reagent by gently inverting prior to loading on the system. Avoid creating f oam during inversion of reagents. This step is not required if reagents are loaded onto the system directly after mixing on the tube rocker.
4. Do not top off reagent bottles. The Panther System will recognize and reject bottles that have been topped off.
5. Adequate mixing of the reagents is necessary to achieve expected assay results.
D. Specimen Handling using Panther Fusion Specimen Lysis Tube or Aptima Specimen Transf er Tube
Note: Prepare specimens per the Specimen Processing instructions in the Specimen Collection and Storage section before loading specimens onto the Panther system.
1. Inspect sample tubes bef ore loading into the rack. If a sample tube contains bubbles or has a lower volume than is typically observed, gently tap the bottom of the tube to bring contents to the bottom.
Note: For samples transferred to the Panther Fusion Specimen Lysis Tube or the Aptima Specimen Transfer Tube, to avoid a processing error, ensure adequate specimen volume is added to the tube. When adequate collected specimen is added to the tube, there is sufficient volume to perform 3 nucleic acid extractions.
E. Specimen Handling using Hologic Specimen Lysis Tube or Custom Specimen Lysis Tube
1. Prepare specimens per the specimen processing instructions in the Specimen Collection and Storage section.
Note: For samples transferred to the Hologic Specimen Lysis Tube or a custom Specimen Lysis Tube, to avoid a processing error, ensure adequate specimen volume is added to the tube. When adequate collected specimen is added to the tube, there is sufficient volume to perform 2 nucleic acid extractions.
Note: When using the Aptima SARS-CoV-2 uncapped tube assay software, remove the cap from the Positive and Negative control before loading onto the Panther system.
F. System Preparation
1. Set up the system according to the instructions in the Panther/Panther Fusion System Operator's Manual and Procedural Notes. Make sure that the appropriately sized reagent racks and TCR adapters are used.
2. Load samples.
Procedural Notes
A. Controls
1. Towork properly with the Aptima Assay software for the Panther system, one pair of controls is required. The Aptima SARS-CoV-2 positive and negative controls can be loaded in any rack position or in any Sample Bay Lane on the Panther system. Patient specimen pipetting will begin when one of the following two conditions has been met: a. A pair of controls is currently being processed by the system.
b. Valid results for the controls are registered on the system.
2. Once the control tubes have been pipetted and are processing f or a specif ic reagent kit, patient specimens can be run with the associated kit up to 24 hours unless:
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Aptima® SARS-CoV-2
Panther System
a. Controls results are invalid.
b. The associated assay reagent kit is removed from the system.
c. The associated assay reagent kit has exceeded stability limits.
3. Each Aptima control tube can be tested once. Attempts to pipette more than once from the tube can lead to processing errors.
4. Patient specimen pipetting begins when one of the following two conditions is met: a. Valid results for the controls are registered on the system.
b. A pair of controls is currently in process on the system.
B. Temperature
Room temperature is defined as 15°C to 30°C.
C. Glove Powder
As in any reagent system, excess powder on some gloves may cause contamination of opened tubes. Powderless gloves are recommended.
D. Lab Contamination Monitoring Protocol for the Panther System
There are many laboratory-specific factors that may contribute to contamination, including testing volume, workflow, disease prevalence and various other laboratory activities. These f actors should be taken into consideration when contamination monitoring f requency is being established. Intervals f or contamination monitoring should be established based on each laboratory's practices and procedures.
To monitor for laboratory contamination, the following procedure may be performed using the Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens:
1. Label swab transport tubes with numbers corresponding to the areas to be tested. 2. Remove the specimen collection swab (blue shaft swab with green printing) from its
packaging, wet the swab in the specimen transport medium (STM), and swab the designated area using a circular motion. 3. Immediately insert the swab into transport tube. 4. Carefully break the swab shaft at the score line; use care to avoid splashing of the contents. 5. Recap the swab transport tube tightly. 6. Repeat Steps 2 to 5 for each area to be swabbed.
E. If the results are positive, see Interpretation of Results. For additional Panther systemspecific contamination monitoring information, contact Hologic Technical Support.
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Quality Control
Aptima® SARS-CoV-2
Quality Control
A run or specimen result may be invalidated by the Panther system if problems occur while performing the assay. Specimens with invalid results must be retested.
Negative and Positive Controls To generate valid results, a set of assay controls must be tested. One replicate of the negative assay control and positive assay control must be tested each time a new kit is loaded on the Panther system or when the current set of valid controls have expired.
The Panther system is configured to require assay controls run at an administrator-specified interval of up to 24 hours. Software on the Panther system alerts the operator when assay controls are required and does not start new tests until the assay controls are loaded and have started processing.
During processing, criteria f or acceptance of the assay controls are automatically verif ied by the Panther system. To generate valid results, the assay controls must pass a series of validity checks perf ormed by the Panther system.
If the assay controls pass all validity checks, they are considered valid for the administrator-specif ied time interval. When the time interval has passed, the assay controls are expired by the Panther system which requires a new set of assay controls be tested prior to starting any new samples.
If any one of the assay controls fails the validity checks, the Panther system automatically invalidates the af f ected samples and requires a new set of assay controls be tested prior to starting any new samples.
Internal Control An internal control is added to each sample with the wTCR. During processing, the internal control acceptance criteria are automatically verif ied by the Panther system sof tware. Detection of the internal control is not required f or samples that are positive f or SARS-CoV-2. The internal control must be detected in all samples that are negative for SARS-CoV-2 targets; samples that f ail to meet that criteria will be reported as Invalid. Each sample with an Invalid result must be retested.
The Panther system is designed to accurately verify processes when procedures are performed following the instructions provided in this package insert and the Panther/Panther Fusion System Operator's Manual.
Interpretation of Results
The Panther system automatically determines the test results for samples and controls. A test result may be negative, positive, or invalid.
Table 1 shows the possible results reported in a valid run with result interpretations.
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Aptima® SARS-CoV-2
Limitations
Table 1: Result Interpretation
SARS-CoV-2 Result Neg POS
IC Result Valid Valid
Interpretation SARS-CoV-2 not detected.
SARS-CoV-2 detected.
Invalid
Invalid
Invalid. There was an error in the generation of the result; retestsample.
Note: Detection of internal control is not required for samples that are positive for SARS-CoV-2.
Interpretation of Results for Pooled Samples
Negative: Negative results from pooled sample testing should not be treated as def initive. If the patient's clinical signs and symptoms are inconsistent with a negative result and results are necessary for patient management, then the patient should be considered for individual testing. The utilization of sample pooling should be indicated f or any specimens with reported negative results.
Positive: Specimens with a positive sample pool result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.
Invalid: Specimens with an invalid result must be tested individually prior to reporting a result. However, in instances of an invalid run, repeat testing of pooled specimens may be appropriate depending on the laboratory workflow and required result reporting time.
Limitations
A. Use of this assay is limited to personnel who are trained in the procedure. Failure to follow these instructions may result in erroneous results.
B. Reliable results are dependent on adequate specimen collection, transport, storage, and processing.
C. Avoid contamination by adhering to good laboratory practices and to the procedures specified in this package insert.
D. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other management decisions.
E. A positive result indicates the detection of nucleic acid f rom the relevant virus. Nucleic acid may persist even after the virus is no longer viable.
F. Nasopharyngeal wash/aspirate or nasal aspirates and self -collected under supervision of or healthcare provider collected nasal and mid-turbinate nasal swabs are additional acceptable upper respiratory specimens that can be tested with the Aptima SARS-CoV-2 assay; however, performance with these specimen types have not been determined.
G. Nasopharyngeal wash/aspirate and nasal aspirates specimen types should not be pooled.
H. Sample pooling has only been validated using nasopharyngeal swab specimens.
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Conditions of Authorization for Labs
Aptima® SARS-CoV-2
I. Samples should only be pooled when testing demand exceeds laboratory capacity and/or when testing reagents are in short supply.
J. The Aptima SARS-CoV-2 assay may be used to test asymptomatic individuals, although performance has not been demonstrated in an asymptomatic population. This assay has been shown to exhibit high sensitivity when tested with the FDA reference panel.
K. Use of the Aptima SARS-CoV-2 assay in a general, asymptomatic screening population is intended to be used as part of an infection control plan, that may include additional preventative measures, such as a predef ined serial testing plan or directed testing of highrisk individuals. Negative results should be considered presumptive and do not preclude current or f uture infection obtained through community transmission or other exposures. Negative results must be considered in the context of an individual's recent exposures, history, and presence of clinical signs and symptoms consistent with COVID-19.
L. Asymptomatic individuals infected with COVID-19 may not shed enough virus to reach the limit of detection of the test, giving a f alse negative result.
M. In the absence of symptoms, it is difficult to determine if asymptomatic individuals have been tested too late or too early. Therefore, negative results in asymptomatic individuals may include individuals who were tested too early and may become positive later, individuals who were tested too late and may have serological evidence of infection, or individuals who were never infected.
N. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
Conditions of Authorization for Labs
The Aptima SARS-CoV-2 assay Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-2019covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
However, to assist clinical laboratories using the Aptima SARS-CoV-2 assay, the relevant Conditions of Authorization are listed below.
A. Authorized laboratories1 using the Aptima SARS-CoV-2 assay must include with result reports of the Aptima SARS-CoV-2 assay, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
B. Authorized laboratories using specimen pooling strategies when testing patient specimens with the authorized test must include with test result reports for specific patients whose specimen(s) were the subject of pooling, a notice that pooling was used during testing and that "Patient specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing."
C. Authorized laboratories using the Aptima SARS-CoV-2 assay must perf orm the Aptima SARS-CoV-2 assay as outlined in the Aptima SARS-CoV-2 assay Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized
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extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to perform the Aptima SARS-CoV-2 assay are not permitted.
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Conditions of Authorizationfor Labs
D. Authorized laboratories implementing pooling strategies for testing patient specimens must use the "Appendix A: Specimen Pooling Implementation and Monitoring Guidelines" provided in the authorized tests' Instructions for Use/Package Insert to evaluate the appropriateness of continuing to use such strategies based on the recommendations in the protocol.
E. Authorized laboratories that receive the Aptima SARS-CoV-2 assay must notif y the relevant public health authorities of their intent to run the test prior to initiating testing.
F. Authorized laboratories using the Aptima SARS-CoV-2 assay must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
G. Authorized laboratories must keep records of specimen pooling strategies implemented including type of strategy, date implemented, and quantities tested, and test result data generated as part of the Protocol f or Monitoring of Specimen Pooling Strategies. For the f irst 12 months from the date of their creation, such records will be made available to FDA within 48 business hours f or inspection upon request, and will be made available within a reasonable time of FDA's request after 12 months from the date of their creation.
H. Authorized laboratories must collect inf ormation on the performance of the test and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and Hologic (molecularsupport@hologic.com) any suspected occurrence of false positive or f alse negative results and significant deviations from the established performance characteristics of the test of which they become aware.
I. All laboratory personnel using the test must be appropriately trained in TMA techniques and use appropriate laboratory and personal protective equipment when handling this kit, and use the test in accordance with the authorized labeling.
J. Hologic, its authorized distributor(s) and authorized laboratories using the Aptima SARS-CoV2 assay must ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.
1 The letter of authorization refers to "Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests" as "authorized laboratories."
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Aptima Assay Performance
Aptima® SARS-CoV-2
Aptima Assay Performance
Analytical Sensitivity
The analytical sensitivity (limit of detection or LoD) of the Aptima SARS-CoV-2 assay using the Panther Fusion Specimen Lysis Tube workflow was determined by testing serial dilutions of pooled negative clinical nasopharyngeal swab specimens spiked with inactivated cultured SARSCoV-2 virus (USA-WA1/2020; BEI Resources; NR-52281). Ten replicates of each serial dilution were evaluated using each of two assay reagent lots across two Panther systems. The LoD was determined to be 0.01 TCID50/mL in the test sample (0.026 TCID50/mL in the neat, unprocessed sample) and verified by testing an additional 20 replicates with one assay reagent lot. The LoD was also confirmed using saline, Liquid Amies and specimen transport medium (STM) swab collection media.
The analytical sensitivity of the Aptima SARS-CoV-2 assay was additionally evaluated using nucleic acid materials from three commercial vendors. Serial dilutions of the nucleic acid materials were made in Aptima Multitest tubes (containing STM and 10,000 copies/mL HeLa cells) and 20 or more replicates at each level were tested using each of two assay reagent lots across two Panther systems. For each material, the lowest dilution resulting in 95% detection was 83 copies/mL in the test sample. A test sample concentration of 83 copies/mL correlates to 323.7 copies/mL of material added to the Aptima Multitest tube or 212.5 copies/mL of material added to a neat, unprocessed Specimen Lysis Tube (SLT). The nucleic acid materials and the perf ormance of the 83 copies/mL dilution are listed in Table 2.
Table 2: Analytical Sensitivity Evaluation of Commercial Material
Vendor and Reference # and
N
N
%
Avg StdDev %
Name
Lot #
Valid Positive Positive kRLU kRLU
CV
ZeptoMetrixSAR S-CoV-2
External Run Control
NATSARS(COV2) -ERC 324332
40
SeraCare
SARS-Cov-2
0505-0126
40
Ref erence
10483977
Material
Exact Diagnostics
COV019
40
SARS-CoV-2
20033001
Standard
39
98%
965
212 21.90%
40
100%
728
38
5.30%
40
100%
1032
152 14.70%
FDA SARS-CoV-2 Reference Panel Testing
The evaluation of sensitivity and MERS-CoV cross-reactivity was perf ormed using reference material (T1), blinded samples and a standard protocol provided by the FDA. The study included a range f inding study and a confirmatory study for LoD. Blinded sample testing was used to establish specificity and to
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confirm the LoD. The study was performed on the fully automated Panther system. The results are summarized in Table 3.
Table 3: Summary of LoD Confirmation Results using the FDA SARS-CoV-2 Reference Panel
Reference Materials Provided by FDA
Specimen Type
Product LoD
Cross-Reactivity
SARS-CoV-2
600 NDU/mL
N/A
NP Swabs in VTM/UTM
MERS-CoV
N/A
ND
NDUmL = RNA NAAT detectable units/mL. N/A = Not applicable. ND = Not detected.
Analytical Sensitivity with the Aptima Specimen Transfer Tube Workflow
The determined 0.026 TCID50/mL analytical sensitivity (limit of detection) of the Aptima SARSCoV-2 assay in the neat, unprocessed sample was conf irmed using the Aptima Specimen Transf er Tube specimen preparation workflow. Confirmation was perf ormed using inactivated cultured SARS-CoV-2 virus (USA-QA1/2020; BEI Resources; NR-52281) in negative clinical nasopharyngeal (NP) swab, saline, Liquid Amies and specimen transport medium (STM) swab collection media by testing 20 replicates with one reagent lot.
Precision/Reproducibility
The Aptima SARS-CoV-2 assay precision/reproducibility was evaluated on three Panther systems at a single site using f our panel members. Testing was performed using three lots of assay reagents with two operators over six days. Two runs were performed per operator per day f or a total of 36 runs. Each of the f our panels was tested in three replicates per run for a total of 108 replicates per panel.
Positive and negative panel members consisted of pooled clinical nasopharyngeal (NP) swab matrix combined with Solution Transport Media (STM) in a ratio of 1:1.56. Positive panel members spiked with inactivated cultured SARS-CoV-2 virus at 0.1x LoD (High Negative), 1x LoD (Low Positive) and 5x LoD (Moderate Positive).
The agreement with expected results was 100% in the Negative, Low Positive and Moderate Positive panel members. The High Negative panel member was 10x below the assay LoD, theref ore a mix of positive and negative results were expected. This panel gave 68/108 (63%) positive results. Agreement with expected results for all four panels is shown in Table 4.
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Table 4: Agreement of Aptima SARS-CoV-2 Assay Results with Expected Results
Panel
Panel
Panel Conc. Expected
N
Mean
Description Composition TCID50/mL
Result Positive N Tested kRLU
Negative
N/A
High
N/A
Negative
0
108
289
Agreement w/Expected
(95% CI) 100%
(96.6-100)
Negative Low Positive
0.1x LoD 1.0x LoD
0.001 0.01
N/A
68
108
627
N/A
Positive 108
100%
108
1131
(96.6-100)
Moderate Positive
5.0x LoD
0.05
Positive 108
108
1147
100%
(9
0)
6.6-10
The total SARS-CoV-2 signal variability measured as %CV ranged from 2.75% to 3.84% in Negative, Low Positive, and Moderate Positive panel members. For the sources of variation all six factors evaluated had %CV values <3.0% as shown in Table 5. The High Negative panel member is 10x below the assay LoD and the %CV for this panel is expected to be higher than the others. The highest source of variability for this panel was within-run variability.
Table 5: kRLU Signal Variability of the Aptima SARS-CoV-2 Assay by Panel Member
Between Days
Between Instruments
Between Operators
Between Lots
Between Runs
Within Runs
Total
Panel
SD
CV (%)
SD
CV (%)
SD
CV (%)
SD
CV (%)
SD
CV (%)
SD
CV (%)
SD
CV (%)
Negative 0.91 0.31 4.97 1.72 0.0
High
Negative* 30.45 4.85 0.0
0.0
0.0
Low
6.46 0.57 6.74 0.60 0.0
Positive
0.0 4.04 1.40 0.0 0.0 6.75 2.33 9.35 3.23 0.0 0.0 0.0 0.0 0.0 244.08 38.91 245.97 39.21 0.0 28.10 2.48 0.0 0.0 31.77 2.81 43.43 3.84
Moderate 8.53 0.74 5.59 0.49 0.0 Positive
0.0 22.98 2.00 11.0 0.96 15.59 1.36 31.59 2.75 6
*Panel was built to 10x below the assay LoD. Higher variability is expected in this panel. Note: In the event that variability from some factors is numerically negative, SD and CV are shown as 0.0.
Inclusivity
The inclusivity of the Aptima SARS-CoV-2 assay was evaluated using in silico analysis of the assay target capture oligos, amplification primers, and detection probes in relation to 49,741
SARS-CoV-2 sequences available in the NCBI and GISAID gene databases as of July 16th, 2020. Any sequence with missing or ambiguous sequence information was removed from the analysis f or that region, resulting in 49,659 sequences evaluated f or the f irst target region of the assay and 49,514 f or the second target region. The in silico analysis showed 100% homology to
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the assay oligos of both target systems for 48,180 (96.9%) of the evaluated sequences and 100% homology to the assay oligos of at least one target system for 49,730 (99.98%) of sequences. There were no evaluated sequences with identified mismatches predicted to impact binding or perf ormance of both target systems.
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Aptima Assay Performance
Analytical Specificity and Microbial Interference
The analytical specif icity of the Aptima SARS-CoV-2 assay was evaluated by testing 30 microorganisms representing common respiratory pathogens or closely related species (Table 6). Bacteria were tested at 106 CFU/mL and viruses were tested at 105 TCID50/mL, except where noted. Microorganisms were tested with and without the presence of SARS-CoV-2 inactivated virus at 3x LoD. Analytical specif icity of the Aptima SARS-CoV-2 assay was 100% with no evidence of microbial interference.
In addition to microorganism testing, in silico analysis was performed to assess the specificity of the assay in relation to the microorganisms listed in Table 6. The in silico analysis showed no probable cross reactivity to any of the 112 GenBank sequences evaluated.
Table 6: Aptima SARS-CoV-2 Analytical Specificity and Microbial Interference Microorganisms
Microorganism
Concentration
Microorganism
Concentration
Human coronavirus 229E
1E+5 TCID50/mL
Parainfluenza virus 1
1E+5 TCID50/mL
Human coronavirus OC43 Human coronavirus HKU11
Human coronavirus NL63 SARS-c o ro n av i rus 1 MERS-c o ro n av i rus
Adenovirus (e.g. C1 Ad. 71) Human Metapneumovirus
(h MPV)
1E+5 TCID50/mL 1E+6 copies/mL 1E+4 TCID50/mL 1E+6 copies/mL 1E+4 TCID50/mL 1E+5 TCID50/mL
1E+6 TCID50/mL
Parainfluenza virus 2 Parainfluenza virus 3 Parainfluenza virus 4
Influenza A Influenza B Enterovirus (e.g. EV68)
Rh i n o v i rus
1E+5 TCID50/mL 1E+5 TCID50/mL 1E+3 TCID50/mL 1E+5 TCID50/mL 2E+3 TCID50/mL 1E+5 TCID50/mL
1E+4 TCID50/mL
Respiratory syncytial virus Chlamydia pneumoniae Haemophilus influenzae
Bordetella pertussis Pneumocystis jirovecii (PJP)
Candida albicans Staphylococcus epidermidis Pooled human nasal wash2 - to represent diverse microbial flora
in human respiratory tract
1E+5 TCID50/mL 1E+6 IFU/mL 1E+6 CFU/mL 1E+6 CFU/mL 1E+6 nuc/mL 1E+6 CFU/mL 1E+6 CFU/mL
N/A
Legionella pneumophila Mycobacterium tuberculosis Streptococcus pneumoniae
Streptococcus pyogenes Streptococcus salivarius Mycoplasma pneumoniae Pseudomonas aeruginosa
1E+6 CFU/mL 1E+6 TCID50/mL
1E+6 CFU/mL
1E+6 CFU/mL 1E+6 CFU/mL 1E+6 CFU/mL 1E+6 CFU/mL
1 Cultured virus and whole genome purified nucleic acid for Human coronavirus HKU1 and SARS-coronavirus are not readily available. HKU1 and SARS-coronavirus IVTs corresponding to the ORF1ab gene regions targeted by the assay were used to evaluate cross-reactivity and microbial interference. 2 In place of evaluating pooled human nasal wash, testing of 30 individual negative clinical NP swab specimens was performed to represent diverse microbial flora in the human respiratory tract.
Carryover Contamination
The carryover contamination rate of the Aptima SARS-CoV-2 assay f or samples tested with the capped tube and uncapped tube workflows was determined. The evaluation consisted of testing high titer SARS-CoV-2 target panels ~5 logs above the assay LoD in a checkerboard pattern
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with negative panels in four runs on three Panther systems. The capped tube workflow had an
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Aptima Assay Performance
Aptima® SARS-CoV-2
observed carryover rate of 0%, whereas the uncapped tube workflow carryover rate was 0.67% with 5 of 744 negative samples evaluated giving a false positive result.
Uncapped Workflow Performance
The perf ormance of the Aptima SARS-CoV-2 assay using the uncapped tube workflow was evaluated under variable factors including multiple operators, runs per day, and testing days. The uncapped workf low was evaluated with two tube types pref illed to 0.780 mL with specimen transport medium (STM) as representative of Hologic supplied Specimen Lysis Tubes (SLTs) and with two empty tube types as representative of custom SLTs. A variety of tube sizes covering the recommended tube dimensions and materials were included in the evaluation. The workf low evaluation included both high concentration SARS-CoV-2 positive and negative panels processed using the uncapped tube workflow.
The Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) was calculated in relation to the expected result of the panel, as shown in Table 7. The uncapped tube workflow showed positive and negative agreements of 100% (99.4% - 100%) and 99.7% (98.9% - 99.9%) respectively.
Table 7: Aptima SARS-CoV-2 Uncapped Workflow Performance
Aptima SARS-CoV-2 Result
Po s i ti v e Neg ati v e
To tal
Expected SARS-CoV-2 Result
Po s i ti v e
Neg ati v e
639
2
0
638
639
640
To tal 641 638 1279
Overall Agreement: 99.8% (99.4% - 100%) Positive Agreement: 100% (99.4% - 100%) Negative Agreement: 99.7% (98.9% - 99.9%)
Uncapped Tube Workflow Specimen and STM Volume Guardbands
The perf ormance of the Aptima SARS-CoV-2 assay was evaluated under specimen and STM volume variance conditions of up to ±20% of those specified f or processing specimens with the custom SLT workflow. Positive SARS-CoV-2 positive panels at the LoD of the assay (i.e.,0.010 TCID50/mL) and negative panels were evaluated at each volume guardband variance condition. Agreement to expected result was 100% f or the Aptima SARS-CoV-2 assay.
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Clinical Performance
Clinical Performance
The clinical performance of the Aptima SARS-CoV-2 assay was evaluated in comparison to the Panther Fusion SARS-CoV-2 assay (Hologic, Inc.) using a panel of remnant clinical specimens. For the study, remnant clinical nasopharyngeal specimens were collected from US patients with signs and symptoms of respiratory infection.
The Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) was calculated in relation to the Panther Fusion assay as the referenceresult, as shown in Table 8. The Aptima SARSCoV-2 assay showed positive and negative agreements of 100% and 98.2%, respectively.
Nasopharyngeal wash/aspirate, nasal aspirates, nasal swabs (self collected under supervision of, or healthcare provider-collected) and mid-turbinate nasal swabs are acceptable specimens to test f or viral respiratory inf ections. However, performance with these specimen types has not been specifically evaluated with the Aptima SARS-CoV-2 assay.
Table 8: Aptima SARS-CoV-2 Clinical Agreement
Aptima SARS-CoV-2 Assay
Po s i ti v e Neg ati v e
Panther Fusion SARS-CoV-2 Assay
Po s i ti v e
Neg ati v e
50
1
0
54
Overall Agreement: (95% CI): 99.0% (94.8% 99.8%) Positive Percent Agreement: (95% CI): 100% (92.9% 100%) Negative Percent Agreement: (95% CI): 98.2% (90.4% 99.7%)
Clinical Performance with Contrived Panel
The clinical perf ormance of the Aptima SARS-CoV-2 assay using the Aptima Specimen Transf er tube specimen preparation workflow was evaluated by testing contrived specimens. For the study, a panel of 115 remnant clinical nasopharyngeal specimens was tested using both the Panther Fusion Specimen Lysis Tube (Specimen Lysis Tube) and Aptima Specimen Transf er tube workflows. All specimens were collected from US patients with signs and symptoms of respiratory inf ection. The panel consisted of 65 SARS-CoV-2 positive and 50 SARS-CoV-2 negative specimens. Of the 65 positive specimens, 40 were at concentrations 0.5-2x LoD and 25 were at concentrations 3-5x LoD using inactivated cultured SARS-CoV-2 virus (USA-QA1/2020; BEI Resources; NR-52281) as the target. Due to limitations in available clinical specimens, reduced specimen/media volumes were utilized, while maintaining the Aptima Specimen Transf er workflow ratio of 1 mL specimen into 2.9 mL STM.
The Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for both specimen preparation workflows were calculated in relation to the expected result of the contrived specimen panel, as shown in Table 9 for the Specimen Lysis Tube and Table 10 for the Aptima Specimen Transfer Tube. Detection characteristics for the contrived specimens were calculated by target concentration, as shown in Table 11, in addition to a breakdown of the positive specimens by concentration in relation to the assay LoD. Both specimen preparation workflows showed 100% agreement for the evaluated panels.
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Clinical Performance
Aptima® SARS-CoV-2
Table 9: Performance of the Specimen Lysis Tube Workflow Relative to Expected Results
Expected Result
Specimen
Lysis Tube Result
Po s i ti v e Neg ati v e
To tal
Po s i ti v e 65 0 65
Neg ati v e 0 50 50
To tal 65 50 115
Overall Agreement: 100% (96.8% 100%) Positive Agreement: 100% (94.4% 100%) Negative Agreement: 100% (92.9% 100%)
Table 10: Performance of the Aptima Specimen Transfer Tube Workflow Relative to Expected Results
Expected Result
Aptima Specimen Transfer Result
Po s i ti v e Neg ati v e
Po s i ti v e 65 0
Neg ati v e 0 50
To tal 65 50
To tal
65
50
115
Overall Agreement: 100% (96.8% 100%) Positive Agreement: 100% (94.4% 100%) Negative Agreement: 100% (92.9% 100%)
Table 11: Detection Characteristics for Contrived Nasopharyngeal Swab Specimens
Aptima Specimen Transfer Sample Workflow Specimen Lysis Tube Sample Workflow
Target Conc.
n
n
%
Average St Dev
Valid Positive Positive kRLU kRLU
%CV
n Valid
n
% Average St Dev
Positive Positive kRLU kRLU
%CV
Neg
50
0
0
299
9.7 3.2
50
0
0
300 9.3 3.1
0.5x LoD 10
10
100 1050 208.5 19.9 10
10
100 1153 113.0 9.8
1.0x LoD 10
10
100 1176 102.1 8.7 10
10
100 1205 24.3 2.0
1.5x LoD 10
10
100 1222 31.6 2.6 10
10
100 1223 21.9 1.8
2.0x LoD 10
10
100 1225 22.6 1.8 10
10
100 1237 26.0 2.1
3.0x LoD 10
10
100 1228 13.6 1.1 10
10
100 1215 25.5 2.1
4.0x LoD 5
5
100 1238 16.7 1.4
5
5
100 1212 12.5 1.0
5.0x LoD 10
10
100 1237 18.2 1.5 10
10
100 1246 28.3 2.3
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Clinical Performance
Clinical Performance with Naturally Infected Positive Specimens
The clinical perf ormance of the Aptima SARS-CoV-2 assay using the Aptima Specimen Transf er (AST) tube specimen preparation workflow was evaluated in comparison to the Specimen Lysis Tube (SLT) workflow tested with both the Aptima and Panther Fusion SARS-CoV-2 assays. For the study, three dilutions of 15 unique SARS-CoV-2 positive nasopharyngeal swab specimens were prepared and processed using both workflows. SARS-CoV-2 samples were previously determined to be positive using a non-Hologic molecular assay.
The positive percent agreement between the Aptima SARS-CoV-2 assay using the AST tube and the SLT workflows were 97.5% (87.1% 99.6%) and 100% (91.0% 100%), respectively, when compared to the Panther Fusion SARS-CoV-2 assay using the SLT workflow as reference (Table 10). The positive percent agreement of the Aptima Specimen Transf er tube workflow was 95.0% (83.5% 98.6%) when compared to the SLT workflow as reference Table 12.
Table 12: Aptima Specimen Transfer Tube and Specimen Lysis Tube Workflow Comparison with Positive Specimens
AST workflow tested with the Aptima assay as compared to the SLT workflow tested with
the Panther Fusion assay
SLT workflow tested with the Aptima assay as compared to the
SLT workflow tested with the Panther Fusion assay
AST workflow tested with the Aptima assay as compared to the
SLT workflow tested with the Aptima assay
N Positive N Negative
N Total % Agreement
39 11 40 97.5% (87.1% - 99.6%)
39 0 39 100% (91.0% - 100%)
38 22 40 95.0% (83.5% - 98.6%)
1 Specimen was negative in the AST workflow tested with the Aptima assay and positive in the SLT workflow tested with the Panther Fusion assay. The same specimen was also positive in the SLT workflow tested with the Aptima assay. 2 Specimens were negative in the AST workflow tested with the Aptima assay and positive with the SLT workflow tested with the Aptima assay. One of these specimens was positive with the SLT workflow tested with the Panther Fusion assay and the other was negative.
Uncapped Workflow Clinical Performance
The clinical perf ormance of the Aptima SARS-CoV-2 assay using the uncapped tube workflow in comparison to the capped tube workflow was evaluated using natural clinical specimens. The evaluation included testing 200 SARS-CoV-2 negative, and 50 SARS-CoV-2 positive specimens. Two test samples were prepared for each specimen, one for the capped tube workflow and one for the uncapped tube workflow.
The observed Positive Percent Agreement (PPA) between specimens tested using the uncapped tube workflow as compared to the same specimens tested using the capped workflow was 98.0% (89.7% - 99.7%). The Negative Percent Agreement (NPA) was 100% (98.1% - 100%). Refer to Table 13.
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Clinical Performance
Aptima® SARS-CoV-2
Table 13: Uncapped Clinical Agreement to Capped Results
Capped Results
Uncapped Results
Po s i ti v e Neg ati v e
Po s i ti v e 50 1
Neg ati v e 0
199
To tal 50 200
To tal
51
199
250
Overall Agreement: 99.6% (97.8% 99.9%) Positive Agreement: 98.0% (89.7% 99.7%) Negative Agreement: 100% (98.1% 100%)
Clinical Performance of Pooling up to 5 Specimens Prior to Testing
The clinical perf ormance of the Aptima SARS-CoV-2 assay was evaluated in pools consisting of up to 5 specimens. For the study, a pool size of 5 specimens was evaluated and included positive and negative specimen pools. Each positive specimen pool consisted of one positive specimen with the remaining specimens being negative, whereas the negative specimen pools consisted only of negative specimens. For the study, 50 positive and 20 negative specimen pools were evaluated. The positive specimens used in the study covered the detectable range of the assay and included low positive specimens. Specimens for inclusion in the clinical performance of pooling study were chosen based on Ct results obtained with the Panther Fusion SARS-CoV-2 assay. The Panther Fusion SARS-CoV-2 assay was used f or this purpose because the Panther Fusion SARS-CoV-2 and Aptima SARS-CoV-2 assays have the same LoD when evaluated with the FDA ref erence panel (i.e., 600 NDU/mL). Low positive specimens included in the study were def ined as having a Ct value within 1-2 Ct of the LoD of the Panther Fusion SARS-CoV-2 assay. Both the pooled and individual specimens were evaluated with the Aptima SARS-CoV-2 assay.
The Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) were calculated in relation to the expected (individual) result, as shown in Table 14. All evaluated positive specimens yielded a positive result in the pool. Since the kRLU values f or the Aptima assay do not correspond to target concentration, signal and in silico sensitivity analysis was not perf ormed.
Table 14: Individual and Pooled Specimen Agreement with a Pool Size of 5
Pool of 5 Result
Po s i ti v e Neg ati v e
To tal
Individual Specimen Result
Po s i ti v e
Neg ati v e
50
0
0
20
50
20
To tal 50 20 70
Overall Agreement: 100% (94.8% 100.0%) Positive Agreement: 100% (92.9% 100.0%) Negative Agreement: 100% (83.9% 100.0%)
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Bibliography
Bibliography
1. World Health Organization. Q&A on coronaviruses (COVID-19). March 9, 2020. World Health Organization Web site https://www.who.int/ news-room/q-a-detail/q-a-coronaviruses. Accessed March 10, 2020.
2. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. Accessed June 17,2020.
3. Centers for Disease Control and Prevention. Coronavirus Disease 2019-(COVID-19) in the U.S. Updated March 10, 2020. Centers for Disease Control and Prevention Web site https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html. Accessed March 10, 2020.
4. Centers for Disease Control and Prevention. Coronavirus Disease 2019 Information for Travel. Page last reviewed March 8, 2020. Centers for Disease Control and Prevention Web site https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html. Accessed March 10, 2020.
5. Centers for Disease Control and Prevention. Coronavirus Disease 2019-(COVID-19) Situation Summary. Updated March 9, 2020. Centers for Disease Control and Prevention Web site https://www.cdc.gov/coronavirus/2019-ncov/summary.html. Accessed March 10, 2020.
6. Clinical & Laboratory Standards Institute. Document M29 Protection of Laboratory Workers from Occupationally Acquired Infections. CLSI Web site https://clsi.org/standards/products/microbiology/documents/m29/. Accessed September 2017.
Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 USA
Customer Support: +1 800 442 9892 customersupport@hologic.com
Technical Support: +1 888 484 4747 molecularsupport@hologic.com
For more contact information visit www.hologic.com.
Hologic, Aptima, Panther, and Panther Fusion are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
All other trademarks that may appear in this package insert are the property of their respective owners.
This product may be covered by one or more U.S. patents identified at www.hologic.com/patents.
©2021 Hologic, Inc. All rights reserved.
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Appendix A: Specimen Pooling Implementation and Monitoring Guidelines Aptima®SARS-CoV-2
Appendix A: Specimen Pooling Implementation and Monitoring Guidelines
Before Implementation of Pooling: Determine Appropriate Pool Size
Before a pooling strategy is implemented, a laboratory should determine the appropriate pool size based on percent positivity rate and desired testing efficiency. The Aptima SARS-CoV-2 assay has been validated for n-sample pool sizes up to five samples per pool.
If historical laboratory data for individual specimens is available:
· If historical data for individual specimens from the previous 7-10* days is available, estimate the percent positivity rate (Pindividual) based on individual results. (Pindividual) = (Number of positive specimen over chosen date range ÷ Total number of specimen tested over chosen date range)*100.
· Using the calculated Pindividual and Table 15, identify the appropriate n number of samples to pool.
· If Pindividual is less than 5%, the maximum pool size validated, (n=5), should be selected to maximize the efficiencyof specimen pooling. Pooling with greater than 5 samples has not been validated and should not be performed.
· If Pindividual is greater than 25%, Dorfman pooling of patient specimens is not efficient and should not be implemented.
If historical laboratory data for individual specimens is unavailable:
· If historical data from the previous 7-10* days is unavailable, 5, 4, or 3-specimen pooling may still implemented as the Aptima SARS-CoV-2 assay has been validated for 5-specimen pooling.
· Note: Without calculating Pindividual the pooling size implemented may not maximize pooling efficiency.
Table 15: Result Interpretation
P, percent of positive subjects in the tested population
nmaxefficiency
(n corresponding to the maximal efficiency)
5%-6%
5
7%-12%
4
13%-25%
3
Efficiency of n-sample pooling
(a maximum increase in the number of tested patients when Dorfman n-pooling strategy used)
2.15-2.35
1.54-1.99
1.10-1.48
Because a positive pool requires individual retesting of each sample in the pool, the efficiency of any pooling strategy depends on the positivity rate. The efficiency (F) of n-sample pooling for positivity rate (P) can be calculated with the following formula F=1/(1+1/n-(1-P)n). The efficiency (F) indicates how many more patients can be tested with n-sample pools compared to individual testing. For example, a 5-sample pooling strategy increases the number of tested patients by
2.15 times for positivity rate P of 6% (F=2.15). At F=2.15, 1,000 tests can on average cover testing of 2,150 patients.
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Aptima® SARS-CoV-2 Appendix A: Specimen Pooling Implementation and Monitoring Guidelines
Implementation of Pooling See above section titled Specimen Pooling: Preparing Samples for Pooling and perform pooling procedure as outlined.
After Implementation of Pooling: Ongoing Monitoring of Pooling Strategy
If historical laboratory data for individual specimens is available:
· Af ter implementing a pooling strategy, evaluate the perf ormance of pooled testing by comparing the percent positivity rate of pooled testing to that of individual testing.
· Calculate the percent positivity rate among patient specimens during specimen pooling (Ppools) on a daily basis using a moving average of the data f rom the previous 7-10* days of testing. (Ppools) = (Number of patient specimens with a positive result as determined by individual specimen reflex testing of positive pools over chosen date range ÷ Total number of patient specimens tested in pools over chosen date range)*100
· Compare Ppools to Pindividual. If Ppools is less than 85% of Pindividual. (Ppools < 0.85 X Pindividual), it is recommended that the pool size be reassessed and adjusted to maximize pooling efficiency (if necessary), according to the criteria in Table 15.
· Toensure maximum pooling efficiency, it is recommended that nmaxeffiency be reaccessed periodically while sample pooling is implemented by the laboratory.
If historical laboratory data for individual specimens is unavailable:
· After initiating a pooling strategy, evaluate the performance of pooled testing by calculating the initial percent positivity rate for pooled specimens (Ppools-initial). (Ppoolsinitial is the percent positivity rate f or pooled specimens f or the first 7-10* days of pooled testing.
· Calculate the initial percent positivity rate for individual specimens from pool testing (Ppools-initial) from the first 7-10* days of testing. Ppools-initial = (Number of patient specimens with a positive result as determined by individual specimen reflex testing of positive pools in first 7-10* days ÷ Total number of patient specimens tested in pools in the first 7-10* days)*100
· If Ppools-initial is greater than 25%, pooling of patient specimens is not efficient and should be discontinued until the percent positivity rate decreases.
· If Ppools-initial is less than or equal to 25%, pooling of patient specimens can be continued.
· Continue to monitor pooling strategy by calculating the percent positivity rate among patient specimens during specimen poling (Ppools-x) for subsequent 7-10* day periods. (Ppools-x) should be updated daily using a moving average.
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Appendix A: Specimen Pooling Implementation and Monitoring Guidelines Aptima®SARS-CoV-2
· Compare Ppools-x to Ppools-initial. If Ppools-x is less than 90% of Ppools-initial (Ppools-x <0.90 X Ppools-initial), it is recommended that the pool size be reassessed and potentially adjusted to maximize pooling efficiency.
· Toensure maximum pooling efficiency, it is recommended that nmaxefficiency be reassessed periodically while sample pooling is implemented by the laboratory.
*7-10 days is recommended f or calculating Pindividual, Ppools, Ppools-initial, and Ppools-x. Laboratories should determine if 7-10 days is appropriate by taking into consideration laboratory testing volume and percent positivity. If the number of individual or pooled positive results collected during a given time f rame is less than 10, Pindividual, Ppools, Ppools-initial, and Ppools-x may not be representative of the percent positivity in the testing population. Consider extending the data collection time period to increase the number of positives evaluated.
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Aptima®
Hologic® Direct Load Capture Cap Collection Kit -- CLASSIQSwabs®
For Emergency Use Authorization (EUA) Only Rx only
Intended Use
The Hologic® Direct Load Capture Cap Collection Kit CLASSIQSwabs® is intended to be used for clinician collection of throat and nasal swab specimens and patient collection of nasal swab specimens in a health care setting for testing with the Aptima® SARS-CoV-2 assay to detect the presence of RNA for SARS-CoV-2. The Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs has not been evaluated for home use.
Materials Provided
100 Hologic Direct Load Capture Cap Collection Kit--CLASSIQSwabs® (Cat. No. PRD-06951)
Each kit contains:
Component
Swab Direct Load Capture Cap tube
Quantity
1 1
Description
Individually wrapped, sterile swab Tube containing Specimen Transport Medium (STM), 2.9 mL
Warnings and Precautions
A. Wash hands with soap before opening collection kit.
B. Use the provided swab only. Failure to use the provided swab may invalidate the test results.
C. Do not use if the swab is visibly damaged (i.e., if the swab tip or shaf t is broken).
D. Do not bend or shape the swab bef ore collection. Do not use excessive force, pressure or bending when collecting the specimen as this may result in accidental breakage of the swab.
E. Fiber adhesion to the shaf t has been tested f or instantaneous specimen collection: longer contact between the swab and the collection area may cause f iber detachment.
F. Do not apply the specimen transport medium directly to skin or mucous membranes or take internally.
G. Specimens may be infectious. Use Universal Precautions when handling specimens. Only personnel adequately trained in handling inf ectious materials should be permitted to handle specimens.
H. This product has not been FDA cleared or approved but has been authorized f or emergency use by FDA under an EUA f or use by authorized laboratories.
I. This product has been authorized only f or the detection of nucleic acid f rom SARS-CoV-2 and not f or any other viruses or pathogens.
Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs®
1
AW-23536-001 Rev. 002
Hologic®
Kit Storage Requirements
J. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics f or detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
K. Take care to avoid cross-contamination during the specimen handling steps. Specimens can contain extremely high levels of pathogens. Ensure that specimen containers do not contact one another, and discard used materials without passing over the containers. If gloves come in contact with specimen, change gloves to avoid cross-contamination.
L. If the contents of the transport tube are spilled at any time during the collection procedure, use a new Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs. Failure to use a new kit may invalidate the test results.
M. Maintain proper storage conditions during specimen shipping to ensure the integrity of the specimen. Specimen stability under shipping conditions other than those recommended has not been evaluated.
N. Do not use the kit af ter its expiration date to collect specimens.
Kit Storage Requirements
Store collection kit at room temperature (15°C to 30°C).
Direct Load Capture Cap Collection Kit CLASSIQSwabs Performance
The Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs contains the same media and volume as the Aptima Multitest Specimen Collection Kit. Performance data for the Multitest Specimen Collection Kit was used to support the Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs. Assay performance characteristics using the Multitest swab specimens are provided in the Aptima SARSCoV-2 package insert, which may be ref erenced online at www.hologic.com.
When collecting multiple specimens f rom the same patient, the tube label includes a f ield to record each unique specimen source.
Throat Swab Specimens Collection and Handling
Instructions for throat swab specimen collection (clinician collection only):
1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the sof t tip is touched, the swab is laid down, or the swab is dropped, use a new Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs.
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaf t below the score line.
3. Caref ully insert the swab into the throat ensuring contact with bilateral tonsils (if present) and the posterior pharyngeal wall, then withdraw the swab without touching the inside of the cheeks or tongue.
4. While holding the swab in the same hand, unscrew the cap f rom the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs.
5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
6. Caref ully break the swab shaf t at the score line against the side of the tube.
7. Immediately discard the top portion of the swab shaf t.
8. Tightly screw the cap onto the tube.
Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs®
2
AW-23536-001 Rev. 002
Hologic®
Nasal Swab Specimens Collection and Handling
Nasal Swab Specimens Collection and Handling
Note to Patient: If you have any questions about this procedure, please ask your healthcare provider.
Instructions for nasal swab specimen collection: clinician collection and patient self-collection
1. Wash hands with soap and water f or 30 seconds before starting. 2. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab
down. If the sof t tip is touched, the swab is laid down, or the swab is dropped, use a new Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs. 3. Hold the swab, placing your thumb and f orefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaf t below the score line.
4. Caref ully insert the swab into the f irst nostril until the swab tip is no longer visible, i.e. ½ to ¾ of an inch or 1.25 to 2 cm into the nostril. Rotate the swab with moderate pressure against as much of the wall of the nostril as possible in a large circular path inside the nose at least 4 times (approximately 10-15 seconds per nostril) against the nasal wall and remove f rom nostril.
Note: Simply twirling the swab against one part of the inside of the nose or leaving the swab in the nose f or 10-15 seconds, is not proper technique and may result in an insufficient sample.
5. Using the same swab, caref ully insert the swab into the second nostril until the swab tip is no longer visible, i.e. ½ to ¾ of an inch or 1.25 to 2 cm into the nostril. Rotate the swab with moderate pressure against as much of the wall of the nostril as possible in a large circular path inside the nose at least 4 times (approximately 10-15 seconds per nostril) and remove from nostril. Do not force the swab any further up and into nose at any point.
Note: You must collect the sample from both nostrils!
Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs®
3
AW-23536-001 Rev. 002
Hologic®
Specimen Transport and Storage
6. While holding the swab in the same hand, unscrew the cap f rom the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs.
Note to Patient: Inf orm your doctor or healthcare worker if liquid is spilled and a new kit is required.
Warning: If you come into contact with liquid from the tube, wash your hands with soap and water for 30 seconds.
7. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
8. Caref ully break the swab shaf t at the score line against the side of the tube. 9. Immediately discard the top portion of the swab shaf t. 10. Tightly screw the cap onto the tube.
Note to Patient: Return the collection kit to your doctor or healthcare worker.
Specimen Transport and Storage
Swab specimens are intended to be transported to the laboratory in the provided swab specimen transport medium and tube f or use with the Aptima SARS-CoV-2 assay. Refer to the Aptima SARS-CoV-2 assay package insert f or proper specimen storage conditions.
Note: Specimens must be shipped in accordance with applicable national and international regulations.
Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs®
4
AW-23536-001 Rev. 002
Hologic®
Limitations
Limitations
A. Use this collection kit only with the Aptima SARS-CoV-2 assay. Performance has not been established with other products.
B. Use appropriate personal protective equipment (PPE) when collecting and handling specimens f rom individuals suspected of being infected with SARS-CoV-2 as outlined in CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV)
C. The patient-collected Direct Load Tube Kit nasal swab application is limited to health care f acilities where support/counseling is available to explain the procedures and precautions.
Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 USA
Customer Support:
+1 800 442 9892 customersupport@hologic.com
Technical Support:
+1 888 484 4747 molecularsupport@hologic.com
For more contact inf ormation visit www.hologic.com.
Hologic, Aptima, and associated logos, are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
All other trademarks that may appear in this package insert are the property of their respective owners. This product may be covered by one or more U.S. patents identified at www.hologic.com/patents.
©2021 Hologic, Inc. All rights reserved. AW-23536 Rev. 002 2021-03
Hologic Direct Load Capture Cap Collection Kit CLASSIQSwabs®
5
AW-23536-001 Rev. 002
Hologic® Direct Load Tube Collection Kit
Aptima®
For Emergency Use Authorization (EUA) Only Rx only
Intended Use
The Hologic® Direct Load Tube Collection Kit is intended to be used f or clinician collection of throat and nasal swab specimens and patient collection of nasal swab specimens in a health care setting for testing with the Aptima SARS-CoV-2 assay to detect the presence of RNA for SARS-CoV-2. The Hologic Direct Load Tube Collection Kit has not been evaluated f or home use.
Materials Provided
100 Hologic Direct Load Tube Collection Kits (Cat. No. PRD-06997) Each kit contains:
Component
Swab Transport tube
Quantity
1 1
Warnings and Precautions
Description
Individually wrapped, sterile swab Tube containing Specimen Transport Medium (STM), 2.9 mL
A. Wash hands with soap before opening collection kit.
B. Use the provided swab only. Failure to use the provided swab may invalidate the test results.
C. Do not use if the swab is visibly damaged (i.e., if the swab tip or shaf t is broken).
D. Do not bend or shape the swab bef ore collection. Do not use excessive force, pressure or bending when collecting the specimen as this may result in accidental breakage of the swab.
E. Do not apply the specimen transport medium directly to skin or mucous membranes or take internally.
F. Specimens may be infectious. Use Universal Precautions when handling specimens. Only personnel adequately trained in handling inf ectious materials should be permitted to handle specimens.
G. This product has not been FDA cleared or approved but has been authorized f or emergency use by FDA under an EUA f or use by authorized laboratories.
H. This product has been authorized only f or the detection of nucleic acid f rom SARS-CoV-2 and not f or any other viruses or pathogens.
I. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Hologic Direct Load Tube Collection Kit
1
AW-18114-001 Rev. 001
Hologic®
Kit Storage Requirements
J. Take care to avoid cross-contamination during the specimen handling steps. Specimens can contain extremely high levels of pathogens. Ensure that specimen containers do not contact one another, and discard used materials without passing over the containers. If gloves come in contact with specimen, change gloves to avoid cross-contamination.
K. If the contents of the transport tube are spilled at any time during the collection procedure, use a new Hologic Direct Load Tube Collection Kit. Failure to use a new kit may invalidate the test results.
L. Maintain proper storage conditions during specimen shipping to ensure the integrity of the specimen. Specimen stability under shipping conditions other than those recommended has not been evaluated.
M. Do not use the kit af ter its expiration date to collect specimens.
Kit Storage Requirements
Store collection kit at room temperature (15°C to 30°C).
Direct Load Tube Collection Kit Performance
The Hologic Direct Load Tube Collection Kit contains the same media and volume as the Aptima Multitest Specimen Collection Kit. Perf ormance data f or the Multitest Specimen Collection Kit was used to support the Hologic Direct Load Tube Collection Kit. Assay performance characteristics using the Multitest swab specimens are provided in the Aptima SARS-CoV-2 package insert, which may be ref erenced online at www.hologic.com.
When collecting multiple specimens f rom the same patient, the tube label includes a f ield to record each unique specimen source.
Throat Swab Specimens Collection and Handling
Instructions for throat swab specimen collection (clinician collection only):
1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the sof t tip is touched, the swab is laid down, or the swab is dropped, use a new Hologic Direct Load Tube Collection Kit.
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaf t below the score line.
3. Caref ully insert the swab into the throat ensuring contact with bilateral tonsils (if present) and the posterior pharyngeal wall, then withdraw the swab without touching the inside of the cheeks or tongue.
4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Hologic Direct Load Tube Collection Kit.
5. Immediately place the swab into the transport tube so that the score line is at the top of the tube. 6. Caref ully break the swab shaf t at the score line against the side of the tube. 7. Immediately discard the top portion of the swab shaf t.
8. Tightly screw the cap onto the tube.
Hologic Direct Load Tube Collection Kit
2
AW-18114-001 Rev. 001
Hologic®
Nasal Swab Specimens Collection and Handling
Nasal Swab Specimens Collection and Handling
Note to Patient: If you have any questions about this procedure, please ask your healthcare provider. Instructions for nasal swab specimen collection: clinician collection and patient self-collection
1. Wash hands with soap and water f or 30 seconds before starting.
2. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the sof t tip is touched, the swab is laid down, or the swab is dropped, use a new Hologic Direct Load Tube Collection Kit.
3. Hold the swab, placing your thumb and f orefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaf t below the score line.
4. Caref ully insert the swab into the f irst nostril until the swab tip is no longer visible, i.e. ½ to ¾ of an inch or 1.25 to 2 cm into the nostril. Rotate the swab with moderate pressure against as much of the wall of the nostril as possible in a large circular path inside the nose at least 4 times (approximately 10-15 seconds per nostril) against the nasal wall and remove f rom nostril.
Note: Simply twirling the swab against one part of the inside of the nose or leaving the swab in the nose f or 10-15 seconds, is not proper technique and may result in an insufficient sample.
5. Using the same swab, caref ully insert the swab into the second nostril until the swab tip is no longer visible, i.e., ½ to ¾ of an inch into the nostril. Rotate the swab with moderate pressure against as much of the wall of the nostril as possible in a large circular path inside the nose at least 4 times (approximately 10-15 seconds per nostril) and remove f rom nostril. Do not force the swab any further up and into nose at any point.
Note: You must collect the sample from both nostrils!
Hologic Direct Load Tube Collection Kit
3
AW-18114-001 Rev. 001
Hologic®
Specimen Transport and Storage
6. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Hologic Direct Load Tube Collection Kit.
Note to Patient: Inf orm your doctor or healthcare worker if liquid is spilled and a new kit is required.
Warning: If you come into contact with liquid from the tube, wash your hands with soap and water for 30 seconds.
7. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
8. Caref ully break the swab shaf t at the score line against the side of the tube. 9. Immediately discard the top portion of the swab shaf t. 10. Tightly screw the cap onto the tube.
Note to Patient: Return the collection kit to your doctor or healthcare worker.
Specimen Transport and Storage
Swab specimens are intended to be transported to the laboratory in the provided swab specimen transport medium and tube for use with the Aptima SARS-CoV-2 assay. Ref er to the Aptima SARS-CoV-2 assay package insert f or proper specimen storage conditions. Note: Specimens must be shipped in accordance with applicable national and international regulations.
Hologic Direct Load Tube Collection Kit
4
AW-18114-001 Rev. 001
Hologic®
Limitations
Limitations
A. Use this collection kit only with the Aptima SARS-CoV-2 assay. Performance has not been established with other products.
B. Use appropriate personal protective equipment (PPE) when collecting and handling specimens f rom individuals suspected of being infected with SARS-CoV-2 as outlined in CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV).
C. The patient-collected Direct Load Tube Kit nasal swab application is limited to health care f acilities where support/counseling is available to explain the procedures and precautions.
Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 USA Customer Support: +1 800 442 9892
customersupport@hologic.com Technical Support: +1 888 484 4747
molecularsupport@hologic.com For more contact information visit www.hologic.com.
Hologic, Aptima, and associated logos, are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
All other trademarks that may appear in this package insert are the property of their respective owners.
This product may be covered by one or more U.S. patents identified at www.hologic.com/patents.
©2016-2021 Hologic, Inc. All rights reserved. AW-18114-001 Rev. 001 2021-03
Hologic Direct Load Tube Collection Kit
5
AW-18114-001 Rev. 001
AptimaTM
Hologic® Direct Load Capture Cap Collection Kit -- FLOQSwabsTM
US : For Emergency Use Authorization (EUA) Only
Intended Use
Rx only
The Hologic® Direct Load Capture Cap Collection Kit FLOQSwabsTM is intended to be used for clinician collection of mid-turbinate and nasopharyngeal (NP) swab specimens for testing with the Aptima SARS-CoV2 assay to detect the presence of RNA for SARS-CoV-2. The Hologic Direct Load Capture Cap Collection Kit FLOQSwabs has not been evaluated for home use.
Materials Provided
100 Hologic Direct Load Capture Cap Collection Kit--FLOQSwabsTM (Cat. No. PRD-06952)
Each kit contains:
Component
Swab Direct Load Capture Cap tube
Quantity
1 1
Description
Individually wrapped, sterile swab Tube containing Specimen Transport Medium (STM), 2.9 mL
Warnings and Precautions
A. Wash hands with soap before opening collection kit.
B. Use the provided swab only. Failure to use the provided swab may invalidate the test results.
C. Do not use if the swab is visibly damaged (i.e., if the swab tip or shaf t is broken).
D. Do not bend or shape the swab before collection. Do not use excessive force, pressure or bending when collecting the specimen as this may result in accidental breakage of the swab.
E. Fiber adhesion to the shaft has been tested for instantaneous specimen collection: longer contact between the swab and the collection area may cause fiber detachment.
F. Do not apply the specimen transport medium directly to skin or mucous membranes or take internally.
G. Specimens may be infectious. Use Universal Precautions when handling specimens. Only personnel adequately trained in handling infectious materials should be permitted to handle specimens.
H. This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
I. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2 and not for any other viruses or pathogens.
J. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics f or detection
Hologic Direct Load Capture Cap Collection Kit FLOQSwabsTM
1
AW-20232-001 Rev. 001
Hologic®
Kit Storage Requirements
and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
K. Take care to avoid cross-contamination during the specimen handling steps. Specimens can contain extremely high levels of pathogens. Ensure that specimen containers do not contact one another, and discard used materials without passing over the containers. If gloves come in contact with specimen, change gloves to avoid cross-contamination.
L. If the contents of the transport tube are spilled at any time during the collection procedure, use a new Hologic Direct Load Capture Cap Collection Kit FLOQSwabs. Failure to use a new kit may invalidate the test results.
M. Maintain proper storage conditions during specimen shipping to ensure the integrity of the specimen. Specimen stability under shipping conditions other than those recommended has not been evaluated.
N. Do not use the kit after its expiration date to collect specimens.
Kit Storage Requirements
Store collection kit at room temperature (15°C to 30°C).
Direct Load Capture Cap Collection Kit FLOQSwabsTM Performance
Assay performance characteristics for the types of specimens (e.g., NP swabs) collected with the Direct Load Capture Cap Collection Kit FLOQSwabs is provided in the Aptima SARS-CoV-2 package insert, which may be referenced online at www.hologic.com.
When collecting multiple specimens from the same patient, the tube label includes a field to record each unique specimen source.
Nasal Mid-Turbinate (NMT) Specimen Collection and Handling
Instructions for nasal mid-turbinate (NMT) swab specimen collection (clinician collection only):
1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Hologic Direct Load Capture Cap Collection Kit FLOQSwabs.
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
3. Caref ully insert the swab into the mid-turbinate region. Rotate the swab several times against nasal wall.
4. Remove swab, insert it into the other nostril and repeat the process.
5. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Hologic Direct Load Capture Cap Collection Kit. - FLOQSwabs.
6. Immediately place the swab into the transport tube so that the score line is at the top of the tube. 7. Caref ully break the swab shaf t at the score line against the side of the tube. 8. Immediately discard the top portion of the swab shaf t.
9. Tightly screw the cap onto the tube.
Hologic Direct Load Capture Cap Collection Kit FLOQSwabsTM
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AW-20232-001 Rev. 001
Hologic®
Nasopharyngeal SwabSpecimens Collection andHandling
Nasopharyngeal Swab Specimens Collection and Handling
Instructions for nasopharyngeal swab specimen collection (clinician collection only):
1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Hologic Direct Load Capture Cap Collection Kit FLOQSwabs.
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
3. Tilt patient's head back 70 degrees. Gently and slowly insert swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place f or several seconds to absorb secretions. Slowly remove swab while rotating it.**
Note: Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the swab is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril. 4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Hologic Direct Load Capture Cap Collection Kit. FLOQSwabs.
5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
6. Caref ully break the swab shaf t at the score line against the side of the tube.
7. Immediately discard the top portion of the swab shaf t.
8. Tightly screw the cap onto the tube.
Specimen Transport and Storage
Swab specimens are intended to be transported to the laboratory in the provided swab specimen transport medium and tube for use with the Aptima SARS-CoV-2 assay. Refer to the Aptima SARS-CoV-2 assay package insert for proper specimen storage conditions.
Note: Specimens must be shipped in accordance with applicable national and international regulations.
Limitations
A. Use this collection kit only with the Aptima SARS-CoV-2 assay. Performance has not been established with other products.
B. Use appropriate personal protective equipment (PPE) when collecting and handling specimens from individuals suspected of being infected with SARS-CoV-2 as outlined in CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV).
* https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html
Hologic Direct Load Capture Cap Collection Kit FLOQSwabsTM
3
AW-20232-001 Rev. 001
Hologic®
Limitations
Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 USA
UK Responsible Person: Hologic Ltd. Oaks Business Park, Crewe Road Wythenshawe, Manchester, M23 9HZ United Kingdom
For country-specific Technical Support and Customer Service email address and telephone number, visit www.hologic.com/support.
Hologic, Aptima, and associated logos, are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
FLOQSwabs is a trademark of Copan Italia S.P.A.
All other trademarks that may appear in this package insert are the property of their respective owners. This product may be covered by one or more U.S. patents identified at www.hologic.com/patents.
©2021 Hologic, Inc. All rights reserved. AW-20232 Rev. 001 2021-05
Hologic Direct Load Capture Cap Collection Kit FLOQSwabsTM
4
AW-20232-001 Rev. 001
Front
Aptima® SARS-CoV-2 Assay For the detection of RNA from SARS-CoV-2
US: For Use Under an Emergency Use Authorization (EUA) Only
This product may be covered by one or more U.S. patents identified at www.hologic.com/patents
Consult Package Insert for hazard information
The text in the box on this insert applies to US Customers only
Box 1 of 2:
Amplification Reagent (Nucleic Acids) 1 EA / Enzyme Reagent (Enzyme) 1 EA / Probe Reagent (Chemiluminescent
probes) 1 EA / Internal Control (Non-infectious nucleic acid in a buffered solution) 1 EA
Box 2 of 2:
Amplification Reconstitution Solution (Aqueous solution containing preservatives) 1 EA / Enzyme Reconstitution Solution (HEPES
buffered solution) 1 EA / Probe Reconstitution Solution (Succinate buffered solution) 1 EA / Selection Reagent (600 mM borate
buffered solution) 1 EA / Target Capture Reagent (Buffered salt solution containing solid-phase and capture oligomers) 1 EA /
Reconstitution Collars 1 Package / WARNING
Controls:
Non-infectious nucleic acid in a buffered solution 5 x 1.7 mL / Buffered solution 5 x 1.7 mL
AW-24906 Rev. 001
The text in the box on this insert applies to US Customers only
· Rx Only · For in vitro diagnostic use · For use under an Emergency Use Authorization (EUA) only · This product has not been FDA cleared or approved, but been authorized for emergency use by FDA under an EUA
for use by authorized laboratories. · This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses
or pathogens. · The emergency use of this product is only authorized for the duration of the declaration that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. · The current electronic instructions for use are available at https://www.hologic.com/package-inserts · To request a paper copy of the instructions for use free of charge, please contact Hologic Technical Support at molecularsupport@hologic.com
Aptima SARS-CoV-2 Assay SARS-CoV-2
Bulgarian
: (EUA)
, www.hologic.com/patents
The text in the box on this insert applies to US Customers only
1 2:
A ( ) 1 / E () 1 /
P ( ) 1 / B (
) 1
2 2:
P ( ) 1 EA / P
(HEPES ) 1 / P ( ) 1
/ P (600 mM ) 1 / P (
, ) 1 / 1 /
Controls: 5 1,7 mL /
Croatian
Aptima SARS-CoV-2 Assay Za detekciju RNA iz SARS-CoV-2
SAD: Za uporabu samo uz Odobrenje za hitnu uporabu (EUA) Ovaj je proizvod mozda zastien jednim ili vise americkih patenata identificiranih na www.hologic.com/patents Podatke o opasnostima potrazite u Umetku pakiranja The text in the box on this insert applies to US Customers only
Kutija 1 od 2:
Pojacani reagens (nukleinske kiseline) 1 EA / Enzimski reagens (enzim) 1 EA / Reagens sonde (hemiluminiscentne sonde) 1 EA / Interna kontrola (neinfektivna nukleinska kiselina u puferiranoj otopini) 1 EA
Kutija 2 od 2:
Otopina za pojacavanje rekonstitucije (vodena otopina koja sadrzi konzervanse) 1 EA / Otopina za rekonstituciju enzima (puferirana otopina HEPES) 1 EA / Otopina za rekonstitucijsku sondu (sukcinirana puferirana otopina) 1 EA / Selekcijski reagens (puferirana otopina 600 mM borata) 1 EA / Reagens za hvatanje (puferirana otopina soli koja se sastoji od cvrste faze i hvatajuih oligomera) 1 EA / Ovratnici za rekonstrukciju 1 paket / UPOZORENJE Kontrolni komplet:
Neinfektivna nukleinska kiselina u puferiranoj otopini 5 x 1,7 mL / Kontrolni komplet
Aptima SARS-CoV-2 Assay Pro detekci RNA viru SARS-CoV-2
Czech
USA: K pouzití pouze v rezimu povolení k nouzovému pouzití (Emergency Use Authorization EUA)
Tento produkt mze být chránn jedním nebo více patenty Spojených stát, které jsou uvedeny na webové stránce
www.hologic.com/patents
Pro informace o nebezpecnosti viz píbalový leták
The text in the box on this insert applies to US Customers only
Box 1 ze 2:
Amplifikacní reagencie (nukleová kyselina) 1 EA / Enzymová reagencie (enzym) 1 EA / Reagencie sondy (chemiluminis-
cencní sondy) 1 EA / Vnitní kontrola (neinfekcní nukleová kyselina v pufrovaném roztoku) 1 EA
Box 2 ze 2:
Rekonstitucní roztok pro amplifikacní reagencii (vodný roztok obsahující konzervanty) 1 EA / Rekonstitucní roztok pro enzymovou
reagencii (roztok pufrovaný HEPES) 1 EA / Rekonstitucní roztok pro reagencii sondy (roztok pufrovaný sukcinátem) 1 EA /
Selekcní reagencie (roztok pufrovaný 600mM boritanem) 1 EA / Reagencie pro záchyt cíle (pufrovaný solný rotok obsahující
pevnou fázi a záchytové oligomery) 1 EA / Rekonstitucní objímky 1 balení / VAROVÁNÍ
Sada kontrol:
Neinfekcní nukleová kyselina v pufrovaném roztoku 5 x 1,7 ml / Pufrovaný roztok 5 x 1,7 ml
Danish
Aptima SARS-CoV-2 Assay Til detektionen af RNA fra SARS-CoV-2 USA: Kun til brug under en Emergency Use Authorization (EUA), en særlig godkendelse til nødsituationer Dette produkt kan muligvis være dækket af et eller flere amerikanske patenter, der kan findes på www.hologic.com/patents Konsultér indlægssedlen for fareoplysninger The text in the box on this insert applies to US Customers only Æske 1 af 2 æsker: Amplifikationsreagens (nukleinsyrer) 1 EA / Enzymreagens (enzym) 1 EA / Probereagens (kemiluminiscerende prober) 1 EA / Intern kontrol (ikke-infektiøs nukleinsyre i en bufferopløsning) 1 EA Æske 2 af 2 æsker: Amplifikationsrekonstitutionsopløsning (vandopløsning, som indeholder konserveringsmidler) 1 EA / Enzymrekonstitutionsopløsning (HEPES bufferopløsning) 1 EA / Proberekonstitutionsopløsning (succinatbufferopløsning) 1 EA / Selektionsreagens (600 mM boratbufferopløsning) 1 EA / Target capture reagens (buffersaltopløsning, som indeholder fastfase og capture-oligomere) 1 EA / Rekonstitueringsmanchetter1 Pakke / ADVARSEL Kontrolkit: Ikke-infektiøs nukleinsyre i en bufferopløsning 5 x 1,7 ml / Bufferopløsning 5 x 1,7 ml
Dutch
Aptima SARS-CoV-2 Assay Voor de detectie van RNA uit SARS-CoV-2 VS: Alleen voor gebruik onder een Emergency Use Authorization (EUA) Dit product maakt mogelijk deel uit van een of meer Amerikaanse octrooien vermeld op www.hologic.com/patents Raadpleeg de bijsluiter voor informatie over gevaren The text in the box on this insert applies to US Customers only Doos 1 van 2: Amplificatiereagens (nucleïnezuren) 1 EA / Enzymreagens (enzym) 1 EA / Probereagens (chemiluminescente probes) 1 EA / Interne controle (niet-infectieuze nucleïnezuren in gebufferde oplossing) 1 EA Doos 2 van 2: Amplificatiereconstitutieoplossing (waterige oplossing met conserveermiddelen) 1 EA / Enzymreconstitutieoplossing (HEPES gebufferde oplossing) 1 EA / Probereconstitutieoplossing (met succinaat gebufferde oplossing) 1 EA / Selectiereagens (600 mM in boraat gebufferde oplossing) 1 EA / Target Capture Reagent (gebufferde zoutoplossing met vaste drager en capture-oligomeren 1 EA / Reconstitutiekraag 1 pakket / WAARSCHUWING Controlekit: Niet-infectieuze nucleïnezuren in gebufferde oplossing 5 x 1,7 mL / Gebufferde oplossing 5 x 1,7 mL
Estonian
Aptima SARS-CoV-2 Assay SARS-CoV-2 RNA määramiseks USA: kasutamiseks ainult erakorralise kasutamise volitusega (EUA) Seda toodet võib hõlmata üks või rohkem USA patentidest, mis on toodud veebilehel www.hologic.com/patents Ohutusteabe saamiseks lugege pakendi infolehte The text in the box on this insert applies to US Customers only Karp 1/2: Amplifikatsioonireaktiiv (nukleiinhapped) 1 tk / Ensüümreaktiiv (ensüüm) 1 tk / Sondi reaktiiv (kemoluminestsentssondid) 1 tk / Sisemine kontroll (mitteinfektsioosne nukleiinhape puhverlahuses) 1 tk Karp 2/2: Amplifikatsiooni rekonstitutsiooni lahus (vedel lahus, mis sisaldab säilitusaineid) 1 tk / Ensüümi rekonstitutsiooni lahus (HEPES-puhverlahus) 1 tk / Sondi rekonstitutsiooni lahus (suktsinaadi puhverlahus) 1 tk / Selektsiooni reaktiiv (600 mM boraadi puhverlahus) 1 tk / Sihtmärgi sidumise reaktiiv (Puhverdatud soolalahus, mis sisaldab tahkes faasis ja siduvaid oligomeere) 1 tk / Rekonstitutsiooni võrud 1 pakk / HOIATUS! Kontrollide komplekt: Mitteinfektsioosne nukleiinhape puhverlahuses 5 x 1,7 ml / Puhverlahus 5 x 1,7 ml
Finnish
Aptima SARS-CoV-2 Assay RNA:n havaitsemiseen SARS-CoV-2:sta USA: Saa käyttää vain hätäkäyttöluvalla (Emergency Use Authorization, EUA) Yksi tai useampi sivustossa www.hologic.com/patents mainituista US-patenteista voi kattaa tämän tuotteen. Katso haitallisuustiedot pakkausselosteesta The text in the box on this insert applies to US Customers only Pakkaus 1/2: Monistusreagenssi (nukleiinihapot) 1 kpl / Entsyymireagenssi (entsyymi) 1 kpl / Koetinreagenssi (kemiluminesenssikoettimet) 1 kpl / Sisäinen kontrolli (ei-infektoiva nukleiinihappo puskuroidussa liuoksessa) 1 kpl Pakkaus 2/2: Monistussekoitusliuos (säilytysaineita sisältävä vesiliuos) 1 kpl / Entsyymisekoitusliuos (HEPES-puskuroitu liuos) 1 kpl / Koetinsekoitusliuos (sukkinaattipuskuroitu liuos) 1 kpl / Valintareagenssi (600 mM boraattipuskuroitu liuos) 1 kpl / Kohteen poimintareagenssi (puskuroitu suolaliuos, joka sisältää kiinteän faasin ja poimintaoligomeereja) 1 kpl / Sekoitusvälikappaleet 1 pakkaus / VAROITUS Kontrollipakkaus: Ei-infektoiva nukleiinihappo puskuroidussa liuoksessa 5 x 1,7 ml / Puskuroitu liuos 5 x 1,7 ml
French - European
Aptima SARS-CoV-2 Assay Pour la détection de l'ARN du SARS-CoV-2 ÉTATS-UNIS : À n'utiliser que sous autorisation d'utilisation d'urgence (EUA) seulement Ce produit peut être protégé par un ou plusieurs brevets américains identifiés à l'adresse www.hologic.com/patents Consultez la notice pour plus d'informations sur les dangers The text in the box on this insert applies to US Customers only Boîte 1 de 2: Réactif d'amplification (acides nucléiques) 1 / Réactif enzymatique (enzyme) 1 / Réactif sonde (sondes chimiluminescentes) 1 /Contrôle interne (acide nucléique non infectieux dans une solution tampon) 1 Boîte 2 de 2: Solution de reconstitution pour amplification (solution aqueuse contenant des agents de conservation) 1 / Solution de reconstitution d'enzyme (solution tampon HEPES) 1 / Solution de reconstitution de sonde (solution tampon succinate) 1 / Réactif de sélection (solution tampon borate à 600 mM) 1 / Réactif de capture de cible A(solution saline tamponnée contenant des oligomères en phase solide et de capture) 1 / Collets de reconstitution 1 emballage / AVERTISSEMENT Kit de contrôles: Acide nucléique non infectieux dans une solution tamponnée 5 x 1,7 mL / Solution tamponnée 5 x 1,7 mL
German Aptima SARS-CoV-2 Assay Zum RNA-Nachweis von SARS-CoV-2
USA: Nur für die Anwendung gemäß einer Emergency Use Authorization (EUA) Dieses Produkt kann unter einem oder mehreren US-amerikanischen Patent(en) geschützt sein, die unter www.hologic.com/patents zu finden sind Gefahrenhinweise der Packungsbeilage entnehmen The text in the box on this insert applies to US Customers only Packung 1 von 2: Amplifikationsreagenz (Nukleinsäuren) 1 Stk / Enzymreagenz (Enzyme) 1 Stk / Sondenreagenz (Chemolumineszenzsonden) 1 Stk / Interne Kontrolle (nicht-infektiöse Nukleinsäure in gepufferter Lösung) 1 Stk Packung 2 von 2: Rekonstitutionslösung (Wässrige Lösung mit Konservierungsmitteln) Je 1 / Enzymrekonstitutionslösung (HEPES-gepufferte Lösung) 1 Stk / Sondenrekonstitutionslösung (sukzinatgepufferte Lösung) 1 Stk / Selektionsreagenz (600 mM boratgepufferte Lösung) 1 Stk / Target Capture-Reagenz (gepufferte Salzlösung mit Festphasen-und Fänger-Oligomeren) 1 Stk / Rekonstitutionsverbindungsstücke 1 Packung / WARNUNG Kontrollen-Kit: Nicht-infektiöse Nukleinsäure in gepufferter Lösung 5 x 1,7 mL / Gepufferte Lösung 5 x 1,7 mL
Greek Aptima SARS-CoV-2 Assay RNA SARS-CoV-2
...: (EUA) ... www.hologic.com/patents The text in the box on this insert applies to US Customers only 1 2: ( ) 1 EA / () 1 EA / ( ) 1 EA / ( ) 1 EA 2 2: A( ) 1 EA / ( HEPES) 1 EA / ( ) 1 EA / (600 mM ) 1 EA / ( ) 1 EA / 1 / : 5 x 1,7 mL / 5 x 1,7 mL
Back
Hungarian Aptima SARS-CoV-2 Assay A SARS-CoV-2 RNS kimutatására
Amerikai Egyesült Államok: Kizárólag sürgsségi használatra szóló engedély (Emergency Use Authorization, EUA) alapján használható. Ez a termék egy vagy több amerikai szabadalmi oltalom alá tartozik, amely szabadalmak megtalálhatók a www.hologic.com/patents oldalon A veszélyekkel kapcsolatos információkért olvassa el a terméktájékoztatót The text in the box on this insert applies to US Customers only 2/1. doboz: Amplifikációs reagens (nukleinsavak) 1 EA / Enzim reagens (enzim) 1 EA / Próba reagens (kemilumineszcens próbák) 1 EA / Bels kontroll (nem fertz nukleinsav pufferoldatban) 1 EA 2/2. doboz: Amplifikációs rekonstitúciós oldat (tartósítószert tartalmazó vizes oldat) 1 EA / Enzim rekonstitúciós oldat (HEPES pufferoldat) 1 EA / Próba rekonstitúciós oldat (szukcinát pufferoldat) 1 EA / Szelekciós reagens (600 mM borát pufferoldat) 1 EA / Célmegköt reagens (szilárd fázist és megköt oligomereket tartalmazó pufferelt sóoldat) 1 EA / Rekonstitúciós gallérok 1 csomag / FIGYELMEZTETÉS Kontroll készlet: Nem fertz nukleinsav pufferoldatban 5 x 1,7 ml / Pufferoldat 5 x 1,7 ml
Italian
Aptima SARS-CoV-2 Assay Per il rilevamento dell'RNA del SARS-CoV-2 Stati Uniti: utilizzo consentito con autorizzazione all'uso in emergenza (EUA) Questo prodotto potrebbe essere protetto da uno o più brevetti USA identificati nel sito www.hologic.com/patents Consultare il foglietto illustrativo per informazioni sui pericoli The text in the box on this insert applies to US Customers only Scatola 1 di 2: Reagente di amplificazione (acidi nucleici) 1 EA / Reagente enzimatico E (enzima) 1 EA / Reagente sonda (sonde chemiluminescenti) 1 EA / Controllo interno (acido nucleico non infettivo in soluzione tamponata) 1 EA Scatola 2 di 2: Soluzione di ricostituzione e amplificazione (soluzione acquosa contenente conservanti) 1 EA / Soluzione di ricostituzione enzimatica (soluzione tamponata HEPES) 1 EA / Soluzione di ricostituzione sonda (soluzione tampone succinato) 1 EA / Reagente di selezione (600 mM di soluzione tampone borato) 1 EA / Reagente di cattura del target (soluzione salina tamponata contenente oligomeri in fase solida di cattura) 1 EA / Collari di ricostituzione 1 confezione / AVVERTENZA Kit dei controlli: Acido nucleico non infettivo in soluzione tamponata 5 x 1,7 mL / Soluzione tamponata 5 x 1,7 mL
Latvian
Aptima SARS-CoV-2 Assay SARS-CoV-2 RNA noteiksanai ASV: lietosanai tikai rkrtas situcijs saska ar pilnvaru (EUA) Uz so izstrdjumu var attiekties viens vai vairki ASV patenti, kas nordti vietn www.hologic.com/patents Informciju par bstambu skatiet pavadlapi The text in the box on this insert applies to US Customers only 1. iepakojums no 2: Amplifikcijas reaents (nuklenskbes) 1 gab. viena vienba / Fermentu reaents (ferments) 1 gab. viena vienba / Zonzu reaents (hemiluminiscences zondes) 1 gab. viena vienba / Ieksj kontrole (neinficta nuklenskbe bufersdum) 1 gab. viena vienba 2. iepakojums no 2: Amplifikcijas sdinsanas sdums (dens sdums, kas satur konservantus) 1 gab. viena vienba / Fermentu sdinsanas sdums (HEPES buferts sdums) 1 gab. viena vienba / Zonzu sdinsanas sdums (sukcinta buferts sdums) 1 gab. viena vienba / Atlases reaents (600 mM borta buferts sdums) 1 gab. viena vienba / Mra saistsanas reaents (buferts sls sdums, kas satur cietvielu un saistmos oligomrus) 1 gab. viena vienba / Sdinsanas mansetes 1 iepakojums / BRDINJUMS Kontrou komplekts: Neinficta nuklenskbe bufersdum 5 x 1,7 ml / Bufersdums 5 x 1,7 ml
Lithuanian
Aptima SARS-CoV-2 Assay Aptikti SARS-CoV-2 viruso RNR JAV: Galima naudoti tik gavus leidim naudoti kritiniu atveju (angl. ,,Emergency Use Authorization" (EUA)) Siam produktui gali bti taikomas vienas ar daugiau JAV patent, juos galima rasti adresu www.hologic.com/patents Informacija apie pavojus pateikiama naudojimo instrukcijoje The text in the box on this insert applies to US Customers only 1 dz is 2: Amplifikacijos reagentas (nukleino rgstys) 1 vnt. / Fermentinis reagentas (fermentas) 1 vnt. / Zondavimo reagentas (chemiliuminescenciniai zondai) 1 vnt. / Vidin kontrol (neinfekcin nukleino rgstis tirpale) 1 vnt. 2 dz is 2: Amplifikacijos atskiedimo tirpalas (vandeninis tirpalas su konservantais) 1 vnt. / Ferment atskiedimo tirpalas (HEPES tirpalas) 1 vnt. / Zondo atskiedimo tirpalas (sukcinato irpalas) 1 vnt. / Selekcinis reagentas (600 mM boratinis tirpalas) 1 vnt. / Objekto sugavimo reagentas (druskos tirpalas su kietosios fazs ir sugavimo oligomerais) 1 vnt. / Atskiedimo ziedai 1 pakuot / SPJIMAS Kontrolinis rinkinys: Neinfekcin nukleino rgstis btirpale 5 x 1,7 ml / tirpalas 5 x 1,7 ml
Norwegian
Aptima SARS-CoV-2 Assay Til deteksjon av RNA fra SARS-CoV-2 USA: Kun til bruk med autorisasjon for nødbruk (EUA). Dette produktet kan være dekket av ett eller flere amerikanske patenter som identifiseres på www.hologic.com/patents Se pakningsvedlegget for å finne informasjon om farer. The text in the box on this insert applies to US Customers only Eske 1 av 2: Amplifiseringsreagens (nukleinsyrer) 1 EA / Enzymereagens (enzyme) 1 EA / Probereagens (kjemiluminiscente prober) 1 EA / Intern kontroll (ikke-infeksiøs nukleinsyre i en bufret løsning) 1 EA Eske 2 av 2: Amplifiseringrekonstitueringsløsning (vannholdig løsning som inneholder konserveringsmidler) 1 EA / Enzymerekonstitueringsløsning (HEPES-bufret løsning) 1 EA / Proberekonstitueringsløsning (suksinatbufret løsning) 1 EA / Seleksjonsreagens (600 mM boratbufret løsning) 1 EA / Målfangereagens (bufret saltløsning som inneholder fastfase og fangeoligomere) 1 EA / Rekonstitueringskrager 1 pakke / ADVARSEL Kontrollsett: Ikke-infeksiøs nukleinsyre i en bufret løsning 5 x 1,7 ml / Bufret løsning 5 x 1,7 ml
Polish Aptima SARS-CoV-2 Assay Do wykrywania RNA z/w SARS-CoV-2
USA: Do uytku wylcznie na podstawie pozwolenia na uytkowanie w trybie awaryjnym (EUA) Ten produkt moe by objty jednym lub kilkoma patentami amerykaskimi/USA okrelonymi na stronie www.hologic.com/patents. Informacje na temat zagroe znajduj si w ulotce dolczonej do opakowania. The text in the box on this insert applies to US Customers only Pudelko 1 z 2: Odczynnik do amplifikacji (kwasy nukleinowe) 1 EA / Odczynnik enzymatyczny (enzym) 1 EA / Odczynnik sondy (sondy chemiluminescencyjne) 1 EA / Kontrola Wewntrzna (niezakany kwas nukleinowy w roztworze zbuforowanym) 1 EA Pudelko 2 z 2: Roztwór do uzupelniania odczynnika amplifikacji (wodny roztwór zawierajcy rodki konserwujce) 1 EA / Roztwór do uzupelniania odczynnika enzymatycznego (roztwór zbuforowany HEPES) 1 EA / Roztwór do uzupelniania odczynnika sondy (roztwór zbuforowany bursztynianem) 1 EA / Odczynnik selekcji (600 mM roztwór zbuforowany boranem) 1 EA / Odczynnik celowego wychwytywania (zbuforowany roztwór soli zawierajcy faz stal i oligomery wychwytujce) 1 EA / Kolnierze do uzupelniania 1 Pakiet / OSTRZEENIE Zestaw kontrolny: Niezakany kwas nukleinowy w roztworze buforowym 5 x 1,7 mL / Roztwór zbuforowany 5 x 1,7 mL
Portuguese
Aptima SARS-CoV-2 Assay Para a deteção de RNA de SARS-CoV-2 Estados Unidos: Apenas para utilização ao abrigo da Autorização de utilização de emergência (EUA) Este produto pode estar abrangido por uma ou mais patentes nos Estados Unidos, as quais estão identificadas em www.hologic.com/patents The text in the box on this insert applies to US Customers only Caixa 1 de 2: Consulte o folheto informativo para obter informações sobre perigos. Reagente de amplificação (Ácidos nucleicos) 1 unidade / Reagente enzimático (Enzima) 1 unidade / Reagente de sonda (Sondas quimioluminescentes) / 1 unidade Controlo interno (Ácido nucleico não infecioso em solução tamponada) 1 unidade Caixa 2 de 2: Solução de reconstituição da amplificação (Solução aquosa com conservantes) 1 unidade / Solução de reconstituição enzimática (Solução tamponada com HEPES) 1 unidade / Solução de reconstituição de sonda (Solução tamponada com succinato) 1 unidade / Reagente de seleção (Solução tamponada com borato a 600 mM) 1 unidade / Reagente de captura do alvo (Solução salina tamponada com fase sólida e oligómeros de captura) 1 unidade / Aros de reconstituição 1 embalagem / ADVERTÊNCIA Kit de controlos: Ácido nucleico não infecioso em solução tamponada 5 x 1,7 ml / Solução tamponada 5 x 1,7 ml
Romanian
Aptima SARS-CoV-2 Assay Pentru detectarea ARN-ului din SARS-CoV-2 SUA: Pentru utilizare doar cu autorizaie de utilizare de urgen (EUA) Acest produs poate fi vizat de unul sau mai multe brevete din SUA identificate la www.hologic.com/patents Consultai prospectul din pachet pentru informaii despre pericole. The text in the box on this insert applies to US Customers only Cutia 1 din 2: Reactiv de amplificare (acizi nucleici) 1 flacon / Reactiv enzimatic (enzim) 1 flacon / Reactiv al sondei (sonde chemiluminiscente) 1 flacon / Control intern (acid nucleic neinfecios în soluie tamponat) 1 flacon Cutia 2 din 2: Soluie de reconstituire amplificare (soluie apoas coninând conservani) 1 flacon / Soluie de reconstituire enzimatic (soluie tamponat HEPES) 1 flacon / Soluie de reconstituire a probei (soluie tamponat de succinat) 1 flacon / Reactiv de selectare (soluie tamponat borat 600 mM) 1 flacon / Reactiv de captur a intei (soluie salin tamponat coninând faza solid i oligomeri de captur) 1 flacon / Coliere reconstituire 1 pachet / AVERTSMENT Kit de control: Acid nucleic neinfecios în soluie tamponat 5 x 1,7 mL / Soluie tamponat 5 x 1,7 mL
Slovak
Aptima SARS-CoV-2 Assay Na detekciu RNA SARS-CoV-2 USA: Na pouzitie výhradne pod Schválením pre núdzové pouzitie (EUA) Tento produkt môze by chránený jedným alebo viacerými patentami USA uvedenými na stránkach www.hologic.com/patents Informácie o rizikách nájdete v príbalovej informácii. The text in the box on this insert applies to US Customers only Box 1 z 2: Amplifikacné cinidlo (nukleové kyseliny) 1 EA / Enzymatické cinidlo (Enzyme) 1 EA / Sondové cinidlo (chemiluminiscencné sondy) 1 EA / Interná kontrola (neinfekcná nukleová kyselina v pufrovanom roztoku) 1 EA Box 2 z 2: Amplifikacný roztok na rekonstitúciu (vodný roztok obsahujúci stabilizátory) 1 EA / Roztok na rekonstitúciu enzýmu (roztok pufrovaný HEPES) 1 EA / Roztok na rekonstitúciu sondy (Succinate buffered solution) 1 EA / Výberové cinidlo (600 mM roztoku pufrovaného borátom) 1 EA / Cinidlo na cieový záchyt (pufrovaný soný roztok obsahujúci oligoméry pevnej fáze a zachytávacie oligoméry) 1 EA / Rekonstitucné objímky 1 balenie / VAROVANIE Súprava kontrol: Neinfekcná nukleová kyselina v pufrovanom roztoku 5 x 1,7 ml / Pufrovaný roztok 5 x 1,7 ml
Slovene
Aptima SARS-CoV-2 Assay Za odkrivanje RNA v SARS-CoV-2 ZDA: Za uporabo samo ob odobritvi Emergency Use Authorization (EUA) Ta izdelek morda krije eden ali vec patentov ZDA, ki so navedeni na www.hologic.com/patents Za informacije glede nevarnosti glejte navodila, prilozena pakiranju. The text in the box on this insert applies to US Customers only Skatla 1 od 2: Amplifikacijski reagent (nukleinske kisline) 1 EA / Encimski reagent (encim) 1 EA / Reagent z sonde (kemoluminiscentne sonde) 1 EA / Notranja kontrola (nenalezljive nukleinske kisline v puferirani raztopini) 1 EA Skatla 2 od 2: Amplifikacijska rekonstitucijska raztopina (vodna raztopina, ki vsebuje konzervanse) 1 EA / Encimska rekonstitucijska raztopina (raztopina s pufrom HEPES) 1 EA / Rekonstitucijska raztopina za sonde (raztopina s sukcinatnim pufrom) 1 EA / Izbirni reagent (raztopina s 600 mM boratnega pufra) 1 EA / Reagent za ciljno zajemanje (puferirana solna raztopina, ki vsebuje oligomere v trdni fazi in oligomere za zajemanje) 1 EA / Rekonstitucijski obrocki 1 paket / OPOZORILO Komplet kontrol: Nenalezljiva nukleinska kislina v puferirani raztopini 5 x 1,7 ml / Puferirana raztopina 5 x 1,7 ml
Spanish - Universal
Aptima SARS-CoV-2 Assay Para la detección del RNA de SARS-CoV-2 EE. UU.: Para uso exclusivo bajo una autorización de uso de emergencia (EUA) Este producto puede estar cubierto por una o más patentes estadounidenses identificadas en www.hologic.com/patents Consulte el prospecto para obtener la información sobre riesgos The text in the box on this insert applies to US Customers only Caja 1 de 2: Reactivo de amplificación (ácidos nucleicos), 1 ud / Reactivo enzimático (enzima), 1 ud / Reactivo de sonda (sondas quimioluminiscentes), 1 ud / Control interno (ácido nucleico no infeccioso en una solución de tampón), 1 ud Caja 2 de 2: Solución de reconstitución de amplificación (solución acuosa con conservantes), 1 ud / Solución de reconstitución enzimática (solución de tampón HEPES), 1 ud / Solución de reconstitución de sonda (solución de tampón succinato), 1 ud / Reactivo de selección (600 mM de solución de tampón de borato), 1 ud / Reactivo de captura (solución salina de tampón con fase sólida y oligómeros de captura), 1 ud / Collares de reconstitución, 1 paquete / ADVERTENCIA Kit de controles: Ácido nucleico no infeccioso en una solución de tampón, 5 x 1,7 mL / Solución de tampón, 5 x 1,7 mL
Swedish
Aptima SARS-CoV-2 Assay För detektering av RNA från SARS-CoV-2 USA: Endast för användning genom Emergency Use Authorization (EUA) (särskild nöddispens) Denna produkt kan täckas av ett eller fler amerikanska patent som anges på www.hologic.com/patents Se bipacksedeln för information om riskbedömning The text in the box on this insert applies to US Customers only Box 1 av 2: Amplification Reagent (nukleinsyror) 1 st / Enzyme Reagent (enzym) 1 st / Probe Reagent (kemiluminescenta prober) 1 st / Internal Control (icke smittförande nukleinsyra i buffrad lösning) 1 st Box 2 av 2: Amplification Reconstitution Solution (vattenbaserad med konserveringsmedel) 1 st / Enzyme Reconstitution Solution (buffrad HEPES-lösning) 1 st / Probe Reconstitution Solution (buffrad succinatlösning) 1 st / Selection Reagent (600 mM buffrad boratlösning) 1 st / Target Capture Reagent (buffrad saltlösning med solida partiklar och oligonukleotider) 1 st / Rekonstitueringskragar 1 förpackning / VARNING Kontroller: Icke smittförande nukleinsyra i buffrad lösning 5 x 1,7 mL / Buffrad lösning 5 x 1,7 mL
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