COVID-19 Research and Diagnostic Tools - BioServUK
Datasheet for BioServ models including: All-in-One Rapid COVID-19 Antigaen Saliva Pen
COVID-19 Antigen Rapid Test Pen (Saliva) (Pack of 20) BSV-COV-2PEN20 | Falcon Business Supplies
V2.1 Fact Sheet All-in-One Rapid COVID-19 ~30) before use. Antigen Saliva Pen WORLD'S FIRST `NO-SPIT' ORAL SWAB ANTIGEN RAPID TEST NO SET-UP REQUIRED NO EQUIPMENT RESULTS AFTER 15 MINS SAMPLE TYPE: SALIVA SENSITIVITY 100% aviruses belong to the genus. COVID Background The New Rapid ResponseTM COVID-19 Saliva Pen is the world's first `No-Spit' oral swab rapid antigen test. Designed for convenience, the compact test offers results for individuals suspected of COVID-19 in just 15 minutes, without any set-up or equipment! Extraction Buffer Cap Tip of Saliva Collection Pen (inserted into mouth) Saliva Collection Pen Test Control Line Line Sealed Buffer Target Customers Plastic Guard Essential Businesses: Production and manufacturing sites, logistics, customer facing employees, residential delivery, public transport employees, private hire companies, border control facilities. Health Care: Physical and occupational health, therapists, GP practices, Residential care homes, visiting nurses. Travel: International and domestic travel. Education: Colleges, universities, private and public schools, boarding schools, school support staff. Hospitality and Recreation: Service and bar staff, hotel staff and guests, airline and airport staff, sports teams. Performance Sensitivity: Specificity 100% 100% Estimated LOD: 31 TCID50/ml Storage: 2-30°C 8mm Distributed by: info@bioservuk.com www.bioservuk.com Test Strip ". 12cm C" r 18mm V2.1 Fact Sheet~30~)3b0e All-in-One Rapid COVID-19 Antigen Saliva Pen How to Use it oronavoirrounsaevsirbueselosngbeltongthetothgeenusg. eCnuOsV. ICDOVID Test Procedure ~30) before use. 1. Open the pouch and remove the Saliva Collection Pen and Extraction Buffer Cap from the packaging. Label the Saliva Collection Pen with patient identification. For best results, the assay should be performed within two hours. 1. ge2n.us.CcolCellaOercVttihnIDrgoatht,ethsaemn pcoleusg. h deeply four times with mouth closed before 3. Remove the plastic guard from the tip of the Saliva Collection Pen. 4. Place the Saliva Collection Pen in the mouth above the tongue. Hold in place for 2 minutes. 5. Remove the Saliva Collection Pen from the patient's mouth. Holding the Saliva Collection Pen vertically, place it into the extraction buffer Cap. Press down to break the seal of the Extraction Buffer Cap, which will release the buffer solution. 3. 6. Start the timer immediately after breaking the seal. Read the results at 15 minutes. 2. 2 Minutes 4. 15 Minutes Result Interpretation Pen 5. Tip Positive: Two coloured bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). Negative: Only one coloured band appears, in the control region (C). No apparent coloured band appears in the test region (T). Invalid: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. Note: 1. The colour intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of colour in the test region should be considered positive. Note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen. 2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure. This test is intended for professional use only. For more information please refer to product insert *NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of SARS-CoV-2 antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. C" r Distributed by: info@bioservuk.com www.bioservuk.com COVID-19 Antigen Saliva Test Kit Product Insert COV-2PEN, COV-2PEN1, COV-2PEN20 INTENDED USE The Rapid Response® COVID-19 Antigen Saliva Test Pen Kit is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from saliva samples. This test is intended for professional use only. SUMMARY AND EXPLANATION The novel coronaviruses belong to the genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, patients infected by the novel coronavirus are the main source of infection. Asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are found in a few cases. PRINCIPLE The Rapid Response® COVID-19 Antigen Saliva Test Kit detects SARS-CoV-2 viral antigens through visual interpretation of colour development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to coloured particles are immobilized on the conjugated pad. A sample is added to the Extraction Buffer which is optimized to release the SARS-CoV-2 antigens from specimen. During testing, target antigens, if present in the saliva samples, will be released into the Extraction Buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to coloured particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess coloured particles are captured at the internal control zone. The presence of a coloured band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A coloured band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working. MATERIALS Materials Provided · Individually packaged Saliva Collection Pen with Test Strip · Individually packaged Extraction Buffer Cap · Product Insert Materials Required but Not provided · Clock, timer, or stopwatch PRECAUTIONS · For in vitro Diagnostic Use Only. · Read the Package Insert prior to use. Directions should be read and followed carefully. · Do not use kit or components beyond the expiration date. · DO NOT eat, drink, smoke, brush teeth or chew gum for 30 minutes before collecting saliva. · The device contains material of animal origin and should be handled as a potential biohazard. Do not use if pouch is damaged or open. · Test devices are packaged in foil pouches that exclude moisture during storage. Inspect each foil pouch before opening. Do not use devices that have holes in the foil or where the pouch has not been completely sealed. Erroneous result may occur if test reagents or components are improperly stored. · Do not use the Extraction Buffer if it is discoloured or turbid. Discolouration or turbidity may be a sign of microbial contamination. · All patient specimens should be handled and discarded as if they are biologically hazardous. All specimens must be mixed thoroughly before testing to ensure a representative sample prior to testing. · Failure to bring specimens and reagents to room temperature before testing may decrease assay sensitivity. Inaccurate or inappropriate specimen collection, storage, and transport may yield false negative test results. · Avoid skin contact with Extraction Buffer. · If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions and sent to state or local health departments for testing. · Viral isolation in cell culture and initial characterization of viral agents recovered in cultures of SARS-CoV-2 specimens are NOT recommended, except in a BSL3 laboratory using BSL3 work practices. STORAGE AND STABILITY · Store the Rapid Response® COVID-19 Antigen Saliva Test Kit at 2~30 when not in use. · DO NOT FREEZE. · Kit contents are stable until the expiration dates marked on their outer packaging and containers. TEST PROCEDURE Bring devices to room temperature (18~30) before use. 1. Open the pouch and remove the Saliva Collection Pen and Extraction Buffer Cap from the packaging. Label the Saliva Collection Pen with patient identification. For best results, the assay should be performed within two hours. 2. Clear throat, then cough deeply four times with mouth closed before collecting the samples. 3. Remove the plastic guard from the tip of the Saliva Collection Pen. 4. Place the Saliva Collection Pen in the mouth above the tongue. Hold in place for 2 minutes. 5. Remove the Saliva Collection Pen from the patient's mouth. Holding the Saliva Collection Pen vertically, place it into the Extraction Buffer Cap. Press down to break the seal of the Extraction Buffer Cap, which will release the buffer solution. 6. Start the timer immediately after breaking the seal. Read the results at 15 minutes. RESULT INTERPRETATION POSITIVE: Two coloured bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). NEGATIVE: Only one coloured band appears, in the control region (C): No apparent coloured band appears in the test region (T). INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. NOTE: 1. The colour intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of colour in the test region should be considered positive. Note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen. 2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure. QUALITY CONTROL Internal Procedural Controls The Rapid Response® COVID-19 Antigen Saliva Test Kit has built-in (procedural) controls. Each test device has an internal standard zone to ensure proper sample flow. The user should confirm that the coloured band located at the "C" region is present before reading the result. LIMITATIONS OF THE TEST 1. The Rapid Response® COVID-19 Antigen Saliva Test Kit is for professional in vitro diagnostic use and should only be used for the qualitative detection of SARS-CoV-2 antigen. The intensity of colour in a positive band should not be evaluated as "quantitative or semi-quantitative". 2. Both viable and nonviable SARS-CoV-2 viruses are detectable with the Rapid Response® COVID-19 Antigen Saliva Test Kit. 3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test but should only be made by the physician after all clinical and laboratory findings have been evaluated. 4. Failure to follow the TEST PROCEDURE and RESULT INTERPRETATION may adversely affect test performance and/or invalidate the test result. 5. Results obtained with this assay, particularly in the case of weak test lines that are difficult to interpret, should be used in conjunction with other clinical information available to the physician. 6. Negative results do not preclude SARS-CoV-2 infection and should be confirmed via molecular assay. PERFORMANCE CHARACTERISTICS Analytical Sensitivity (Limit of Detection): The limit of detection was determined with a quantified SARS-CoV-2 virus and has been evaluated at 1.25x101.4 TCID50/mL. The limit of detection was also determined with recombinant SARS-CoV-2 nucleoprotein and has been evaluated at 37 pg/mL. Clinical Evaluation: Clinical evaluations were performed in Switzerland using retrospective saliva samples. The clinical performance of the Rapid Response® COVID-19 Antigen Saliva Test Kit was compared with RT-PCR. The results are summarized below: Table: COVID-19 Antigen Saliva Test Kit vs. RT-PCR RT-PCR Positive Negative Total COVID-19 Antigen Positive 10 0 10 Saliva Test Kit Negative 0 12 12 Total 10 12 22 Relative Sensitivity: 100.0 % (69.2% ~ 100.0%)* Relative Specificity: 100.0 % (73.5% ~ 100.0%)* Overall Agreement: 100.0 % (84.6% ~ 100.0%)* *95% Confidence Interval Cross Reactivity: Cross reactivity with the following organisms has been studied. Samples positive for the following organisms were found negative when tested with the Rapid Response® COVID-19 Antigen Saliva Test Kit. Adenovirus 1 MERS-coronavirus Bordetella parapertussis Adenovirus 2 SARS-coronavirus Bordetella pertussis Adenovirus 3 Human metapneumovirus Candida albicans Adenovirus 4 Influenza A (H1N1)pdm09 Chlamydia pneumoniae Adenovirus 5 Influenza A (H3N2) Group C Streptococcus Adenovirus 7 Influenza B Victoria lineage Haemophilus influenzae Adenovirus 55 Influenza B Yamagata lineage Legionella pneumophila Epstein-Barr virus Norovirus Mycoplasma pneumoniae Enterovirus EV70 Parainfluenza virus 1 Mycobacterium tuberculosis Enterovirus EV71 Parainfluenza virus 2 Staphylococcus aureus Enterovirus A16 Parainfluenza virus 3 Staphylococcus epidermidis Enterovirus A24 Parainfluenza virus 4 Streptococcus agalactiae Enterovirus B1 Respiratory syncytial virus A Streptococcus pneumoniae Echovirus 6 Respiratory syncytial virus B Streptococcus pyogenes HCoV-229E Rhinovirus A30 HCoV-OC43 Rhinovirus B52 HCoV-NL63 Interfering Substances The following substances, naturally present in respiratory specimens or that may be artificially introduced into the respiratory tract, were evaluated at the concentrations listed below. None of them were found to affect test performance of the Rapid Response® COVID-19 Antigen Saliva Test Kit. Substance Concentration Substance Concentration 3 OTC nasal sprays 10% Guaiacol glyceryl ether 20 mg/ml 3 OTC mouthwashes 10% Mucin 1% 3 OTC throat drops 10% Whole Blood 4% 4-acetamidophenol 10 mg/ml Mupirocin 250 µg/ml Acetylsalicylic acid 10 mg/ml Oxymetazoline 25 µg/ml Albuterol 10 mg/ml Phenylephrine 10 mg/ml Chlorpheniramine 5 mg/ml Phenylpropanolamine 1 mg/ml Dexamethasone 50 µg/ml Zanamivir 10 mg/ml Dextromethorphan 10 µg/ml Adamantanamine 500 ng/ml Diphenhydramine 5 mg/ml Oseltamivir phosphate 10 mg/ml Doxylamine 1 mg/ml Tobramycin 10 mg/ml Flunisolide 25 µg/ml Triamcinolone 14 mg/ml LITERATURE REFERENCES 1. Forni, D., Cagliani, R., Clerici, M. & Sironi, M. Molecular evolution of human coronavirus genomes. Trends Microbiol. 25, 3548 (2017). 2. Ithete, N. L. et al. Close relative of human Middle East respiratory syndrome coronavirus in bat, South Africa. Emerg. Infect. Dis. 19, 16971699 (2013). GLOSSARY OF SYMBOLS Consult instructions for use Contains sufficient for <n> tests Catalogue number Temperature limitation Use by date Do Not Reuse In vitro diagnostic medical device Lot Number Manufacturer Authorized Representative BTNX, Inc. 570 Hood Rd, Unit 23 Markham, ON, L3R 4G7, Canada Technical Support: 1-888-339-9964 MDSS GmbH Schiffgraben 41 30175 Hannover, Germany BioservUK The Innovation Centre, 217 Portobello, Broomhall, A Calibre Scientific Company Sheffield S1 4DP, United Kingdom +44 114 224 2235 V1.5 Number INS001_06_COV-2PEN(05-2021) Effective date: 2021-05-20