Abbott COVID-19 Ag Card Home Test Kit Instruction Manual
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BinaxNOW COVID-19 Ag Card Home Test - Instructions for Use (Home Test)
BinaxNOW COVID-19 Ag Card Home Test Kit
2021-11-22 — For detailed instructions, please visit: BinaxNOWhometest.abbott.com. BinaxNOW COVID-19 Ag CARD HOME ... the swab can feel slightly uncomfortable or tickly.
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BinaxNOWTM COVID-19 Ag CARD HOME TEST KIT PROCEDURE CARD DO NOT OPEN ITEMS UNTIL INSTRUCTED TO DO SO The BinaxNOWTM COVID-19 Ag Card Home Test is for FDA Emergency Use Authorization (EUA) Only For Prescription Use Only For In Vitro Diagnostic (IVD) Use � This product has not been FDA cleared or approved but has been authorized by FDA under an EUA. � This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. � This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs 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. � For more information on EUAs go here: https://www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization � For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19 � For detailed instructions, please visit: BinaxNOWhometest.abbott.com BinaxNOW COVID-19 Ag CARD HOME TEST KIT Frequently Asked Questions Will this test hurt? No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a healthcare provider. What are the known and potential risks and benefits of this test? Potential risks include: � Possible discomfort during sample collection. � Possible incorrect test results (see Results section). Potential benefits include: � The results, along with other information, can help your healthcare provider make informed recommendations about your care. � The results of this test may help limit the spread of COVID-19 to your family and others in your community. You have the option to refuse this test. However, your doctor has prescribed this test because they believe it could help with your care. Hazardous Ingredients for the Reagent Solution Chemical Name/CAS GHS Code for each Ingredient Concentration Sodium Azide/26628-22-8 Acute Tox. 2 (Oral), H300 Acute Tox. 1 (Dermal), H310 0.0125% plenty of water. If irritation persists, seek medical advice. http://www.poison.org/contact-us or 1-800-222-1222. What is the difference between an antigen and molecular test? There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation. How Accurate is this Test? Based on the interim results of a clinical study where the BinaxNOWTM COVID-19 Ag Card Home Test was compared to an FDA authorized high sensitivity SARS-CoV-2 test, BinaxNOW COVID-19 Ag Card Home Test correctly identified 91.7% of positive specimens and 100% of negative specimens. The solution in the tube contains a hazardous ingredient (see table above). If the solution contacts the skin or eye, flush with BinaxNOW COVID-19 Ag CARD HOME TEST KIT Frequently Asked Questions Due to the relatively small sample size for the home use clinical study, the BinaxNOW COVID-19 Ag Card Home Test is estimated to correctly identify between 73.0% and 98.9% of positive specimens as reflected in the 95% Confidence Interval. This is consistent with the performance established in a separate multi-site clinical study in the US, where the BinaxNOW COVID-19 Ag Card test was performed and results interpreted by test operators with no laboratory experience. In that study, BinaxNOW COVID-19 Ag Card test correctly identified 84.6% of positive specimens and 98.5% of negative specimens. Based on this information, negative results may require additional testing to confirm your result. Please talk to your healthcare provider to determine if you need additional testing. BinaxNOW COVID-19 Ag CARD HOME TEST KIT Indication The BinaxNOW COVID-19 Ag Card Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset or adult collected nasal swab samples from individuals aged four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The BinaxNOW COVID-19 Ag Card Home Test is to be performed only with the supervision of a telehealth proctor. The BinaxNOW COVID-19 Ag Card Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. BinaxNOW COVID-19 Ag Card Home Test is only for use under the Food and Drug Administration's Emergency Use Authorization. All prescribing healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. BinaxNOW COVID-19 Ag CARD HOME TEST KIT Wash Your Hands Wash or sanitize your hands. Make sure they are dry before starting. BinaxNOW COVID-19 Ag CARD HOME TEST KIT 1 Set Up It is recommended gloves (not provided) also be used during testing. ! DO NOT open items until instructed. Open your test kit. You should have: 1 Swab 1 Test Card 1 Bottle CONTROL SAMPLE or BinaxNOWTM COVID-19 Ag CARD BinaxNOW COVID-19 Ag CARD HOME TEST KIT 2 Open Pouch and Scan QR Code on Card If using a mobile device: If using a computer: CONTROL SAMPLE BinaxNOWTM COVID-19 Ag CARD BinaxNOW COVID-19 Ag CARD HOME TEST KIT 3 Open Card ! Card must stay FLAT on table for entire test. Top Hole Bottom Hole Results Window Test Strip BinaxNOW COVID-19 Ag CARD HOME TEST KIT DO NOT touch any parts on inside of card. 4 Apply Fluid to Top Hole A. Remove dropper B. Hold dropper bottle bottle cap. straight over TOP HOLE, not at an angle. C. Put 6 DROPS into TOP HOLE. Do not touch card with tip. 6 drops BinaxNOW COVID-19 Ag CARD HOME TEST KIT Note: False negative results may occur if less than 6 drops of fluid is used. 5 Open Swab ! Keep fingers away from swab end. A. Open swab package at stick end. B. Take swab out. BinaxNOW COVID-19 Ag CARD HOME TEST KIT 6 Swab Left Nostril A. Insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into left nostril. B. Firmly brush against insides of nostril in a circular motion 5 times or more for at least 15 seconds. Up to 3/4 of an inch. x5 BinaxNOW COVID-19 Ag CARD HOME TEST KIT 7 Swab Right Nostril A. Remove swab and insert it into right nostril. B. Firmly brush against insides of nostril in a circular motion 5 times or more for at least 15 seconds. x5 Note: False negative results may occur if the nasal swab is not properly collected. BinaxNOW COVID-19 Ag CARD HOME TEST KIT 8 Insert Swab into Bottom Hole ! Keep card FLAT on table. Insert swab tip into BOTTOM HOLE and firmly push up until tip fills TOP HOLE. BinaxNOW COVID-19 Ag CARD HOME TEST KIT 9 Turn Swab 3 Times ! Keep card FLAT on table. Turn swab to right 3 times in card and leave it in place. Note: False negative results can occur if the sample swab is not turned prior to closing the card. x3 BinaxNOW COVID-19 Ag CARD HOME TEST KIT 10 Peel Strip ! DO NOT remove swab. ! Keep card FLAT on table. Keep swab in place. Peel adhesive liner off. BinaxNOW COVID-19 Ag CARD HOME TEST KIT 11 Close Card and Seal ! DO NOT remove swab. ! Keep card FLAT on table. Close left side of card over swab to seal it. Keep card face up on table. BinaxNOW COVID-19 Ag CARD HOME TEST KIT 12 Wait 15 Minutes ! DO NOT disturb card during this time. 15:00 BinaxNOW COVID-19 Ag CARD HOME TEST KIT Note: False results can occur if the card is disturbed/moved or test results are read before 15 minutes. 13 Scan QR Code If using a mobile device: If using a computer: CONTROL SAMPLE BinaxNOWTM COVID-19 Ag CARD BinaxNOW COVID-19 Ag CARD HOME TEST KIT 14 Show Result to Your Proctor CONTROL SAMPLE BinaxNOWTM COVID-19 Ag CARD CONTROL SAMPLE BinaxNOW COVID-19 Ag CARD HOME TEST KIT 15 Steps to Check Your Results There are three types of results possible. You will be instructed how to read each type in a specific order. Follow this order with your proctor: 1. Check for a Positive Result 2. Check for a Negative Result 3. Check for an Invalid Result BinaxNOW COVID-19 Ag CARD HOME TEST KIT 16 Check for Positive COVID-19 Result Find result window and look carefully for two pink/purple lines in window. � Positive Result: Two pink/purple lines will appear. One on the top half and one on the bottom half. COVID-19 was detected. Positive Positive CONTROL SAMPLE OR Solid Line Faint Line Look very closely! The bottom line can be very faint. Any pink/purple line visible here indicates a positive result. Here are photos of actual positive tests. On the right, note how faint the bottom line can get. BinaxNOW COVID-19 Ag CARD HOME TEST KIT Positive COVID-19 Result A positive test result means it is very likely you have COVID-19 and it is important to be under the care of your healthcare provider. The telehealth proctor is not a healthcare provider. It is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive result). Your healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms. BinaxNOW COVID-19 Ag CARD HOME TEST KIT 17 Check for Negative COVID-19 Result Find result window and look for a single pink/purple line in window. � Negative Result: A single pink/purple line on the top half where it says "Control." COVID-19 was not detected. Negative CONTROL SAMPLE No Line BinaxNOW COVID-19 Ag CARD HOME TEST KIT Negative COVID-19 Result A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. Negative results may require additional molecular testing to confirm that you do not have COVID-19. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If your test result is negative, please consult your healthcare provider. The telehealth proctor is not a healthcare provider. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. If you or the telehealth proctor disagree on the presence of a faint line and/or the presence of a line is uncertain, additional confirmatory testing should be conducted. It is important that you work with your healthcare provider to help you understand the next steps you should take. BinaxNOW COVID-19 Ag CARD HOME TEST KIT 18 Check for Invalid Result If you see any of these, the test is invalid. No lines seen CONTROL Blue control line only Pink/purple sample line only Blue control line AND pink/purple sample line SAMPLE BinaxNOW COVID-19 Ag CARD HOME TEST KIT 19 Dispose in Trash CONTROL SAMPLE BinaxNOWTM COVID-19 Ag CARD BinaxNOW COVID-19 Ag CARD HOME TEST KIT Reporting Patient Results Using NAVICA Upon completion of the test and result interpretation, the telehealth proctor will send your test results via the NAVICA app. You will be notified by email and on your mobile device that your results are ready. You will go to the results screen in NAVICA to obtain your test results. If your BinaxNOW COVID-19 Ag Card Home Test result is Negative, you will receive the following: If your BinaxNOW COVID-19 Ag Card Home Test result is Positive, you will receive the following: BinaxNOW COVID-19 Ag CARD HOME TEST KIT Reporting Patient Results Using NAVICA Upon completion of the test and result interpretation, the telehealth proctor will send your test results via the NAVICA app. You will be notified by email and on your mobile device that your results are ready. You will go to the results screen in NAVICA to obtain your test results. If the BinaxNOW COVID-19 Ag Card Home Test result is Invalid, you will receive the following: � 2021 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. IN195101 Rev 4 2021/03 BinaxNOW COVID-19 Ag CARD HOME TEST KIT Abbott BinaxNOW COVID-19 Ag Card Home Test Procedure Card Size: 16.35 in. x 12.21 in. Colors RGB For Reference Only PMS 2995 C Primary Blue PMS 303 C Dark Blue PMS 224 C Magenta-Pink PN: IN195101 Rev: 4 Date of Last Revision: 4.5 2021/03/28 Note: This version contains 2 CMYK elements = Navica Icon and RED bar Abbott BinaxNOW COVID-19 Ag Card Home Test Box, 1 Test Dieline: 2T5 Dimensions: 8-1/4 in. x 5 in. x 3/4 in. CMYK PMS 2925 C Primary Blue PMS 224 C Magenta Pink PMS 303 C Dark Blue Crease Line Do Not Print Cut Line Do Not Print PN: PK195100 Rev: 6 Date of Revision: 6.1 2021/02/12 81/4 5 3/4 BinaxNOWTM COVID-19 Ag Card HOME TEST BinaxNOWTM COVID-19 Ag Card HOME TEST This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, 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. BinaxNOWTM COVID-19 Ag Card HOME TEST EN A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. Contents: 1 BinaxNOWTM COVID-19 Test Card 1 Nasal Swab 1 Reagent Bottle Store between 35.6-86� F (2-30� C) until use Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, Maine 04074 USA www.globalpointofcare.abbott 195-100 � 2021 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. PK195100 Rev. 6 2021/02 No Ink/Varnish 3/4 2�C 121/16 1 195-100 Store between 35.6-86� F (2-30� C) until use 30�C 5 For use under an Emergency Use Authorization only. BinaxNOWTM COVID-19 Ag Card HOME TEST DO NOT OPEN UNTIL INSTRUCTED TO DO SO 195-100 DOWNLOAD THE NAVICATM APP and create an account prior to your appointment 113/4 113/4 5 3/4 5 3/4 81/4 INSIDE BOX LID ARTWORK 121/16