BinaxNOW COVID-19 Antigen Self Test Kit

BinaxNOW Ag Covid Test Kit Features

• Results in 15 minutes
• Abbott Covid Test detects multiple strains, including the DELTA variant
• BinaxNOW Covid Test Kit detects active COVID-19 infection.
• Requires a minimally invasive nasal swab sample
• Easy to follow illustrated step-by-step covid antibody test instructions
• Know your result now, without the need to wait for results from your healthcare provider
• Self-test Kit for Covid-19 is compatible with the NAVICA app to capture your results for self-reporting
• Each kit box contains two test cards to enable you to test yourself twice within 3 days, with at least 36 hours between tests

What to buy with At-Home Rapid Covid Test Kit

• LYSOL Disinfectant Spray
• LYSOL Disinfecting Wipes
• Ansell Encore Latex Textured Surgical Gloves

How to use BinaxNOW COVID-19 Antigen Self-Test Kit?

Preparations for the At-Home COVID-19 Rapid Test

1. Wash or sanitize hands using a hand sanitizer. Make sure your hands are dry before covid testing.
2. Remove Covid Rapid Test Kit from pouch and lay flat on table. The card must stay flat on the table for the entire test. Make sure the blue control line is present in the result window. If a blue line is not present, do not use this card. Open card flat on the table. You may bend the spine in the opposite direction to help the card lay flat.
3. Note: Do not touch any parts on the inside. Handle cards only by edges. Card must stay Flat on the table for the entire test.
4. Remove dropper bottle cap. Hold dropper bottle straight over the top hole, not at an angle. Put 6 drops into the top hole. Do not touch card with tip.
5. Note: False negative result may occur if less than 6 drops of fluid are put in the hole.
6. Open swab package at stick end. Take swab out.
7. Note: Keep fingers away from the swab end.
8. Swab both nostrils carefully as shown. Insert the entire soft tip of the swab into a nostril (usually 1/2 to 3/4 of an inch). You do not need to go deeper. Using medium pressure, rub the swab against all of the inside walls of your nostril. Make at least 5 big circles. Do not just spin the swab. Each nostril must be swabbed for about 15 seconds. Using the same swab, repeat step 5 in your other nostril.
9. Note: False negative result may occur if the nasal swab is not properly collected.
10. Insert swab tip into bottom hole. Firmly push the swab tip from the bottom hole until it is visible in the top hole. Do not remove the swab from the card.
11. Note: Keep card flat on table.
12. Turn the swab to right 3 times to mix the swab with the drops. Do not skip this step. Leave the swab in the card for the remainder of the test.
13. Note: False-negative result can occur if swab is not turned.
14. Peel adhesive liner off. Be careful not to touch other parts of card. Close left side of card over swab. Press firmly on the two lines on right edge of card to seal. Keep card face up on table.
15. Wait 15 minutes. Read the result at 15minutes. Do not read the result before 15 minutes or after 30 minutes.

Reading COVID-19 Test Results on BinaxNOW COVID Test Card

Check for Positive COVID-19 Result: Find result window and look carefully for two pink/purple lines. Positive Result: If you see two pink/purple lines (one on the top half and one on the bottom half), this means Coronavirus was detected. Below are photos of actual positive tests. On the right, note how faint the bottom line can get.

 

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Check for Negative COVID-19 Result: Find result window and look for a single pink/purple line in window. Negative Result: If you see only one pink/purple line on the top half, where it says "Control" this means COVID-19 was not detected.

 

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Check for Invalid Result: If you see any of these, the test is invalid. An invalid result means this test was unable to determine whether you have COVID-19 or not. A new test is needed to get a valid result.

• Blue control line only
• No lines seen
• Pink/purple sample line only
• Blue control line and pink/purple sample line.

 

Proper Disposal of the BinaxNow Covid Test Kits

Properly dispose of all the used components of the test kit in trash and wash your hands afterwards.

Reporting Results of the At-Home COVID-19 Rapid Test

• Please share your test result with your health care provider.
• A second test should be obtained over three days with at least 36 hours between tests.

Precautionary Measures while Dealing with BinaxNOW COVID-19 Rapid Test Kit

• For in vitro diagnostic use.
• Wear safety mask or other face covering when collecting anterior nares swab specimen from a child or another individual.
• Use of gloves is recommended when conducting testing.
• Keep testing kit and kit components out of the reach of children and pets before and after use.
• This test has not been FDA cleared or approved but has been authorized by FDA under an EUA.
• BinaxNOW Ag Card Home Test has been authorized only for the detection of proteins 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.
• Proper sample collection and handling are essential for correct results.
• Do not use a kit that has been opened and/or tampered with.
• Leave test card sealed in its foil pouch until just before use.
• Do not use if pouch is damaged or open.
• Do not dip the swab into the liquid reagent or other liquid before inserting the swab into the nose.
• Do not touch swab tip when handling the swab sample.
• Do not use kit past its expiration date.
• Do not mix components from different kit lots.
• All kit components are single use items.
• Do not use with multiple specimens.
• Do not reuse the used test card.
• Dispose of kit components and patient samples in household trash.
• Invalid results can occur when an insufficient volume of extraction reagent is added to the test card. To ensure delivery of adequate volume, hold bottle vertically, 1/2 inch above the swab well, and add drops slowly.
• The Reagent Solution contains a harmful chemical (see user manual). If the solution contacts the skin or eye, flush with copious amounts of water. If irritation persists, seek medical advice immediately!

Abbott BinaxNOW Covid Test User Manual

How to Store the BinaxNOW Antigen Covid Test Kit?

• Store kit between 35.6-86°F (2-30°C).
• Ensure all test components are at room temperature before use.
• The Abbott Rapid Covid Test is stable until the expiration date marked on the outer packaging and containers.

BinaxNOW COVID 19 Test Kit FAQs

1. Will the Binax NOW Covid 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.

2. What is the Difference Between an Antigen and Molecular COVID Tests?

   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.

3. How Accurate is the Rapid Covid Test?

   Based on the interim results of a clinical study where the BinaxNow Covid Test Kits was compared to an FDA authorized high sensitivity SARS-CoV-2 test, BinaxNOW Covid 19 Antigen Self-Test correctly identified 91.7% of positive specimens and 100% of negative specimens.

4. What are the Risks and Benefits of BinaxNOW COVID-19 Rapid Test Kit?

   • 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 Covid 19 Test may help limit the spread of COVID-19 to your family and others in your community.