Self tests

Self-testing has the potential to be an innovative component to community-wide HIV-prevention strategies. This testing method could serve populations who do not have access to standard voluntary counselling and testing services or because of privacy concerns, stigma, transport costs, or other barriers do not use facility-based, standard HIV testing. This paper reviews recent research on the acceptability, feasibility, and cost of rapid testing and home-specimen collection for HIV, and suggests that self-testing may be another important strategy for diagnosing HIV infection. Several research questions are posed that should be answered before self-testing is realised.

Did you just get home with your BinaxNOW Self Test? Want to be sure you're conducting the test correctly? Here's a quick video that includes a step-by-step guide, start to finish, on how to conduct a BinaxNOW Self Test.

Now that you have the BinaxNOW Self Test under control, here are answers to some of the questions you might have:

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1. How do I test myself or someone else?

Using the BinaxNOW Self Test is simple, even if you have never tested yourself before. You simply will perform a lower nostril nasal swab (not the deeper nasopharyngeal swab) and everything you need (swab, test card and reagent solution) is included in the box. Each test kit comes with an illustrated quick reference guide to walk you through the process step by step.

2. Who should use this test?

The test is indicated for all people aged 15 years or older and for children as young as 2 years old when samples are collected by an adult. The test can be used for people with and without symptoms.

3. Should people who were vaccinated use this test?

Testing will remain an essential part of our short- and long-term recovery strategy. The BinaxNOW Self Test will be a key tool alongside vaccination as we get back to life. We don't yet know how long vaccines confer immunity and how variants will evolve.

4. How will people report their test results?

People are encouraged to follow the latest CDC guidelines, which is to communicate your results to your healthcare provider, who is responsible for reporting your test results to the state health department.

5. How many tests come in a package?

There are two tests (as well as two swabs and reagents) in each box.

6. How long should people wait between taking BinaxNOW Self Tests?

The tests should be administered twice over three days with at least 36 hours between tests.

7. Can the BinaxNOW Self Test be thrown into the garbage after use?

You can recycle the box, but should dispose of the test card, nasal swab and test solution in common household waste, in line with the test's instructions for use.

8. How do I know if I have a positive or negative test?

To check for a positive result, look at the result window for two pink or purple lines. Even a faint line next to the word "sample" on the test card is a positive result. A negative result will have only one pink or purple line on the top half of the results window where it says "control."

9. What if my test result is invalid?

If your results window has any of the following, the test result may be invalid:

  • No lines appear by control or sample
  • The control line is blue and not pink/purple
  • There is a pink/purple line by sample, but no line by control
  • The control line is blue, but the sample is pink/purple

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If you see an invalid result, contact our technical support on this number: +1 833-637-1594.

Anything you're still unsure of?

For more about the BinaxNOW Self Test and to contact our technical support team.

IMPORTANT SAFETY INFORMATION

The BinaxNOW™  Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from individuals with or without symptoms or other epidemiological reasons to suspect  infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older.

The BinaxNOW  Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from, not for any other viruses or pathogens, and are 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 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.