BinexNOW

BinaxNOW Self Test

Update 02/03/2022: After a few weeks of shortages, the situation changed. On Jan.18, 2022, news outlet CNET WELLNESS published that free at-home COVID-19 tests were available from the USPS.

Four free at-home tests per household from USPS

USPS site was running an offer:

Place Your order for Free At-Home COVID-19 Tests

Residential households in the U.S. can order one set of 4 free at-home tests from USPS.com. Here’s what you need to know about your order:

– Limit of one order per residential address

– One order includes 4 individual rapid antigen COVID-19 tests

– Orders will ship free

Fill in this form with your contact and shipping information to order your tests.

I placed an order and received my tests in 5 days.

Availability of the free at-home tests was widely publicized and on Jan. 28, 2022, CNET WELLNESS published an update that

Americans have already ordered nearly 60 million free COVID at-home tests.

Tests can be ordered online at the USPS site special.USPS.com/testkits  and covidtests.gov site or by calling a hotline at 1-800-232-0233.


Eight at-home tests per month paid by insurance

On Jan 20, 2022, news outlet KQED published an article At-Home COVID Test Reimbursement: From Blue Shield to Kaiser, How to Get Your Health Insurance to Pay You Back. This program covers eight at-home tests per month for an individual insured by a health plan and is different from the described above USPS order of the free tests from the federal government. The KQED article includes a guide on how major insurers like Kaiser Permanente, Blue Shield of California, UnitedHealthcare (UHC), Cigna, Anthem Blue Cross, Aetna handle reimbursement of tests. Some reimburse after purchase, others cover cost upfront, so you need to know what is available for you before you buy a test.

You can learn more about insurance reimbursement at the Centers for Medicare & Medicaid Services CMS.gov site.

Jan. 2, 2022. My community chat members have been reporting difficulties getting a COVID-19 diagnostic test appointment at the clinics in our area, with massive queues, while many of the test stations are now closed. Those looking to purchase self-test kits online have complained about the long delivery times.

I decided to buy Abbott Labs BinaxNOW Antigen Self Test kit online, to have one on hand. The kit has two tests for serial testing, for a reasonable price of about $14.00.

The search for the BinaxNOW at Walmart came with “Out of Stock”.

Searching at Abbott Global Point of Care for the San Diego area showed that all major local pharmacies, Walgreens, Rite Aid, CVS, Amazon, Sam’s Club are out of stock.

BinaxNow FDA Approval Status

Could BinaxNOW FDA approval status be causing this situation? At this time the BinaxNOW Self Test is listed among FDA In Vitro Diagnostics EUAs – Antigen Diagnostics Tests for SARS-CoV-2 . Authorization documents are HCPIndividualsIFUIFU (Home Test). FDA issued the EUA for the Abbott Diagnostics test on 03/31/2021, with the last update on 11/08/2021.

FDA letter of authorization for the current EUA BinaxNOW COVID-19 Antigen Self Test includes the requirement

to evaluate the impact of SARS-CoV-2 viral mutations on your product’s performance. Such evaluations must occur on an ongoing basis and must include any additional data analysis that is requested by FDA in response to any performance concerns you or FDA identify during routine evaluation. (page 8, paragraph R)

This test has been identified among the ones for which SARS-CoV-2 mutations can have an impact on performance. According to FDA,

data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity.

Since there are no FDA restrictions on manufacturing, what is causing this shortage? And what is the situation with other COVID-19 self tests? The following day a local news outlet publishes an article, “All COVID-19 test kits at libraries no longer available. They claims that

due to high demand, the supply of 70,000 COVID-19 home test kits at local libraries have all been distributed to the public. 

These tests are no longer available from the local libraries

I purchased 2 kits from iHealth Labs Inc. on Amazon for $17.98 each (kit contains 2 tests). Delivery time was set at 12 days, but it was actually delivered in 3 days.

If rapid test kits are not readily available to the public, stop the spread becomes an empty slogan.

Last Updated on February 7, 2022 by covid