Counterfeit COVID-19 Home Diagnostic Tests Threaten Public Health: FDA

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The United States Food and Drug Administration (FDA) wants the public to be aware of the counterfeit over-the-counter (OTC) COVID-19 diagnostic tests circulating in the United States, according to a recent press publication.

“Counterfeit Covid-19 Test they are tests that are not licensed, approved, or approved by the FDA for distribution or use in the United States, but are made to look like licensed tests so that users think they are the real FDA cleared test, “the said. administration .

“The performance of these bogus tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests.”

Home diagnostic kits are primarily antigen tests.

One of the covid-19 tests distributed as part of the Biden administration’s effort to strengthen home testing.
(Digital Fox)

“First, antigen is something (virus, bacteria, pollen, etc.) that causes the human body to produce an immune response to that substance. In the case of a virus, the body can respond by making antibodies against the substance. virus“Dr. Michael Blaivas told Fox News.

He is the chief medical officer of Anavasi Diagnostics, a National Institutes of Health-backed Rapid Acceleration of Diagnostics company and molecular diagnostics platform designed for the future of home testing.

“An antigen test looks for the same antigen that the human immune system looks for with antibodies, but instead uses laboratory-made antibodies. When those antibodies (in the antigen test) bind to the target (virus) they can be made to give a signal, which the test will recognize and know it was positive for the virus. ”


But home antigen tests are not always correct, sometimes causing a “false negative” or “false positive” result.

A false negative antigen test result is when a test comes back negative even if the person did COVID-19, which can lead to delayed diagnosis and treatment. Not only can this cause serious harm to patients, including serious illness and death, but it can also lead to the spread of the SARS-CoV-2 virus without realizing it, according to the FDA.

The CDC said home testing must be supervised by a telemedicine provider associated with the test manufacturer.

The CDC said home testing must be supervised by a telemedicine provider associated with the test manufacturer.

Conversely, a false positive antigen test result is when the test says someone has COVID-19 even if they don’t. This can also have negative consequences because the patient may be delayed in both the diagnosis and treatment of an alternative life-threatening disease that needs to be treated.

The FDA recommends checking their list of authorized diagnostic tests listed on their website here to make sure the purchased test kit is not counterfeit, but patients can also contact the test manufacturer directly to confirm that the test is FDA cleared.

Some signs that the COVID-19 home OTC diagnostic test may be counterfeit include poor print quality on external labels and grammatical and spelling errors on product labels. The FDA recommends always looking for the lot number, expiration date, barcode or QR codes on the outer labels.

“When you open the testo kit box, look at the components inside and make sure they match the contents described. If the instructions on how to use the kit are missing, either the unfilled or missing components or the number of components is different from that listed on the packaging, you may be dealing with a counterfeit product, “added Blaivas.

The FDA is currently aware of two counterfeit home diagnostic tests: Flowflex COVID-19 Antigen Home Tests and iHealth COVID-19 Antigen Rapid Test Kits.

“The best place to buy home kits will be your local pharmacy. As pharmacies and other physical stores are more likely to have established sources for purchasing the products they sell to you, introducing counterfeit products will be more difficult. for criminals to reach, but not impossible, “Blaivas told Fox News.

Ellume recalls hundreds of thousands of home test kits for coronavirus due to false positives

Ellume recalls hundreds of thousands of home test kits for coronavirus due to false positives

If you shop online, look for negative reviews regarding whether the tests have false negative and positive results, rather than positive reviews, because it’s easy for scammers to buy positive reviews, he added.

Antigenic tests are generally faster, but “… in most cases they will be much less sensitive (not able to detect viral infection as well)” than polymerase chain reaction (PCR) tests that look for ” … evidence of actual viral genetic code, rather than relying on something that may or may not bind to some virus in the sample, ”Blaivas noted.

PCR tests remain the gold standard for diagnosing a patient with COVID-19, according to the Cleveland Clinic.

“The test involves several chemical reactions that basically focus on key portions of the virus’s genetic code. The chemical processes cut the strands of the viral genetic code (mRNA) and then make many copies of those fragments of the genetic code,” Blaivas explained.


But these tests are traditionally only performed in hospital laboratories and can take longer to get results than antigen tests, but “… by streamlining some of the processes, as we did for the Anavasi Diagnostics test, you can actually get a result in less than 30 minutes.”


Blaivas noted that his company’s diagnostic test is currently under review by the FDA for Emergency Use Authorization (EUA), but hopes it will be approved for EUA within the next few months for patients from use in their homes.

“The distribution of counterfeit COVID-19 products is a threat to public health. The FDA regularly monitors the commercialization of unauthorized, unapproved, or unapproved tests, including reports of problems with performance or test results. The FDA is working with manufacturers to address this security problem. ”