Stop using these: FDA warns some COVID-19 tests could be giving false results

Coronavirus

FILE — At home COVID-19 test. (Getty Images)

AUSTIN (KXAN) — The U.S. Food and Drug Administration is asking people to stop using LuSys Laboratories COVID-19 tests because they have not been approved by the FDA and “there is likely a high risk of false results.”

The FDA reports tests may also come under the name Luscient Diagnostics, Vivera Pharmaceuticals or EagleDx. The FDA believes that these tests were distributed for use in laboratories and for at-home testing.

KXAN has checked with several testing companies and public health agencies and did not find any that were using the tests. Austin Public Health confirmed their sites did not use the tests, so did large testing companies across Central Texas such as Curative.

Luscient Diagnostics’ website notes: “our COVID-19 Antigen Rapid Test has been submitted to the FDA EUA for review” but does not address the FDA’s concerns.

If you are a healthcare professional, the FDA recommends contacting and retesting patients. If you are someone who took one of the potentially faulty tests, you’re asked to retest using a different brand.

At-home versus PCR tests

Dr. Desmar Walkes, the Austin-Travis County health authority, says even though antigen tests may not detect omicron as well as PCR tests do, they are still recommending that people use them as a way to regularly screen for COVID-19.

If you’re experiencing symptoms though, Walkes recommends getting a confirmatory PCR test before returning to work or school.

“For sure, if someone is symptomatic and they receive a negative antigen test they should still self-isolate, not go out into public, not go to work, not go back into school until there is established that it is negative with a PCR test,” Walkes said.

The FDA does have a list of tests approved for use. KXAN has a list of places to get a COVID-19 test in Austin here.

If you suspect issues with a COVID-19 test, the FDA is asking you to report it to the MedWatch online voluntary reporting form.

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