FDA warns against using some antigen, antibody tests due to high risk of false results

Coronavirus

(NEXSTAR) – The U.S. Food and Drug Administration is calling on consumers to stop using one company’s antigen and antibody tests due to inadequate performance and the high risk of false results.

According to the FDA’s Tuesday warning, the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test have not been authorized or approved for distribution or use in the U.S. The antigen test uses a nasal swab or saliva while the antibody test uses serum, plasma, or blood samples.

The tests, believed to have been distributed for use in laboratories or for at-home testing, are currently being sold under the company name Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx.

The FDA reports both tests to have the possibility of giving false-negative and false-positive results but doesn’t indicate which is more prevalent.

If you have used either the antigen or antibody test from LuSys Laboratories, the FDA recommends speaking with your healthcare provider if you have concerns about your results. Any problems experienced with the tests can be reported on the FDA’s MedWatch Voluntary Reporting Form. If you have either of these tests, the FDA recommends not using it.

In November, over two million at-home COVID-19 tests were recalled by manufacturer Ellume due to the potential for false-positive results.

The FDA has a list of COVID-19 testing kits that have been approved for use in the U.S.

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