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Another antigen kit, LumiraDx SARS-CoV-2 Ag Test, has received an emergency use authorization (EUA) from the US Food and Drug administration (FDA) for COVID-19 testing. The test "quickly detects fragments of proteins found on or within the virus by testing samples collected from the patient’s nasal cavity using swabs. " In its authorization letter, the FDA specifies that "Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status and that "Negative results do not rule out SARS-CoV-2 infection..." and "...should be considered in the context of a patient’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19."
This is the third rapid antigen kit that the FDA has granted EUA for COVID-19 testing. The kit is manufactured by a British company LumiraDx.
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