Emergency authorization granted for first COVID-19 antibody test
The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization to Cellex Inc. for its qSARS-CoV-2 IgG/IgM RapidTest, designed to detect IgM and IgG antibodies in serum, plasma, or venipuncture whole blood, according to a letter sent Wednesday to the manufacturer.
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) are authorized to perform the tests. This is the first approval of a serology test for the novel coronavirus (COVID-19), which will allow laboratories to determine exposure in the antibodies, according to FDA representatives.
The label issued by the agency notes to purpose of the test at this time is to aid in the diagnosis of patients with COVID-19, but in conjunction with clinical presentation and the results of other laboratory tests.
According to the label, “negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.”
The label also notes, “false positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.”