NEW YORK – The US Food and Drug Administration on Friday granted Emergency Use Authorization to a rapid serology test from Xiamen Biotime Biotechnology. The test detects and differentiates IgG and IgM antibodies against SARS-CoV-2 virus in patient blood samples.
Specifically, the Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test is authorized for the detection of antibodies from patient serum, as well as plasma and venous whole blood in EDTA. The lateral flow test requires one drop of blood and provides a colorimetric readout after 10 minutes. It is authorized for use in moderate- and high-complexity CLIA labs.
According to the instructions for use of the test on the FDA's website, the test was evaluated at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI) on May 29. It was validated against a panel of previously frozen samples consisting of 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples.
This NCI evaluation showed the Biotime test to have a sensitivity of 100 percent and a specificity of approximately 99 percent for IgM. The IgG component had a sensitivity of approximately 97 percent and a specificity of approximately 98 percent. The combined sensitivity and specificity was determined to be 100 percent and approximately 96 percent, respectively.