Authors: Diane Bronikowski, Nova Szoka, MD
Cellex Inc received FDA approval for qSARS-CoV-2 IgG/IgM Rapid Test on April 1, 2020.
Designed in response to the COVID-19 pandemic, the qSARS-CoV-2 IgG/IgM Rapid Test is the first FDA approved assay of its kind. The test qualitatively detects IgG and IgM immunoglobulins against SARS-CoV-2 present in venipuncture whole blood, serum, or plasma (EDTA or citrate) specimens. IgM is the first immunoglobulin made by the human body in response to infection and indicates recent exposure to the virus. IgG immunoglobulins are synthesized by the body for long-term protection and are present in the serum acutely after infection and persist for an indeterminant amount of time post exposure.
Results of the test should be read within fifteen to twenty minutes after adding the patient’s sample to the device cassette. Up to three separate, colored bands could appear as test results, an M Test Line (M), a Control Line (C), and a G Test Line (G). A positive test for the presence of IgM antibodies against SARS-CoV-2 is indicated by the C line and M line appearing. A positive test for the presence of IgG antibodies against SARS-CoV-2 is indicated by the C line and G line appearing. If the test is positive for both IgG and IgM antibodies, all three lines (M, C, and G) will appear. A negative test result occurs when only the C line appears. The Control Line should be present on every test and indicates adequate flow of reagents in the device cassette. If no colored band appears at the C line, the result is deemed invalid and should be repeated.
This test received FDA Emergency Use Authorization, pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act. Emergency use allows the test to be used prior to full-approval due to the life-threatening potential of SARS-CoV-2 and the lack of alternative testing methods available.