The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals. This test has been authorized by the FDA under a EUA for professional use CLIA and CLIA WAIVED for Point Of Care. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This product is intended for professional use and not for home use. FACT SHEET FOR HEALTHCARE PROVIDERS This test has been authorized by the FDA under a EUA for use by authorized CLIA laboratories. This device is CLIA waived for point of care use for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. There should be a blue line in the control region (next to ) before testing, discard the device if there is no blue line.
