The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma as an aid in the diagnosis of primary and second SARS-COV-2 infections. The test is for professional use only. The COVID-19 IgG/IgM Rapid Test Device detects anti-SARS-CoV-2 IgG/IgM antibody through visual interpretation of color development. Anti-human IgG and anti-human IgM are used to detect specific antibodies in the human whole blood, serum, or plasma specimen. When specimen is added to the sample well, specific IgM and/or IgG antibodies, if present, will bind to the SARS-CoV-2 antigens conjugated to colored particles on the conjugate pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgM and/or anti-human IgG antibodies immobilized on the test region(s). Excess colored particle are captured at the internal control region. The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that membrane wicking is working. This product is FDA Approved. FDA Approval Letter: FDA Letter
COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) clinical trials were performed at two sites in China from February 2020 to March 2020. These clinical trials were aimed to evaluate the performance of COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) by comparing with PCR.