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The Rapid Response™ 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 (including venous whole blood and capillary whole blood), serum, or plasma. At the Point of Care setting, this test is only authorized for use with fingerstick whole blood specimens. The Rapid Response™ COVID-19 IgG/IgM Rapid Test Device should not be used for screening patients or to diagnose or exclude acute SARS-CoV-2 infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. A negative or non-reactive result for an individual subject indicates absence of detectable COVID-19 virus antibodies.
Result time: 60 minutes