A rapid test for the qualitative detection of IgG and IgM antibodies to 2019-nCov, SARS-CoV-2 in human Fingerstick Whole Blood specimens. For professional in vitro diagnostic use only. The SARS-CoV-2, 2019-nCOV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCov in human Fingerstick Whole Blood specimen. Early January 2020, a novel coronavirus (2019-nCOV), (SARS-CoV-2) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019. Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Six coronavirus species are known to cause human disease. Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals. The two other strains — severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness.Coronaviruses are zoonotic, meaning they are transmitted between animals and people. The 2019-nCOV IgG/IgM Rapid Test Cassette (Fingerstick Whole Blood) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to 2019-nCOV in Fingerstick Whole Blood specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with 2019-nCOV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to 2019-nCOV. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to 2019-nCOV, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result. Therefore, if the specimen contains 2019-nCov IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains 2019-nCOV IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain 2019-nCOV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.