SARS-CoV-2 IgG/IgM Rapid Test
REF 502090 Specification 20 Tests/Box Detection principle Immunochromatographic assay Specimens Whole Blood / Serum / Plasma Intended Use This is a rapid immuno-chromatographic assay for the simultaneous detection of IgM and IgG antibodies to SARS-CoV-2 virus in human whole blood, serum or plasma.
The test is limited in the US to distribution to laboratories certified by CLIA to perform high complexity testing.
This test has not been reviewed by the FDA.
Negative results do not preclude acute SARS-CoV-2 infection.
Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.