Control for SARS-CoV-2 Serologic Assay
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Mixture of recombinant humanized IgG and IgM monoclonal antibodies directed against the NP protein of SARS-CoV-2 virus. This serves as an excellent and harmless positive control for Anti-SARS-CoV-2 immunoassays.
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This is an Antibody Serologic Assay (SCSA) for SARS-CoV-2.
This test has not been reviewed by the FDA.
The SARS-CoV-2 Antibody rapid test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM/IgG anti-SARS CoV-2 antibody which may be found in samples such as serum, plasma, whole blood or cell culture media. This product is suitable for screening for the presence of SARS-CoV-2 reactive antibody in a Research Use Only Fashion.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
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.