Cross-reactivity: This test device has no cross reactivity with endemic human coronavirus OC43 antibody, influenza A virus antibody, influenza B virus antibody, respiratory syncytial virus antibody, adenovirus antibody, EB virus antibody, measles virus antibody, cytomegalovirus antibody, rotavirus antibody, norovirus antibody, mumps virus antibody, varicella-zoster virus antibody, and mycoplasma pneumoniae antibody.
Clinical Performance of the test
220 Clinical samples based on the nucleic acid detection method (PCR) test results were obtained including 93 positive and 127 negative samples. The Sars-CoV-2 Antibody Test was compared with nucleic acid method (PCR) using the collected clinical samples. The results are summarized below:
Diagnostic Sensitivity: 98.9%
Diagnostic Specificity: 97.6%
Results in 15 minutes
INSTRUCTIONS FOR USE
This test has not been reviewed by the FDA.
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.
Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. This policy does not apply to at-home testing, including at-home specimen collection, due to additional considerations that require FDA review.
Link to FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)