Rapid COVID Test Kit
The Rapid IgM-IgG Combined Antibody Test for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.
On March 16, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updates include guidance for commercial manufacturers such as DentMed Supply for serology test that identify antibodies (e.g., IgM, IgG) to sARS-CoV-2 from clinical specimens. The policy allows testing in laboratories or by healthcare workers at the point-of-care. The policy does not apply to at-home testing.
Laboratories and healthcare providers must include this information in their patient test report as specified in FDA guidance:
- This test has not been reviewed by 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.
This product has CE-IVD registration.