Many are asking since listening to my interview on the Sarah Westall Show, “Where to get the COVID-19 IgM/IgG Rapid Test.” Find it at BioMedomics.
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 BioMedomics 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.