COVID19 IgG & IgM 快篩檢測試劑 (IVD)
- Is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.
- Includes instructions that the test report (instructions for use) include information along the following lines:
- 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.
- Not for the screening of donated blood