COVID-19 IgM/IgG Antibody Rapid Test
This kit is not intended for at home use.
25 tests each. Suitable for the qualitative detection of Coronavirus (SARS-CoV-2 / COVID-19) N-Protein IgM / IgG antibodies in human serum, plasma, whole blood, or finger prick samples.
The ProMed® COVID-19 IgM/IgG Antibody Rapid Test is an in vitro diagnostic test for the qualitative detection of IgM & IgG antibodies to the SARS‐CoV‐2 in human whole blood, serum, or plasma specimens collected in CLIA certified laboratories and/or by healthcare workers at the point‐of‐care.
- This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.
- 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.
This product is for in vitro diagnostic use, following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020. This test has not been reviewed by the FDA and 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.
In order to order the COVID-19 IgM/IgG Rapid Test, we need to confirm that you are a health professional or working in a laboratory. Please complete the below form and if we need further verification, we will contact you. Thank you for your cooperation.
Product: Coronavirus (COVID-19) IgM/IgG Rapid Test Kit