FDA EUA Authorization
Fact Sheets for Healthcare Professionals
Fact Sheets for Recipients
The COVID-19 Corona Virus IgM/IgG Rapid Test is an in vitro diagnostic test solely for the qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood, serum, plasma and fingertip blood.
The test kit is based on immunoassay technology. The test devices contain:
- Conjugate pad: recombinant SARS-CoV-2 antigen labelled with colloidal gold and quality control antibody gold marker.
- NC membrane: coated with two detection lines (IgG line and IgM line) and one quality control line (C line). The IgM line coated with mouse anti human IgM monoclonal antibody detects the COVID-19 Corona Virus IgM antibody. The IgG line coated with mouse anti-human IgG monoclonal antibody detects the COVID-19 Corona Virus IgG antibody. The C line coated with quality control antibody. When sample is added to the sample well of the test device, it will move forward along the test device. If the sample contains IgM antibodies, antibodies will bind to the virus antigen labelled with colloidal gold, then forms a sandwich complex with the coated anti-human IgM monoclonal antibody at IgM line, IgM line will appear purplish red, prompting the COVID-19 Corona Virus IgM antibody is positive. If the sample contains IgG antibodies, antibodies will bind to the virus antigen labelled with colloidal gold, then forms a sandwich complex with the coated anti human IgG monoclonal antibody at IgG line, IgG line will appear purplish red, prompting the COVID-19 IgG antibody is positive. If either line IgG or IgM does not show colour, the negative result will be displayed. The test device also contains a quality control line C, whether there is a test line or not, quality control line C should display purplish red. Test result will be invalid if quality control line C does not show colour, this sample needs to be retested.
The Rapid Detection Kit is for professional use only and can be used in Centers for Disease Control and Prevention, Primary Health Care Institutions, Government Department / Public Institution State-Owned Enterprise / Large Company, Industrial Production Enterprise, Schools and/or Prison / Detention Center/ Drug Rehabilitation Center.
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 the FDA. The test has been validated but FDA's independent review of the test is pending.
- 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.