For healthcare providers' point of care diagnoses of COVID-19 antibodies
WHAT IS THE SARS-CoV-2 IgM/IgG RAPID ANTIBODY TEST?
The SARS-CoV-2 IgM/IgG Antibody Rapid Test is an in-vitro diagnostic immunochromatographic assay used in the detection of SARS-CoV-2 antibodies (IgM and IgG) in whole blood or serum from individuals who are suspected of COVID-19 infection but display little to no symptoms. With only two drops of blood from the fingertip, the test can determine the presence of immunoglobulins IgM and IgG, which are found in the blood of people who have been exposed to the SARS-CoV-2 virus. With clear results in 15 minutes, healthcare professionals can make a quick, reliable diagnosis without the need for a laboratory. Precious time will be saved that will help contain the further spread of the virus.
HOW IT WORKS
When the body is exposed to a virus, the immune system begins to produce antibodies to fight the virus and future infections from it. Those antibodies remain behind after the virus is cleared from the body, which the tests detect. This confirms a previous infection. These tests could be especially useful for determining whether health care workers have some immunity and are at lower risk if they go back to work. Unlike other COVID-19 tests, the CoV-2 Rapid test can also determine current infection phase. A positive IgM value indicates an infection in the early phase of the disease (4 to 10 days), and a positive IgG value indicates a later phase (from 11 - 24 days).
- Sensitivity 97.5%
- Specificity 99.5%
ONE TEST KIT CONTAINS:
- 25 Test cassettes
- 25 Capillary samplers
- 1 Buffer reagent solution bottle
- 1 Package insert
MATERIALS REQUIRED BUT NOT PROVIDED:
- Alcohol pad
NOTE: For in vitro diagnostic use only
Notified FDA for Emergency Use Authorization (EUA) under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019.
- 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.