As a result, the COVID-19 IgG and IgM Rapid Test is being distributed in compliance with the above FDA granted EUA. This qualitative serology test is designed to detect the antibodies (specific proteins) that develop in the body following exposure to COVID-19. IgM antibodies are typically released in the early stages of an infection. IgG antibodies are typically the body’s longer-term response to an infection. Researchers are trying to determine how quickly the body produces these COVID-19 antibodies and current estimates are that the IgM antibodies might be released within approximately the first week after infection. Symptoms of COVID-19 are generally appearing 1-14 days following viral exposure.
The U.S. has struggled to test for this virus at scale. This is related to the limited availability of molecular polymerase chain reaction (PCR) tests that require samples to be sent to a laboratory and, therefore, may take days to get results back. The speed of this new 10 minute rapid test allows decision makers to be more responsive in proactively decreasing the spread of the Coronavirus. Test results may be helpful in determining who should be self-quarantined.
This test is to be used only for pre-screening purposes.
In an effort to assist our communities in pre-screening those with potential Coronavirus symptoms, we are offering this COVID-19 IgG and IgM 10-minute Rapid Test. The test procedure involves a simple fingerstick which according to preliminary research yields a high sensitivity, high specificity result. Once ordered, we will deliver an easy to administer kit which will include a package insert/procedure guide.
If the test is positive, the tested person might have COVID-19. They should contact their medical/healthcare provider for further guidance. Self-quarantine is advisable.
If the test is negative, there is a chance this could be a false negative if the tested person has the infection but the antibody has not yet been produced by the body. If the tested person has symptoms of COVID-19, or a potential exposure to COVID-19, the tested person should contact their medical/healthcare provider regarding recommendations for further testing and self-quarantine.
We want to make our partners aware that this test is not meant to replace PCR testing. Because the PCR test detects the RNA (genetic material) of the virus, it remains the most accurate testing available.