According to Stanford Medicine, the Stanford Health Care Clinical Virology Laboratory has developed a test for COVID-19. The test works by utilizing reverse-transcriptase polymerase chain reaction technique, which uses DNA primers to bind to the viral genome. This allows for the detection of envelope proteins and RDRP, both of which are characteristic of viruses. In other words, this test’s function is to identify viral RNA genomes. According to the University, the FDA relaxed its restrictions and established an Emergency Use Authorization mechanism for COVID-19 diagnostic tests on February 29, allowing this test to be implemented.
The Emergency Use Authorization implemented by the FDA also made the qSARS-CoV-2 IgG/IgM Rapid Test available for use, according to an FDA fact sheet. The Rapid Test measures IgG and IgM titers produced in response to COVID-19. Detection of IgM titers indicates that the patient has an active or recent COVID-19 infection. If IgG titers are detected, it indicates a past infection. If the two antibodies are detected together, it is likely that the patient had the infection and is still contagious.
Both sources make it clear that these tests are not 100% accurate, and false-positives may be a result. It is also unsure of how sensitive these tests are. With that being said, I think it was extremely important for the FDA to institute the Emergency Use Authorization. I understand that the organization likes to have more proven data to approve things, however, in a time when such large quantities of people are getting sick and dying, it is crucial that we do whatever we can to attempt to stop the spread of this disease. In my opinion, it would better for the tests to be false-positives and some patients are quarantined even if they are safe, than if there were no tests and people who had COVID-19 were unknowingly spreading the infection.
Christian Brewster Microbiology 