04/09/2020
COVID-19 Testing
There are several different types of tests available for screening COVID-19. Four of them will be discussed here.
The nasopharyngeal swab detects SARS-CoV-2 (aka COVID-19) RNA by reverse-transcription polymerase chain reaction (RT-PCR). This test detects presence of current infection. The sample needs to be sent to a lab to be processed. The testing does not take long, but the labs have been overwhelmed with volume. The average turnaround time has been 5-7 days in the DC area.
Abbott received emergency use authorization (EUA) from the FDA for the Abbott RealTime SARS-CoV-2 assay. EUA means that the testing did not undergo the full degree of standard testing before FDA approval. The sensitivity and specificity of the tests are not yet known. We do not know how many false negatives or false positives the test yields. The test uses a nasal or oral viral swab. The test works by identifying the RNA of the virus then amplifying the RNA until there is enough for detection. This is a qualitative test run through Abbott’s m2000 RealTime system that identifies the presence of current infection. Contrary to the name, the sample must be sent to a certified lab for testing. The results are not immediate.
A week after getting EUA approval for the above test, Abbott developed the ID NOW COVID-19 test which is a point-of-care test that yields results in 15 minutes. The ID NOW system has FDA approval for Influenza A&B, Strep A, and respiratory syncytial virus (RSV) testing. It now has EUA by the FDA for COVID-19 testing. The test uses a nasal or oral viral swab and works by amplifying the RNA for detection and determines the presence of current infection.
Henry Schein has developed the point-of-care Standard Q COVID IgM/IgG Rapid test. It is a pinprick blood test that looks for antibodies and delivers results in 15 minutes. IgM antibodies fight active infections. As the infections subsides, our bodies make IgG memory antibodies. Detection of IgG indicates history of exposure. The test is a qualitative test that gives a yes or no answer to whether you were at some point exposed to COVID-19. It cannot determine when the exposure occurred or the level of antibody protection. Similar to the Abbott tests, it only has emergency use authorization from the FDA which leaves room to question the accuracy of the test. Nevertheless, the key to controlling spread of infection is knowledge of infection.
There are other companies developing testing, but the ones discussed here have already become available.