The US Centers for Disease Control and Prevention (CDC) Data Tracker reported over 528 million RT-PCR diagnostic tests had been performed to confirm SARS-CoV-2 coronavirus infections. As of September 3, 2021, the percentage of COVID-19 nucleic acid amplification tests that are positive reached 9.6% for the prior 7 days.
As of August 31, 2021, the U.S. Food and Drug Administration (FDA) announced it had authorized 409 coronavirus diagnostic tests, including molecular tests, antibody tests, and antigen tests during the COVID-19 pandemic. Furthermore, molecular authorizations can be used with home-collected samples. In addition, there is one molecular prescription at-home test, antigen prescription at-home tests, OTC at-home antigen tests, and OTC molecular tests.
SARS-CoV-2 Diagnostic Test Panels
Diagnostic testing analyzes the qualitative detection of nucleic acid from the COVID-19 disease in upper and lower respiratory specimens such as nasal swabs, throat swabs, and, if possible, sputum collected from individuals who meet COVID-19 clinical and/or epidemiological criteria. Nucleic acid amplification tests are molecular tests that detect the virus's genetic material collected from the patient.
SARS-CoV-2 Serological Test
Antibody testing is an important step to tell if someone has been previously infected. It will provide more understanding of the coronavirus, including how long antibodies stay in the body. However, if they provide immunity, there is no identified advantage of assays on whether they test for IgG, IgM, IgG, or total antibody, says the CDC. The serology or antibody test measures the number of antibodies present in the blood when the body responds to a specific infection, like SARS-CoV-2.
Currently, Authorized SARS-CoV-2 antibody tests are not validated to evaluate specific immunity or protection from SARS-CoV-2 infection. For more information about antibody testing, see Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers; and Serology/Antibody Test FAQs on Testing for SARS-CoV-2.
SARS-CoV-2 Lateral Flow Tests
Lateral flow tests (LFTs) can tell you if you’re infected with COVID-19 within minutes, rather than waiting 24-48 hours for the results of a PCR test. A recent Cochrane Review (March 2021) combined the results of multiple studies assessing the accuracy of LFTs, found that the average sensitivity of such tests was 72% among people with COVID-19 symptoms, and 58% for people without symptoms.
SARS-CoV-2 Combination Tests
The U.S. FDA assists healthcare providers in preparing for the 2020-2021 flu season during the COVID-19 pandemic by issuing emergency use authorizations for diagnostic tests to detect and differentiate the viruses that cause COVID-19 disease and influenza. While the seasonal Flu and COVID-19 are both contagious respiratory illnesses, but unlike viruses cause them, says the CDC.
Note: If you think you have COVID-19 and need a test, contact your healthcare provider immediately. Or, contact your local health department regarding questions about testing. The FDA's COVID-19 Industry Hotline (1-888-INFO-FDA, press *) addresses questions on topics such as diagnostic testing. If you received a COVID-19 vaccination, be aware that if you have a positive test result on a SARS-CoV-2 antibody test, it is possible you were previously infected with SARS-CoV-2. A COVID-19 vaccination may also cause a positive antibody test result for some but not all antibody tests.
SARS-CoV-2 Test News
After December 31, 2021, the U.S. CDC will withdraw the request to the U.S. FDA for Emergency Use Authorization of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC provides this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.
NOTE: The information is sourced from organizations such as the CDC, NIH, WHO, and the Precision Vax news network and reviewed by Dr. Robert Carlson.