The US Centers for Disease Control and Prevention (CDC) Data Tracker reported over 490 million RT-PCR diagnostic tests had been performed to confirm SARS-CoV-2 virus infections. As of June 11, 2021, the percentage of COVID-19 NAATs that are positive has decreased from the previous week. The 7-day average of percent positivity from tests is now 1.8%.
As of June 8, 2021, the U.S. Food and Drug Administration (FDA) announced it had authorized 384 coronavirus diagnostic tests, including 275 molecular tests, 81 antibody tests, and 28 antigen tests during the COVID-19 pandemic. Furthermore, 52 molecular authorizations can be used with home-collected samples. In addition, there is one molecular prescription at-home test, two antigen prescription at-home tests, four OTC at-home antigen tests, and two OTC molecular tests.
The FDA recently published A Closer Look at COVID-19 Diagnostic Testing to offer those who might purchase COVID-19 tests more technical information and resources. And molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test. This FDA page, updated on June 3, 2021, provides information regarding the impact of viral mutations on COVID-19 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 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.
Diagnostic Test News Is Available At This Link
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.