The US Centers for Disease Control and Prevention (CDC) Data Tracker reported over 647 million RT-PCR diagnostic tests had been performed to confirm SARS-CoV-2 coronavirus infections. As of November 19, 2021, the percentage of COVID-19 nucleic acid amplification tests that are positive reached 6% for the previous seven days.
As of November 23, 2021, the U.S. Food and Drug Administration (FDA) confirmed it had authorized 423 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.
Visit the FDA website for a list of authorized COVID-19 diagnostic methods.
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 Antibody 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, unlike viruses cause them, says the CDC.
November 22, 2021 - The FDA authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests for people age 14 years or older with a self-collected nasal swab sample or people age 2 years or older when an adult collects the nasal swab sample.
November 10, 2021 - The U.S. Department of Health and Human Services will invest $650 million from the American Rescue Plan to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests and increase Americans’ access to them.
November 1, 2021 - The FDA reissued a EUA for the OraSure Technologies InteliSwab COVID-19 Rapid Test that produces results in 30 minutes.
October 21, 2021 - The JAMA Network published an article: The Flawed Science of Antibody Testing for SARS-CoV-2 Immunity. The problem isn’t simply that the tests weren’t designed to assess immunity, experts told JAMA. It’s also that the protective antibodies and their thresholds still haven’t been fully worked out.
October 4, 2021 - ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced today that its Flowflex™ COVID-19 Antigen Home Test had been authorized for emergency use by the U.S. Food and Drug Administration.
October 1, 2021 - Labcorp announced that it received Emergency Use Authorization from the U.S. FDA for a combined home collection kit that detects COVID-19 and influenza A/B simultaneously in individuals as young as two years of age. The kit will be available at no upfront cost to those who meet clinical guidelines, which may include experiencing symptoms, being exposed to someone with COVID-19, or if asked to be tested by a health care provider.
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.
The information is sourced from organizations such as the CDC, NIH, WHO, and the Precision Vax news network and reviewed by Dr. Robert Carlson.