SARS-CoV-2 Tests

Authored by
Staff
Last reviewed
December 6, 2022

SARS-CoV-2 Coronavirus Tests

The U.S. Food and Drug Administration (FDA) recently confirmed it had authorized over 400 tests and sample collection devices under emergency use authorizations (EUAs). The FDA updated the information about at-home over-the-counter COVID-19 diagnostic tests, Antibody Testing Information for Patients and Consumers, and the question and answer resources: COVID-19 Test Development and Test Uses.

'The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.' And the U.S. CDC published updated guidelines on August 11, 2022.

Previously, the WHO issued interim guidance on using SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing.

Isolation and Exposure Calculator

The U.S. CDC published the Isolation and Exposure Calculator on August 11, 2022, to help people determine if they need to isolate or take other steps to prevent the spreading of the coronavirus.

At-Home OTC COVID-19 Diagnostic Test

According to the CDC's report on March 25, 2022, there was a rapid increase in at-home test use between the SARS-CoV-2 Delta- and Omicron-predominant periods. And on May 16, 2022, the government confirmed every home in the U.S. is eligible to order the 3rd round of free at-home tests.

On April 29, 2022, the JAMA Network published: Comparison of Home Antigen Testing With RT-PCR and Viral Culture During SARS-CoV-2 Infection and a Research Letter in January 2022: False-Positive Results in Rapid Antigen Tests for SARS-CoV-2. The overall rate of false-positive results among the total rapid antigen test screens for SARS-CoV-2 was very low.

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 essential to tell if someone has been previously infected. In addition, 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.

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 and 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

On May 16, 2022, the U.S. FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19. 

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 that cause them, says the CDC.