FDA Explains Differences Between Diagnostic and Antibody Tests

The U.S. Food and Drug Administration (FDA) published a new video explaining the different categories of tests in the fight against COVID-19 disease: diagnostic tests and antibody tests. 

As the video issued on June 4th explains, diagnostic tests can tell if the tested person currently is infected. Antibody or serology tests detect if the person’s blood contains antibodies to coronavirus. 

The body produces antibodies when one becomes infected by the virus, and they help the immune system fight off the infection. 

If an antibody test finds antibodies in the blood, it likely means the person has been previously infected with the virus. 

Antibody tests do not detect whether a person is currently infected and should not be used to diagnose a current COVID-19 infection. 

The results from antibody tests can help us better understand questions about exposure to the SARS-CoV-2 coronavirus, which causes COVID-19.

To date, the FDA has issued 120 Emergency Use Authorizations (EUA), which includes 104 molecular tests, 15 antibody tests, and 1 antigen test.

A EUA allows the agency to make available unauthorized treatments or diagnostics, based on a review of limited data, during a public health emergency.

‘Across local populations, testing produces more accurate results if the disease being tested for is common in the population,’ says the FDA.

If you think you have a coronavirus infection and need a test, contact your healthcare provider immediately. 

Or, contact your local health department regarding questions about testing, says the FDA.

During late May 2020, Quest Diagnostics announced that it has received EUA from the FDA for the Quest Diagnostics Self-collection Kit for COVID-19. 

This self-collection kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting, when determined to be appropriate by a healthcare provider.

Coronavirus Today publishes lab testing news.