Fingerstick COVID-19 Test Now Authorized

Assure COVID-19 IgG/IgM Rapid Test Device is a lateral flow assay
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(Precision Vaccinations)

The U.S. Food and Drug Administration (FDA) issued an authorization for the first serology point-of-care (POC) test to detect the SARS-CoV-2 virus.

This FDA emergency use authorization (EUA) announced on September 23, 2020, authorizes the test for POC use using fingerstick blood samples and is available by prescription only in the USA.

This means that fingerstick blood samples can now be tested in POC settings, such as pharmacies and doctor’s offices rather than having to be sent to a central lab for testing.

The Assure COVID-19 IgG/IgM Rapid Test Device is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma, and fingerstick whole blood. This serology POC test, unlike POC COVID-19 diagnostic tests, uses a blood sample from the fingertip to run the test.

The Assure Test was first authorized by the FDA for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection.

“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D., in a press statement. 

“Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time-consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”

The FDA said it ‘wants to remind patients that it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity, so they should not interpret results from a serology test as telling them they are immune, or have any level of immunity, from the virus.’ 

‘Due to these unknowns, the FDA cautions patients against using the results from these tests, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work.’

The FDA also wants to remind the public that serology tests should not be used to diagnose an active infection, as they only detect antibodies the immune system develops in response to the virus – not the virus itself. 

It is also important to remember that in a population with low prevalence, even high-performing antibody tests may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small. Thus, it is necessary to consider that the results from two serology tests may be needed to generate reliable results.

Nearly 50 serology tests have been granted an FDA EUA since the start of the COVID-19 pandemic during 2019. 

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.

PrecisionVaccinations publishes research-based coronavirus pandemic news.