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FDA Authorizes First COVID-19 Serology Test for Point-of-Care Use

NEW YORK – The US Food and Drug Administration announced late Wednesday that it has authorized the first antibody assay intended for use at the point of care to detect previous SARS-CoV-2 infection. The Assure COVID-19 IgG/IgM Rapid Test Device, which is manufactured by Hangzhou, China-based Assure Tech, is for use on finger-stick blood samples.

The 15-minute lateral flow test was first authorized in July to detect antibodies against the virus in venous whole blood, serum, and plasma.

The agency said in a statement that this authorization means that fingerstick blood samples can now be tested in POC settings like doctor's offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.

After months of guiding that tests intended for the point of care must used in labs, the agency found the Assure test met the standards to be used with fingerstick whole blood specimens at the point of care in patient care settings operating under CLIA certification.

FDA Commissioner Stephen Hahn commented that 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.

"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," Hahn said. "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," he added.

The agency noted that nearly 50 serology tests have been granted an EUA since the start of the pandemic.

It also reminded the public that it is unknown if antibodies confer protection against re-infection, that serology tests should not be used to diagnose an active infection, and that in a population with low prevalence even high-performing antibody tests may yield false-positive results and two sequential tests may be needed.

According to the FDA's previous performance analysis of blood samples, the Assure test has a sensitivity and specificity for IgM antibodies against SARS-CoV-2 of 100 percent and 99 percent, respectively. For IgG, the sensitivity is 90 percent, and the specificity is 100 percent. The agency estimated that at a prevalence of 5 percent, the positive predictive value of the test would be approximately 81 percent, while the negative predictive value would be 100 percent.

The test's instructions for use now also describe a fingerstick blood sample analysis of 42 positive and 113 negative samples collected and tested at three different POC sites, with a combined PPA after 15 days from PCR positivity of 100 percent for IgG and 89 percent for IgM.