April 14, 2020 -- The American Association for Clinical Chemistry (AACC) has acknowledged problems with some commercial serology tests for the novel coronavirus, while also advocating for a hands-off regulatory approach when it comes to assays developed by CLIA-certified labs.
In a statement on April 14, AACC President Carmen Wiley, PhD, noted that there have been "worrying reports" of a small number of unreputable diagnostic companies taking advantage of the relaxation of U.S. Food and Drug Administration (FDA) rules during the coronavirus pandemic. Initially, the FDA required all entities to secure an emergency use authorization (EUA) on tests for SARS-CoV-2/COVID-19. The restrictions were controversial. But in mid-March the agency relaxed regulations for vendors and also labs developing their own tests to permit marketing without an EUA.
"This decision has greatly increased the availability of COVID-19 tests, but an unfortunate new consequence is that reports are now surfacing of unreliable commercial COVID-19 serological tests," Wiley said.
Most commercial companies have been acting in good faith, but some have been falsely claiming that their tests are FDA-authorized, Wiley noted. The FDA recently vowed to take action against companies that are making false claims about serological tests for the novel coronavirus.
While investigating false claims and revisiting criteria for EUAs, the agency should keep a hands-off approach when it comes to laboratory-developed tests (LDTs), according to the AACC. LDTs are subject to stringent regulations under CLIA and the U.S. Centers for Medicare and Medicaid Services (CMS) and validated by lab experts, the AACC explained. They are "needed more than ever now that it is becoming clear that not all of the commercial tests are performing up to par," Wiley said.
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