Home 5 Articles 5 AACC Guidelines Caution Against Using Serology Tests to Determine COVID-19 Vaccine Efficacy

AACC Guidelines Caution Against Using Serology Tests to Determine COVID-19 Vaccine Efficacy

by | May 22, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet, Must read

Although SARS-CoV-2 serology tests have yet to live up to the hype, they are still expected to play a crucial role in coronavirus infection control efforts going forward. In addition to accuracy concerns, testing laboratories that develop and manufacture Emergency Use Authorization (EUA) and laboratory developed test (LDT) serology tests have been bedeviled by confusing and sometimes contradictory messaging and regulation. However, new guidelines from the American Association of Clinical Chemistry (AACC) may help clear up the confusion and get SARS-CoV-2 serology testing back on track. The Diagnostic Challenge When the pandemic first began, many hailed serology tests that detect antibodies the body creates to fight SARS-CoV-2 as holding the key to not only rapid widespread testing but also efforts of public health officials to track infection rates and prevalence in different communities. Among the early believers was the U.S. Food and Drug Administration (FDA) which initially allowed SARS-CoV-2 serology tests to reach the market without EUA. Literally hundreds of assays passed through the floodgates, many of which lacked anything close to the scientific reliability and accuracy required for EUA status. Dozens of these junk tests were recalled. Not until May 4, nearly three months into the public health emergency, […]

Sign up for our free weekly Lab & Pathology Insider email newsletter

Subscribe to Clinical Diagnostics Insider to view

Start a Free Trial for immediate access to this article