WASHINGTON – To ensure the proper use of antibody testing for the novel coronavirus, AACC today issued a public statement detailing the role these tests should play in the management of COVID-19 patients and in the development of public health policy. In particular, the organization emphasizes that healthcare professionals and policymakers should work closely with laboratory experts on antibody testing to ensure that these tests are validated, used appropriately, and interpreted correctly.
The statement can be read here: https://www.myadlm.org/science-and-practice/statements-on-covid-19-testing/aacc-recommendations-for-sars-cov-2-serology-testing
COVID-19 antibody testing in the U.S. has been fraught with problems, one of which is that the market has been flooded with antibody tests of dubious quality. This is partly due to the fact that, in response to concerns that FDA regulation was hindering COVID-19 testing, the agency temporarily allowed diagnostic manufacturers to sell antibody tests without undergoing FDA review. The agency is now requiring manufacturers of these tests to apply for emergency use authorization, but there is still variability in test performance and characteristics. This has left healthcare providers and researchers struggling to clarify which antibody tests are reliable and accurate. In addition, as knowledge of COVID-19 infection evolves, conflicting views have arisen within the medical and public health communities about how COVID-19 antibody testing can contribute to patient care and to the development of strategies to contain the pandemic.
In order to bring clarity to these issues, AACC’s members—who are laboratory experts on the frontlines of COVID-19 testing—have released a statement that describes the ins and outs of serology tests and makes recommendations on their use and interpretation. First and foremost, the organization emphasizes that healthcare institutions should only use antibody tests that are FDA authorized or that were developed by a laboratory certified by CMS to create in-house tests. Before implementation of any antibody test, laboratory medicine professionals must also evaluate the test’s accuracy and reliability even if it already underwent FDA review. The group further states that antibody testing is not suitable for diagnosis but can be complementary to molecular tests in clinical and public health settings.
The statement provides easily understandable definitions for terms that define a test’s characteristics, such as sensitivity, specificity, and cross-reactivity. The statement also describes the effect of prevalence, or level to which the disease is present in a community, on the interpretation of results for public health policy decisions.
“Our understanding of COVID-19 and the tests used to detect and manage infection will increase as our global scientific and clinical communities work together to understand this novel virus,” said AACC President Dr. Carmen Wiley. “As we work toward gaining a better understanding of this illness, we urge healthcare professionals to work closely with laboratory professionals, who play an indispensable role in developing and performing diagnostic and serologic tests and providing guidance in their proper use and interpretation.”
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.