Patricia Slev, PhD, ARUP Immunology Division section chief and University of Utah associate professor of pathology, is an author of newly published COVID-19 antibody testing guidelines. Slev was a member of an expert panel convened by the American Association for Clinical Chemistry (AACC) to provide a comprehensive reference for clinicians and laboratory professionals on the appropriate use and interpretation of SARS-CoV-2 antibody tests.
According to the AACC, several professional organizations have issued interim guidelines on COVID-19 antibody testing, but no guidance to date has comprehensively addressed issues such as assay validation, selection, utilization, performance, and limitations. “These guidelines provide comprehensive recommendations that range from clinical interpretation to practical application,” Slev said. “They are extremely valuable for clinicians, researchers, and laboratorians.”
A team of AACC clinical laboratory experts that included Slev collaborated to investigate published literature and generate a comprehensive, convenient, and up-to-date resource. “We aimed to write something that would summarize our current knowledge and provide practical guidance for laboratories that want to validate and perform SARS-CoV-2 serology testing,” Slev explained. “We saw a need and combined our experience to develop something that answers the needs of the community.“
The new AACC guidelines provide in-depth understanding of the SARS-CoV-2 humoral response, including neutralizing antibodies and antibody kinetics. They also describe the clinical utility and limitations of SARS-CoV-2 serologic testing and offer information about the use of serology in vaccinated individuals. For a more detailed discussion about serology for vaccinated individuals, please read, “What Is the Utility of COVID-19 Laboratory Testing in Vaccinated Individuals?”
Another highlight of the guidance is that it provides up-to-date information on the characteristics of antibody tests that have earned Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). The new guidelines also offer a systematic approach that clinical labs can use to validate the performance of these tests and laboratory-developed tests. “In addition to larger clinical laboratories and healthcare facilities, many smaller laboratories or facilities with limited expertise in test validation will benefit from the comprehensive information in the new guidelines,” Slev said.
Kirsten Meek, PhD, Medical Writer and Editor