Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization

Area of Science:

• Clinical Microbiology
• Immunology
• Infectious Diseases

Background:

• Growing interest in serologic assays for detecting prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
• U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for numerous SARS-CoV-2 serologic assays.
• Need for standardized verification strategies and reporting considerations for laboratories implementing these assays.

Purpose of the Study:

• To provide expert recommendations for the verification of SARS-CoV-2 serologic assays with FDA EUA.
• To offer insights into assay limitations, reporting considerations, and implementation strategies for clinical laboratories.
• To guide laboratorians in the rapidly evolving landscape of SARS-CoV-2 serologic testing.

Main Methods:

• Expert consensus recommendations from clinical microbiologist members of the American Society for Microbiology (ASM).
• Review of verification strategies for single-antibody and multi-antibody isotype detection assays.
• Consideration of biosafety, quality control, and proficiency testing for assay implementation.

Main Results:

• Detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided.
• Discussion of differentiated and non-differentiated antibody class results.
• Identification of key considerations for assay limitations and laboratory reporting.

Conclusions:

• This document provides updated guidance for laboratorians on the application and verification of SARS-CoV-2 serologic assays.
• Adherence to recommended strategies ensures reliable detection of prior SARS-CoV-2 infection.
• Expert recommendations facilitate informed implementation and reporting of serologic testing in clinical settings.