Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
J Clin Microbiol. 2020 Dec 17;59(1). doi: 10.1128/JCM.02148-20.
Interest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitations and reporting considerations for laboratories. Assessments concerning single-antibody and multiantibody isotype detection assays, which may provide either differentiated or nondifferentiated (i.e., total antibody) antibody class results, are addressed. Additional considerations prior to assay implementation are also discussed, including biosafety, quality control, and proficiency testing strategies. As the landscape of SARS-CoV-2 serologic testing is rapidly changing, this document provides updated guidance for laboratorians on application of these assays.
人们对血清学检测在检测严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）既往感染中的作用的兴趣持续增长。美国食品和药物管理局（FDA）已授予许多 SARS-CoV-2 血清学检测紧急使用授权（EUA）。在本文件中，美国微生物学会（ASM）临床微生物学家成员提供了有关 FDA EUA 的 SARS-CoV-2 血清学检测详细验证策略的专家建议，以及对实验室检测局限性和报告注意事项的见解。还讨论了针对单抗体和多抗体同种型检测检测的评估，这些检测可能提供区分或不区分（即总抗体）抗体类别的结果。在实施检测之前，还讨论了其他考虑因素，包括生物安全、质量控制和能力验证策略。由于 SARS-CoV-2 血清学检测的情况正在迅速变化，本文件为实验室人员提供了有关这些检测应用的最新指南。
