小柯机器人

美国加州大学旧金山分校A. John Iafrate等研究人员合作对SARS-CoV-2血清学检测评估了一系列测试性能。这一研究成果于2020年8月27日在线发表在《自然—生物技术》上。

研究人员进行了十项即时护理式侧向流动测定（LFA）和两种基于实验室酶联免疫吸附测定的面对面评估，以检测5种抗SARS-CoV-2 IgM和IgG抗体从症状发作开始的5天时间间隔，并研究冠状病毒前2019年样本中每种测定的特异性。血清反应阳性个体的百分比随时间增加，在最近测试的时间间隔（症状发作后超过20天）达到峰值。测试特异性范围为84.3％至100.0％，主要受IgM结果变异性的影响。

通过将弱条带视为阴性可以提高LFA特异性，但这在SARS-CoV-2实时PCR阳性病例的群体中降低了抗体的检测（敏感性）。这些结果强调了血清阳性阈值确定和读取者培训对于可靠的LFA部署的重要性。尽管没有出色的血清学检测方法，但四项检测在后来的检测点均达到了80％以上的阳性率和95％以上的特异性。

据了解，正确使用和解释血清学检测能够评估SARS-CoV-2的暴露、感染和潜在的免疫力，但需要准确的测定数据。

附：英文原文

Title: Evaluation of SARS-CoV-2 serology assays reveals a range of test performance

Author: Jeffrey D. Whitman, Joseph Hiatt, Cody T. Mowery, Brian R. Shy, Ruby Yu, Tori N. Yamamoto, Ujjwal Rathore, Gregory M. Goldgof, Caroline Whitty, Jonathan M. Woo, Antonia E. Gallman, Tyler E. Miller, Andrew G. Levine, David N. Nguyen, Sagar P. Bapat, Joanna Balcerek, Sophia A. Bylsma, Ana M. Lyons, Stacy Li, Allison Wai-yi Wong, Eva Mae Gillis-Buck, Zachary B. Steinhart, Youjin Lee, Ryan Apathy, Mitchell J. Lipke, Jennifer Anne Smith, Tina Zheng, Ian C. Boothby, Erin Isaza, Jackie Chan, Dante D. Acenas, Jinwoo Lee, Trisha A. Macrae, Than S. Kyaw, David Wu, Dianna L. Ng, Wei Gu, Vanessa A. York, Haig Alexander Eskandarian, Perri C. Callaway, Lakshmi Warrier, Mary E. Moreno, Justine Levan, Leonel Torres, Lila A. Farrington, Rita P. Loudermilk, Kanishka Koshal, Kelsey C. Zorn, Wilfredo F. Garcia-Beltran, Diane Yang, Michael G. Astudillo, Bradley E. Bernstein, Jeffrey A. Gelfand, Edward T. Ryan, Richelle C. Charles, A. John Iafrate

Issue&Volume: 2020-08-27

Abstract: Appropriate use and interpretation of serological tests for assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure, infection and potential immunity require accurate data on assay performance. We conducted a head-to-head evaluation of ten point-of-care-style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays to detect anti-SARS-CoV-2 IgM and IgG antibodies in 5-d time intervals from symptom onset and studied the specificity of each assay in pre-coronavirus disease 2019 specimens. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 d after symptom onset). Test specificity ranged from 84.3% to 100.0% and was predominantly affected by variability in IgM results. LFA specificity could be increased by considering weak bands as negative, but this decreased detection of antibodies (sensitivity) in a subset of SARS-CoV-2 real-time PCR-positive cases. Our results underline the importance of seropositivity threshold determination and reader training for reliable LFA deployment. Although there was no standout serological assay, four tests achieved more than 80% positivity at later time points tested and more than 95% specificity. 

DOI: 10.1038/s41587-020-0659-0

Source: https://www.nature.com/articles/s41587-020-0659-0

Nature Biotechnology：《自然—生物技术》，创刊于1996年。隶属于施普林格·自然出版集团，最新IF：68.164
官方网址：https://www.nature.com/nbt/
投稿链接：https://mts-nbt.nature.com/cgi-bin/main.plex