评估七种血清学 SARS-CoV-2 检测方法在临床实验室中的临床性能。

Evaluation of the Clinical Performance of 7 Serological Assays for SARS-CoV-2 for Use in Clinical Laboratories.

机构信息

Department of Pathology and Laboratory Medicine, Cleveland Clinic, OH, USA.

出版信息

J Appl Lab Med. 2021 Jul 7;6(4):998-1004. doi: 10.1093/jalm/jfab038.

DOI:10.1093/jalm/jfab038

PMID:33825844

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8083591/

Abstract

BACKGROUND

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological assays have emerged as a response to the global pandemic, warranting studies evaluating their clinical performance. This study investigated 7 commercially available SARS-CoV-2 serological assays in samples from noninfected individuals and hospitalized patients.

METHODS

SARS-CoV-2 qualitative serological assays by Abbott (IgG), Beckman (IgG), DiaSorin (IgG), EUROIMMUN (IgG and IgA), Roche and Bio-Rad (Total) were evaluated using specimens collected pre-December 2019 (n = 393), from nucleic acid amplification testing (NAAT) negative patients (n = 40), and from 53 patients with COVID-19 by NAAT collected 3-21 days post-onset of symptoms (POS) (N = 83). Negative agreement (NA), positive agreement (PA), and positive and negative predictive values (PPV and NPV) at prevalences of 5% and 10% were calculated.

RESULTS

The overall %NA; 95% CI in the negative samples were: Roche 99.8%; 99.3-100.2, Beckman 99.8%; 98.7-100.0, Abbott and Bio-Rad 99.3%; 98.0-99.9, DiaSorin 98.4; 97.2-99.6, EUROIMMUN IgG 97.5%; 95.5-98.7, and EUROIMMUN IgA 79.7%; 75.9-83.5), accounting for positive/equivocal results as false positives. The %PA; 95% CI in samples collected 14+ days POS (n = 24) were: Bio-Rad 83.3%; 68.4-98.2, Abbott and Roche 79.2%; 62.9-95.4, EUROIMMUN IgA 70.8%; 52.6-89.0, Beckman 58.3%; 38.6-78.1, DiaSorin 54.2; 34.2-74.1, and EUROIMMUN IgG 50.0%; 30.0-70.0, accounting for negative/equivocal results as false negatives. NPVs ranged from 97.4%-98.9% and 94.7%-97.7% for prevalences 5% and 10%, respectively. PPVs ranged from 15.5%-94.8% and 27.9%-97.4% for prevalences 5% and 10%, respectively.

CONCLUSION

The Roche and Beckman assays resulted in fewer false positives, followed by the Bio-Rad and Abbott assays. While the Bio-Rad assay demonstrated higher antibody detection in COVID-19-positive patients, PA claims cannot be established with a high level of confidence in our sample population.

摘要

背景

严重急性呼吸系统综合征冠状病毒 2 （SARS-CoV-2）血清学检测已成为应对全球大流行的一种手段，需要研究来评估其临床性能。本研究评估了 7 种市售 SARS-CoV-2 血清学检测方法在非感染个体和住院患者样本中的表现。

方法

使用 Abbott（IgG）、Beckman（IgG）、DiaSorin（IgG）、EUROIMMUN（IgG 和 IgA）、罗氏和伯乐（总）的 SARS-CoV-2 定性血清学检测方法，评估了 2019 年 12 月前采集的标本（n=393）、核酸扩增检测（NAAT）阴性患者（n=40），以及 53 名 COVID-19 患者的标本，这些患者在症状出现后 3-21 天（POS）采集了 NAAT（n=83）。计算了 5%和 10%流行率下的阴性一致率（NA）、阳性一致率（PA）以及阳性和阴性预测值（PPV 和 NPV）。

结果

阴性样本的总 %NA；95%可信区间为：罗氏 99.8%；99.3-100.2，Beckman 99.8%；98.7-100.0，雅培和伯乐 99.3%；98.0-99.9，DiaSorin 98.4%；97.2-99.6，EUROIMMUN IgG 97.5%；95.5-98.7，EUROIMMUN IgA 79.7%；75.9-83.5），将阳性/不确定结果视为假阳性。在采集 14+ POS 日（n=24）的样本中，%PA；95%可信区间为：伯乐 83.3%；68.4-98.2，雅培和罗氏 79.2%；62.9-95.4，EUROIMMUN IgA 70.8%；52.6-89.0，Beckman 58.3%；38.6-78.1，DiaSorin 54.2%；34.2-74.1，EUROIMMUN IgG 50.0%；30.0-70.0，将阴性/不确定结果视为假阴性。对于流行率为 5%和 10%，NPV 分别为 97.4%-98.9%和 94.7%-97.7%。对于流行率为 5%和 10%，PPV 分别为 15.5%-94.8%和 27.9%-97.4%。