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[BMJ发表论文]:新冠肺炎血清学检查的诊断准确性:系统回顾和meta分析
2020年08月29日 时讯速递, 进展交流 暂无评论

Research

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Mayara Lisboa Bastos, Gamuchirai Tavaziva, Syed Kunal Abidi, et al

BMJ 2020; 370: m2516 doi: https://doi.org/10.1136/bmj.m2516 (Published 01 July 2020)

Abstract

Objective 目的

To determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).

确定新冠病毒感染(COVID-19)血清学检查的诊断准确性。

Design 设计

Systematic review and meta-analysis.

系统回顾和meta分析

Data sources 数据来源

Medline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.

采用与COVID-19及COVID-19血清学检查相关的主题词或小标题结合文本词语,检索2020年1月1日至4月30日间Medline, bioRxiv, 和 medRxiv发表的文献。

Eligibility criteria and data analysis 入选标准及数据分析

Eligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.

入选研究报告了COVID-19血清学检查的敏感性和(或)特异性(以病毒培养或RT-PCR为参照标准)。患者或标本量不足5例的研究被排除。采用QUADAS-2评估偏倚风险。采用随机效应二元meta分析模型评估综合敏感性和特异性。

Main outcome measures 主要结局指标

The primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.

主要结局指标为总体敏感性和特异性,根据血清学检测方法(ELISA, LFIA或CLIA)以及免疫球蛋白种类(IgG和(或)IgM)进行分层。次要结局指标为根据研究或人群特征分层的敏感性和特异性(包括距离发病时间)。

Results 结果

5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).

检索到5016篇参考文献,最终纳入40篇研究。进行了49项偏倚风险评估(对于研究人群和方法)。98% (48/49) 具有患者选择偏倚高风险,73% (36/49) 在血清学检查操作及解读方面具有高风险或风险不明。仅有 10% (4/40) 的研究纳入门诊患者。仅有2项研究对床旁检测方法进行了评估。对于各种检测方法而言,综合敏感性和特异性与检测的免疫球蛋白种类无关。对IgG 或 IgM进行ELISA检测的综合敏感性为 84.3% (95% CI 75.6% to 90.9%), LFIA检测的敏感性为66.0% (49.3% to 79.3%), CLIAs 为 97.8% (46.2% to 100%)。LFIA即床旁检测方法的综合敏感性最低。综合特异性为 96.6% 到 99.7%。在用于评估特异性的标本中,83% (10 465/12 547)来自暴发流行前人群或非COVID-19疑似患者。在LFIA检查中,市售检测试剂的敏感性 (65.0%, 49.0% to 78.2%) 低于非市售试剂 (88.2%, 83.6% to 91.3%)。所有分析都具有明显的异质性。发病至少3周后敏感性(从69.9% 到 98.9%)高于发病1周内(从13.4% 到 50.3%)。

Conclusion 结论

Higher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.

迫切需要高质量临床试验评价COVID-19血清学检测的诊断准确性。现有证据不支持继续采用现有床旁血清学检测方法。

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