Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings.
Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings.
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DOI：
10.1016/j.ijid.2021.07.010
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发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
Nagler M
中科院分区：
文献类型：
--
作者：
Jegerlehner S;Suter-Riniker F;Jent P;Bittel P;Nagler M
实验室检测是管理COVID-19大流行的主要手段，人们对快速抗原检测寄予厚望。然而，快速抗原检测在实际临床环境中的准确性尚不清楚，因为基本上缺乏设计充分的诊断准确性研究。本研究的目的是评估在初级/二级保健检测机构中快速抗原检测诊断SARS-CoV-2感染的准确性。招募了在瑞士大学医院附属的COVID-19检测机构就诊的连续个体（n = 1465%）。取鼻咽拭子，Roche/SD Biosensor快速抗原检测与2次real-time PCR检测（参比标准）并行进行。在招募的1465例患者中，141例RT-PCR阳性，相应的患病率为9.6%。罗氏/SD生物传感器快速抗原试验94例（6.4%）阳性，1368例（93.4%）阴性，3例样品材料不足。快速抗原检测的总敏感性为65.3%(95%可信区间[CI] 56.8 ~ 73.1)，特异性为99.9% （95% CI 99.5 ~ 100.0）。在无症状个体中，敏感性为44.0% （95% CI 24.4-65.1）。与制造商的数据相比，初级/二级医疗检测机构中SARS-CoV-2罗氏/SD生物传感器快速抗原检测诊断SARS-CoV-2感染的准确性要低得多。在这种环境下的广泛应用可能导致相当多的人被错误地归类为SARS-CoV-2阴性。
Laboratory tests are a mainstay in managing the COVID-19 pandemic, and high hopes are placed on rapid antigen tests. However, the accuracy of rapid antigen tests in real-life clinical settings is unclear because adequately designed diagnostic accuracy studies are essentially lacking. The aim of this study was to assess the accuracy of a rapid antigen test in diagnosing SARS-CoV-2 infection in a primary/secondary care testing facility. Consecutive individuals presenting at a COVID-19 testing facility affiliated to a Swiss University Hospital were recruited (n = 1465%). Nasopharyngeal swabs were obtained, and the Roche/SD Biosensor rapid antigen test was conducted in parallel with two real-time PCR tests (reference standard). Among the 1465 patients recruited, RT-PCR was positive in 141 individuals, corresponding to a prevalence of 9.6%. The Roche/SD Biosensor rapid antigen test was positive in 94 patients (6.4%), and negative in 1368 individuals (93.4%; insufficient sample material in 3 patients). The overall sensitivity of the rapid antigen test was 65.3% (95% confidence interval [CI] 56.8–73.1), the specificity was 99.9% (95% CI 99.5–100.0). In asymptomatic individuals, the sensitivity was 44.0% (95% CI 24.4–65.1). The accuracy of the SARS-CoV-2 Roche/SD Biosensor rapid antigen test in diagnosing SARS-CoV-2 infections in a primary/secondary care testing facility was considerably lower compared with the manufacturer's data. Widespread application in such a setting might lead to a considerable number of individuals falsely classified as SARS-CoV-2 negative.
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影响因子：
12.4
作者：
Brigger D;Horn MP;Pennington LF;Powell AE;Siegrist D;Weber B;Engler O;Piezzi V;Damonti L;Iseli P;Hauser C;Froehlich TK;Villiger PM;Bachmann MF;Leib SL;Bittel P;Fiedler M;Largiadèr CR;Marschall J;Stalder H;Kim PS;Jardetzky TS;Eggel A;Nagler M
通讯作者：
Nagler M
Stard 2015：用于报告诊断准确性研究的基本项目的更新列表。
DOI：
10.1136/bmj.h5527
发表时间：
2015-10-28
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Bossuyt PM;Reitsma JB;Bruns DE;Gatsonis CA;Glasziou PP;Irwig L;Lijmer JG;Moher D;Rennie D;de Vet HC;Kressel HY;Rifai N;Golub RM;Altman DG;Hooft L;Korevaar DA;Cohen JF;STARD Group
通讯作者：
STARD Group
影响因子：
--
作者：
Mallett, Susan;Halligan, Steve;Altman, Douglas G.
通讯作者：
Altman, Douglas G.
影响因子：
39.2
作者：
Whiting, Penny F.;Rutjes, Anne W. S.;Bossuyt, Patrick M. M.
通讯作者：
Bossuyt, Patrick M. M.