Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as of November 20, 2020.
Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as of November 20, 2020.
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现实世界中的现实SARS-COV-2快速抗原测试在可疑的Covid-19：截至2020年11月20日，可用数据的系统荟萃分析。
DOI：
10.1016/j.ijid.2021.05.029
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发表时间：
2021-07
期刊：
影响因子：
--
通讯作者：
Zemmrich C
中科院分区：
文献类型：
--
作者：
Hayer J;Kasapic D;Zemmrich C
快速抗原试验（rat）是一种用于辅助诊断SARS-CoV-2感染的侧流式色谱免疫测定法。我们进行了系统的荟萃分析来比较市售rat的实际性能。我们检索了多个数据库和网站，以比较SARS-CoV-2大鼠和RT-PCR的独立于制造商的前瞻性临床表现研究。仅纳入不需要单独阅读器检索结果的大鼠研究，并报告了病毒载量、患者症状状态、样本类型和使用PCR检测的数据。纳入19项研究，涉及11109份样本，其中2509份为rt - pcr阳性。RAT敏感性在28.9% （95% CI 16.4-44.3）和98.3% （95% CI 91.1-99.7）之间变化，可能取决于群体特征、病毒载量和症状状态。RAT特异性在92.4% （95% CI 87.4-95.9）和100% （95% CI 99.7-100）之间变化，有一个异常值。罗氏诊断/SD Biosensor和雅培的RATs的总灵敏度最高（分别为82.4% [95% CI 74.2-88.4]和76.9% [95% CI 72.1-81.2]）。高病毒载量样本（周期阈值≤25）的敏感性在不同的rat中表现出异质性。罗氏诊断/SD生物传感器和雅培提供的RATs提供了足够的独立于制造商的实际性能数据，以支持其用于检测当前的SARS-CoV-2感染，特别是在高病毒载量人群中。
Rapid antigen tests, or RATs, are a type of lateral flow chromatographic immunoassay utilized to aid the diagnosis of SARS-CoV-2 infection. We performed a systematic meta-analysis to compare the real-world performance of commercially available RATs. We searched several databases and websites for manufacturer-independent prospective clinical performance studies comparing SARS-CoV-2 RATs and RT-PCR. Only studies on RATs that did not need a separate reader for result retrieval and that reported data on viral load, patients’ symptom status, sample type, and PCR assay used were included. 19 studies utilizing 11,109 samples with 2,509 RT-PCR-positives were included. RAT sensitivity varied between 28.9% (95% CI 16.4–44.3) and 98.3% (95% CI 91.1–99.7), likely dependent upon population characteristics, viral load, and symptom status. RAT specificity varied between 92.4% (95% CI 87.4–95.9) and 100% (95% CI 99.7–100) with one outlier. The RATs by Roche Diagnostics/SD Biosensor and Abbott had the highest pooled sensitivity (82.4% [95% CI 74.2–88.4] and 76.9% [95% CI 72.1–81.2], respectively). Sensitivity in high-viral-load samples (cycle threshold ≤25) showed heterogeneity among the different RATs. The RATs offered by Roche Diagnostics/SD Biosensor and Abbott provide sufficient manufacturer-independent, real-world performance data to support their use to detect current SARS-CoV-2 infection, particularly in high-viral-load populations.
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影响因子：
4.8
作者：
Chaimayo C;Kaewnaphan B;Tanlieng N;Athipanyasilp N;Sirijatuphat R;Chayakulkeeree M;Angkasekwinai N;Sutthent R;Puangpunngam N;Tharmviboonsri T;Pongraweewan O;Chuthapisith S;Sirivatanauksorn Y;Kantakamalakul W;Horthongkham N
通讯作者：
Horthongkham N
影响因子：
11.8
作者：
Bullard, Jared;Dust, Kerry;Poliquin, Guillaume
通讯作者：
Poliquin, Guillaume
影响因子：
2
作者：
Rutter, CM;Gatsonis, CA
通讯作者：
Gatsonis, CA
影响因子：
3.1
作者：
Krüttgen A;Cornelissen CG;Dreher M;Hornef MW;Imöhl M;Kleines M
通讯作者：
Kleines M
影响因子：
7.2
作者：
Reitsma, JB;Glas, AS;Zwinderman, AH
通讯作者：
Zwinderman, AH