Differences in Performance Characteristics Among Four High-Throughput Assays for the Detection of Antibodies Against SARS-CoV-2 Using a Common Set of Patient Samples.
Differences in Performance Characteristics Among Four High-Throughput Assays for the Detection of Antibodies Against SARS-CoV-2 Using a Common Set of Patient Samples.
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DOI：
10.1093/ajcp/aqaa200
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发表时间：
2021-02-04
影响因子：
3.5
通讯作者：
Gherasim C
中科院分区：
文献类型：
--
作者：
Manthei DM;Whalen JF;Schroeder LF;Sinay AM;Li SH;Valdez R;Giacherio DA;Gherasim C
严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的血清学检测经历了可用检测方法的不断变化以及性能特征的不确定性。需要研究来直接比较多种市售检测方法。根据 SARS-CoV-2 逆转录聚合酶链反应 (RT-PCR) 检测、临床检测结果和采集日期对残留血清样本进行了鉴定。使用来自四个不同制造商的检测方法对血清样本进行分析：DiaSorin 抗 SARS-CoV-2 S1/S2 IgG、EUROIMUN 抗 SARS-CoV-2 IgG ELISA、Roche Elecsys 抗 SARS-CoV-2 和西门子 SARS-CoV-2 总抗体检测。随着症状出现时间的延长，来自 SARS-CoV-2 RT-PCR 阳性患者的样本变得越来越呈阳性。对于症状出现后 14 天或更长时间采集最新样本的患者，EUROMMUN、罗氏和西门子检测的敏感性分别达到 93.1% 至 96.6%、98.3% 和 96.6%，优于 DiaSorin 检测的 87.7%。罗氏和西门子检测的特异性为 100%，优于 DiaSorin 和 EUROIMMUN 检测，分别为 96.1% 至 97.0% 和 86.3% 至 96.4%。实验室应了解 SARS-CoV-2 血清学检测方案的优点和局限性。罗氏和西门子检测所达到的特异性和灵敏度对于低流行地区的检测来说是可以接受的，并且如果组合使用，则具有潜在的正交检测优势。
Serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has experienced a changing landscape of available assays coupled with uncertainty surrounding performance characteristics. Studies are needed to directly compare multiple commercially available assays. Residual serum samples were identified based on SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) testing, clinical test results, and collection dates. Serum samples were analyzed using assays from four different manufacturers: DiaSorin anti–SARS-CoV-2 S1/S2 IgG, EUROIMMUN anti–SARS-CoV-2 IgG ELISA, Roche Elecsys anti–SARS-CoV-2, and Siemens SARS-CoV-2 Total antibody assays. Samples from SARS-CoV-2 RT-PCR–positive patients became increasingly positive as time from symptom onset increased. For patients with latest sample 14 or more days after symptom onset, sensitivities reached 93.1% to 96.6%, 98.3%, and 96.6% for EUROIMMUN, Roche, and Siemens assays, respectively, which were superior to the DiaSorin assay at 87.7%. The specificity of Roche and Siemens assays was 100% and superior to DiaSorin and EUROIMMUN assays, which ranged from 96.1% to 97.0% and 86.3% to 96.4%, respectively. Laboratories should be aware of the advantages and limitations of serology testing options for SARS-CoV-2. The specificity and sensitivity achieved by the Roche and Siemens assays would be acceptable for testing in lower-prevalence regions and have the potential of orthogonal testing advantages if used in combination.
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影响因子：
82.9
作者：
Long, Quan-Xin;Liu, Bai-Zhong;Huang, Ai-Long
通讯作者：
Huang, Ai-Long
影响因子：
8.8
作者：
Pflueger, Lisa Sophie;Bannasch, Johannes H.;Luetgehetmann, Marc
通讯作者：
Luetgehetmann, Marc
影响因子：
82.9
作者：
Amanat F;Stadlbauer D;Strohmeier S;Nguyen THO;Chromikova V;McMahon M;Jiang K;Arunkumar GA;Jurczyszak D;Polanco J;Bermudez-Gonzalez M;Kleiner G;Aydillo T;Miorin L;Fierer DS;Lugo LA;Kojic EM;Stoever J;Liu STH;Cunningham-Rundles C;Felgner PL;Moran T;García-Sastre A;Caplivski D;Cheng AC;Kedzierska K;Vapalahti O;Hepojoki JM;Simon V;Krammer F
通讯作者：
Krammer F
影响因子：
8.8
作者：
Beavis, Kathleen G.;Matushek, Scott M.;Tesic, Vera
通讯作者：
Tesic, Vera
影响因子：
9.4
作者：
Charlton CL;Kanji JN;Johal K;Bailey A;Plitt SS;MacDonald C;Kunst A;Buss E;Burnes LE;Fonseca K;Berenger BM;Schnabl K;Hu J;Stokes W;Zelyas N;Tipples G
通讯作者：
Tipples G