Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand.
Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand.
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DOI：
10.1186/s12985-020-01452-5
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发表时间：
2020-11-13
期刊：
影响因子：
4.8
通讯作者：
Horthongkham N
中科院分区：
文献类型：
--
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
2019冠状病毒病（COVID-19）大流行继续在全球蔓延。因此，迫切需要一种快速、简单、准确的检测方法来诊断严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）感染。应评价SARS-CoV-2抗原快速检测试验的性能特点，并与实时逆转录聚合酶链反应（RT-PCR）金标准检测方法进行比较，以诊断COVID-19病例。将快速SARS-CoV-2抗原检测试剂盒Standard™Q COVID-19 Ag kit （SD Biosensor®，韩国）与实时RT-PCR检测试剂盒Allplex™2019-nCoV Assay （Seegene®，韩国）用于检测呼吸道标本中的SARS-CoV-2进行比较。从2019冠状病毒病疑似病例和接触者（包括2020年3月至5月期间在泰国曼谷Siriraj医院的术前患者）获取了454份呼吸道样本（主要是鼻咽和咽拭子）。实时RT-PCR检测454份呼吸道标本中，60份（13.2%）呈阳性，394份（86.8%）呈阴性。COVID-19疑似病例和接触者从发病到实验室检测的时间为0至14天，中位数为3天。SARS-CoV-2抗原快速检测试验的灵敏度和特异性分别为98.33% （95% CI, 91.06 ~ 99.96%）和98.73% （95% CI, 97.06 ~ 99.59%）。1例假阴性检测结果来自实时RT-PCR周期阈值（Ct）较高的标本，5例假阳性检测结果来自术前患者标本。SARS-CoV-2抗原快速检测与实时RT-PCR检测具有相当的敏感性和特异性。因此，有可能使用这种快速和简单的SARS-CoV-2抗原检测试验作为筛选试验。
The Coronavirus disease 2019 (COVID-19) pandemic continues to spread across the world. Hence, there is an urgent need for rapid, simple, and accurate tests to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Performance characteristics of the rapid SARS-CoV-2 antigen detection test should be evaluated and compared with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) test for diagnosis of COVID-19 cases. The rapid SARS-CoV-2 antigen detection test, Standard™ Q COVID-19 Ag kit (SD Biosensor®, Republic of Korea), was compared with the real-time RT-PCR test, Allplex™ 2019-nCoV Assay (Seegene®, Korea) for detection of SARS-CoV-2 in respiratory specimens. Four hundred fifty-four respiratory samples (mainly nasopharyngeal and throat swabs) were obtained from COVID-19 suspected cases and contact individuals, including pre-operative patients at Siriraj Hospital, Bangkok, Thailand during March–May 2020. Of 454 respiratory samples, 60 (13.2%) were positive, and 394 (86.8%) were negative for SARS-CoV-2 RNA by real-time RT-PCR assay. The duration from onset to laboratory test in COVID-19 suspected cases and contact individuals ranged from 0 to 14 days with a median of 3 days. The rapid SARS-CoV-2 antigen detection test’s sensitivity and specificity were 98.33% (95% CI, 91.06–99.96%) and 98.73% (95% CI, 97.06–99.59%), respectively. One false negative test result was from a sample with a high real-time RT-PCR cycle threshold (Ct), while five false positive test results were from specimens of pre-operative patients. The rapid assay for SARS-CoV-2 antigen detection showed comparable sensitivity and specificity with the real-time RT-PCR assay. Thus, there is a potential use of this rapid and simple SARS-CoV-2 antigen detection test as a screening assay.
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