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Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand
Virology Journal ( IF 4.8 ) Pub Date : 2020-11-13 , DOI: 10.1186/s12985-020-01452-5
Chutikarn Chaimayo , Bualan Kaewnaphan , Nattaya Tanlieng , Niracha Athipanyasilp , Rujipas Sirijatuphat , Methee Chayakulkeeree , Nasikarn Angkasekwinai , Ruengpung Sutthent , Nattawut Puangpunngam , Theerawoot Tharmviboonsri , Orawan Pongraweewan , Suebwong Chuthapisith , Yongyut Sirivatanauksorn , Wannee Kantakamalakul , Navin Horthongkham

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.

中文翻译:

快速SARS-CoV-2抗原检测测定与实时RT-PCR测定相比较在泰国实验室诊断COVID-19

2019年冠状病毒病(COVID-19)大流行继续在全球蔓延。因此,迫切需要快速,简单和准确的测试以诊断严重的急性呼吸系统综合症冠状病毒2(SARS-CoV-2)感染。应评估SARS-CoV-2抗原快速检测测试的性能特征,并将其与黄金标准实时逆转录聚合酶链反应(RT-PCR)测试相比较,以诊断COVID-19病例。快速SARS-CoV-2抗原检测试验Standard™Q COVID-19 Ag试剂盒(大韩民国SDBiosensor®)与实时RT-PCR试验Allplex™2019-nCoV测定法(Seegene® (韩国)检测呼吸道标本中的SARS-CoV-2。于2020年3月至5月期间,从泰国曼谷Siriraj医院的COVID-19疑似病例和接触者(包括术前患者)获得了454份呼吸道样本(主要是鼻咽和咽拭子)。在454份呼吸道样本中,有60份实时RT-PCR分析显示SARS-CoV-2 RNA(13.2%)呈阳性,而394(86.8%)呈阴性。从可疑病例COVID-19的发作到实验室检查的持续时间为0到14天,中位数为3天。快速SARS-CoV-2抗原检测试验的敏感性和特异性分别为98.33%(95%CI,91.06-99.96%)和98.73%(95%CI,97.06-99.59%)。一个假阴性测试结果来自实时RT-PCR循环阈值(Ct)高的样品,术前患者标本中有五个假阳性结果。SARS-CoV-2抗原检测的快速测定法显示出与实时RT-PCR测定法相当的灵敏度和特异性。因此,这种快速而简单的SARS-CoV-2抗原检测试验作为筛选试验有潜在的用途。
更新日期:2020-11-15
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