当前位置:
X-MOL 学术
›
J. Clin. Microbiol.
›
论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Evaluation of Serological SARS-CoV-2 Lateral Flow Assays for Rapid Point-of-Care Testing
Journal of Clinical Microbiology ( IF 9.4 ) Pub Date : 2021-01-21 , DOI: 10.1128/jcm.02020-20 Steven E. Conklin 1 , Kathryn Martin 1 , Yukari C. Manabe 2 , Haley A. Schmidt 1 , Jernelle Miller 1 , Morgan Keruly 3 , Ethan Klock 2 , Charles S. Kirby 1 , Owen R. Baker 3 , Reinaldo E. Fernandez 2 , Yolanda J. Eby 1 , Justin Hardick 2 , Kathryn Shaw-Saliba 4 , Richard E. Rothman 4 , Patrizio P. Caturegli 1 , Andrew D. Redd 2, 3 , Aaron A. R. Tobian 1, 2 , Evan M. Bloch 1 , H. Benjamin Larman 1 , Thomas C. Quinn 2, 3 , William Clarke 1 , Oliver Laeyendecker 2, 3
Journal of Clinical Microbiology ( IF 9.4 ) Pub Date : 2021-01-21 , DOI: 10.1128/jcm.02020-20 Steven E. Conklin 1 , Kathryn Martin 1 , Yukari C. Manabe 2 , Haley A. Schmidt 1 , Jernelle Miller 1 , Morgan Keruly 3 , Ethan Klock 2 , Charles S. Kirby 1 , Owen R. Baker 3 , Reinaldo E. Fernandez 2 , Yolanda J. Eby 1 , Justin Hardick 2 , Kathryn Shaw-Saliba 4 , Richard E. Rothman 4 , Patrizio P. Caturegli 1 , Andrew D. Redd 2, 3 , Aaron A. R. Tobian 1, 2 , Evan M. Bloch 1 , H. Benjamin Larman 1 , Thomas C. Quinn 2, 3 , William Clarke 1 , Oliver Laeyendecker 2, 3
Affiliation
Rapid point-of-care tests (POCTs) for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies vary in performance. A critical need exists to perform head-to-head comparisons of these assays. The performances of 15 different lateral flow POCTs for the detection of SARS-CoV-2-specific antibodies were compared on a well-characterized set of 100 samples. Of these, 40 samples from known SARS-CoV-2-infected, convalescent individuals (collected an average of 45 days after symptom onset) were used to assess sensitivity. Sixty samples from the prepandemic era (negative control) that were known to represent infections with other respiratory viruses (rhinoviruses A, B, and C and/or coronavirus 229E, HKU1, and NL63 OC43) were used to assess specificity. The timing of seroconversion was assessed using five lateral flow assays (LFAs) and a panel of 272 longitudinal samples from 47 patients for whom the time since symptom onset was known. Among the assays that were evaluated, the sensitivity and specificity for any reactive band ranged from 55% to 97% and from 78% to 100%, respectively. Assessing the performance of the IgM and the IgG bands alone, sensitivity and specificity ranged from 0% to 88% and 80% to 100% for IgM and from 25% to 95% and 90% to 100% for IgG, respectively. Longitudinal testing revealed that the median times after symptom onset to a positive result were 7 days (interquartile range [IQR], 5.4 to 9.8) for IgM and 8.2 days (IQR, 6.3 to 11.3) for IgG. The testing performances differed widely among LFAs, with greatest amount of variation related to the sensitivity of the assays. The IgM band was the band most likely to misclassify prepandemic samples. The appearances of IgM and IgG bands occurred almost simultaneously.
中文翻译:
血清SARS-CoV-2侧向流动检测法对快速护理点检测的评估
用于检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)特异性抗体的快速即时检测(POCT)在性能上有所不同。迫切需要对这些测定法进行直接比较。在一组特征鲜明的100个样品上比较了15种不同的侧向POCT检测SARS-CoV-2特异性抗体的性能。其中,从已知的SARS-CoV-2感染恢复期个体中收集40个样本(症状发作后平均45天收集),以评估敏感性。使用大流行前时代(阴性对照)的60个样本来评估特异性,这些样本代表了其他呼吸道病毒(鼻病毒A,B和C和/或冠状病毒229E,HKU1和NL63 OC43)的感染。使用五种侧向流动测定法(LFA)和一组来自47位患者的272个纵向样品进行评估,评估血清转换的时间,这些患者自症状发作以来的时间已知。在所评估的测定中,任何反应谱带的灵敏度和特异性分别为55%至97%和78%至100%。仅评估IgM和IgG条带的性能,对IgM的敏感性和特异性分别为0%至88%和80%至100%,对于IgG分别为25%至95%和90%至100%。纵向测试显示,症状发作至阳性结果的中位时间对于IgM为7天(四分位间距[IQR],5.4至9.8),对于IgG为8.2天(IQR,6.3至11.3)。LFA之间的测试性能差异很大,与测定灵敏度相关的变化最大。IgM频段是最有可能对大流行前样本进行错误分类的频段。IgM和IgG条带的出现几乎同时发生。
更新日期:2021-01-21
中文翻译:
血清SARS-CoV-2侧向流动检测法对快速护理点检测的评估
用于检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)特异性抗体的快速即时检测(POCT)在性能上有所不同。迫切需要对这些测定法进行直接比较。在一组特征鲜明的100个样品上比较了15种不同的侧向POCT检测SARS-CoV-2特异性抗体的性能。其中,从已知的SARS-CoV-2感染恢复期个体中收集40个样本(症状发作后平均45天收集),以评估敏感性。使用大流行前时代(阴性对照)的60个样本来评估特异性,这些样本代表了其他呼吸道病毒(鼻病毒A,B和C和/或冠状病毒229E,HKU1和NL63 OC43)的感染。使用五种侧向流动测定法(LFA)和一组来自47位患者的272个纵向样品进行评估,评估血清转换的时间,这些患者自症状发作以来的时间已知。在所评估的测定中,任何反应谱带的灵敏度和特异性分别为55%至97%和78%至100%。仅评估IgM和IgG条带的性能,对IgM的敏感性和特异性分别为0%至88%和80%至100%,对于IgG分别为25%至95%和90%至100%。纵向测试显示,症状发作至阳性结果的中位时间对于IgM为7天(四分位间距[IQR],5.4至9.8),对于IgG为8.2天(IQR,6.3至11.3)。LFA之间的测试性能差异很大,与测定灵敏度相关的变化最大。IgM频段是最有可能对大流行前样本进行错误分类的频段。IgM和IgG条带的出现几乎同时发生。