Clinical Evaluation of BD Veritor SARS-CoV-2 Point-of-Care Test Performance Compared to PCR-Based Testing and versus the Sofia 2 SARS Antigen Point-of-Care Test.
Clinical Evaluation of BD Veritor SARS-CoV-2 Point-of-Care Test Performance Compared to PCR-Based Testing and versus the Sofia 2 SARS Antigen Point-of-Care Test.
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DOI：
10.1128/jcm.02338-20
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发表时间：
2020-12-17
影响因子：
9.4
通讯作者：
Cooper CK
中科院分区：
文献类型：
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作者：
Young S;Taylor SN;Cammarata CL;Varnado KG;Roger-Dalbert C;Montano A;Griego-Fullbright C;Burgard C;Fernandez C;Eckert K;Andrews JC;Ren H;Allen J;Ackerman R;Cooper CK
用于快速检测 SARS-CoV-2 核衣壳抗原的 BD Veritor 系统 (Veritor) 是一种用于 SARS-CoV-2 护理点检测的色谱免疫分析方法，使用具有 COVID-19 症状的个体的鼻腔标本评估了其临床性能。完成了两项研究以确定临床表现。在第一项研究中，使用来自 251 名有 COVID-19 症状的参与者（症状出现后≤7 天 [DSO]，年龄≥18 岁）的鼻标本以及鼻咽或口咽标本来比较 Veritor 与 Lyra SARS-CoV-2 PCR 检测 (Lyra)。用于快速检测 SARS-CoV-2 核衣壳抗原的 BD Veritor 系统 (Veritor) 是一种用于 SARS-CoV-2 护理点检测的色谱免疫分析方法，使用具有 COVID-19 症状的个体的鼻腔标本评估了其临床性能。完成了两项研究以确定临床表现。在第一项研究中，使用来自 251 名有 COVID-19 症状的参与者（症状出现后≤7 天 [DSO]，年龄≥18 岁）的鼻标本以及鼻咽或口咽标本来比较 Veritor 与 Lyra SARS-CoV-2 PCR 检测 (Lyra)。在第二项研究中，利用来自 361 名有 COVID-19 症状的参与者（≤ 5 DSO，≥ 18 岁）的鼻标本来比较 Veritor 与 Sofia 2 SARS 抗原 FIA 测试 (Sofia 2) 的性能。积极、消极和总体一致性百分比（分别为 PPA、NPA 和 OPA）是主要结果。在研究 1 中，与 Lyra 相比，Veritor 的 PPA 在 0 到 1 和 0 到 6 DSO 范围内为 81.8% 到 87.5%。在研究 2 中，Veritor 与 Sofia 2 的 PPA、NPA 和 OPA 值分别为 97.4、98.1 和 98.1%。不一致的分析显示 Veritor 遗漏了 1 个 Lyra 阳性，Sofia 2 遗漏了 5 个 Lyra 阳性； Veritor 的一项阳性结果是 Lyra 的阴性结果。 Veritor 符合 FDA 对 0 至 5 和 0 至 6 DSO 范围的 SARS-CoV-2 抗原检测的紧急使用授权 (EUA) 接受标准（PPA 值分别为 83.9% 和 82.4%）。 Veritor 和 Sofia 2 在 SARS-CoV-2 检测方面表现出高度一致。 Veritor 测试可以利用易于采集的鼻拭子进行更快速的 COVID-19 测试，但与 PCR 相比，PPA 低于 100%。
The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra). The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO, ≥18 years of age) were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). The positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. In study 1, the PPA for Veritor, compared to Lyra, ranged from 81.8 to 87.5% across the 0 to 1 and 0 to 6 DSO ranges. In study 2, Veritor had PPA, NPA, and OPA values of 97.4, 98.1, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Veritor met FDA emergency use authorization (EUA) acceptance criteria for SARS-CoV-2 antigen testing for the 0 to 5 and 0 to 6 DSO ranges (PPA values of 83.9% and 82.4%, respectively). Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs but demonstrated <100% PPA compared to PCR.