Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens
Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens
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DOI：
10.1128/jcm.01072-20
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发表时间：
2020-08-01
影响因子：
9.4
通讯作者：
Pinsky, Benjamin A.
中科院分区：
文献类型：
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作者：
Hogan, Catherine A.;Garamani, Natasha;Pinsky, Benjamin A.
一些即时护理（POC）分子检测已获得美国食品和药物管理局（FDA）的紧急使用授权（EUA），用于诊断严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）。需要对Accula (Mesa Biotech) SARS-CoV-2 POC测试的测试性能特征进行评估，以确定其最佳使用方法。本研究的目的是评估积累SARS-CoV-2测试的测试性能。Accula测试的性能是通过比较100个鼻咽拭子样本的结果来评估的，这些样本之前由斯坦福大学卫生保健EUA实验室开发的测试（SHC-LDT）表征，靶向包膜(E)基因。测定一致性通过总体一致性百分比、阳性一致性百分比（PPA）、阴性一致性百分比（NPA）和Cohen’s kappa系数来评估。两种测定法的总体一致性为84.0%(95%可信区间[CI]， 75.3 ~ 90.6%)， PPA为68.0% (95% CI, 53.3 ~ 80.5%)， kappa系数为0.68 （95% CI, 0.54 ~ 0.82）。16例SHC-LDT检测到的标本未被Accula试验检测到，病毒载量负荷较低，周期阈值中位数为37.7。NPA为100% （95% CI, 94.2 ~ 100%）。与SHC-LDT相比，积累SARS-CoV-2试验显示出极好的阴性一致性。然而，对于病毒载量较低的样本，阳性一致性较低。acula POC检测的假阴性率要求对临床环境中POC检测的性能特征进行更彻底的评估，并对acula检测呈阴性的SARS-CoV-2预测概率中等至高的个体进行确证性检测。
Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. The aim of this study was to assess the test performance of the Accula SARS-CoV-2 test. The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT), targeting the envelope (E) gene. Assay concordance was assessed by overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), and Cohen's kappa coefficient. Overall percent agreement between the assays was 84.0% (95% confidence interval [CI], 75.3 to 90.6%), PPA was 68.0% (95% CI, 53.3 to 80.5%), and the kappa coefficient was 0.68 (95% CI, 0.54 to 0.82). Sixteen specimens detected by the SHC-LDT were not detected by the Accula test and showed low viral load burden, with a median cycle threshold value of 37.7. NPA was 100% (95% CI, 94.2 to 100%). Compared to the SHC-LDT, the Accula SARS-CoV-2 test showed excellent negative agreement. However, positive agreement was low for samples with low viral load. The false-negative rate of the Accula POC test calls for a more thorough evaluation of POC test performance characteristics in clinical settings and for confirmatory testing in individuals with moderate to high pretest probability of SARS-CoV-2 who test negative on Accula.