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Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens.

Accula SARS-CoV-2检测与实验室开发的检测临床鼻咽标本中SARS-CoV-2 RNA的比较。

  • 影响因子:3.65
  • DOI:10.1128/JCM.01072-20
  • 作者列表:"Hogan CA","Garamani N","Lee AS","Tung JK","Sahoo MK","Huang C","Stevens B","Zehnder J","Pinsky BA
  • 发表时间:2020-07-23
Abstract

: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.

摘要

: 一些即时 (POC) 分子测试已经获得了食品和药物管理局 (FDA) 的紧急使用授权 (EUA),用于诊断新型冠状病毒 (SARS-CoV-2)。需要评估Accula (Mesa Biotech) SARS-CoV-2 POC测试的测试性能特征,以告知其最佳用途。本研究的目的是评估Accula SARS-CoV-2测试的测试性能。通过比较先前由Stanford Health Care EUA实验室开发的针对包膜 (E) 基因的测试 (shc-ldt) 表征的100个鼻咽拭子样品的结果来评估Accula测试的性能。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 kappa系数评估试验一致性。试验之间的总体一致性百分比为84.0% (95% 置信区间 [CI],75.3至90.6%),PPA为68.0% (95% CI,53.3至80.5%),kappa系数为0.68 (95% CI,0.54至0.82)。通过shc-ldt检测到的16个样本没有通过Accula测试检测到,并且显示低病毒载量,中值周期阈值为37.7。NPA为100% (95% CI,94.2 ~ 100%)。与shc-ldt相比,Accula SARS-CoV-2测试显示出极好的阴性一致性。然而,阳性协议是低病毒载量低的样品。Accula POC测试的假阴性率要求对临床环境中的POC测试性能特征进行更彻底的评估,并在Accula测试阴性的中度至高测试前概率为SARS-CoV-2的个体中进行验证性测试。

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影响因子:0.85
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来源期刊:Laboratory medicine
DOI:10.1093/labmed/lmz030
作者列表:["Yang R","Zhang R","Zhang Y","Huang Y","Liang H","Gui G","Gong S","Wang H","Xu M","Fan J"]

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影响因子:4.51
发表时间:2020-01-01
DOI:10.1016/j.cmi.2019.05.010
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分子诊断技术方向

分子诊断技术是指以DNA和RNA为诊断材料,用分子生物学技术通过检测基因的存在、缺陷或表达异常,从而对人体状态和疾病作出诊断的技术。

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