比较评估赛沛 Xpert® Xpress SARS-CoV-2 检测试剂盒与罗氏 TaqPathTM COVID-19 Combo 试剂盒检测鼻咽拭子中 SARS-CoV-2 的效果。
Comparative evaluation of the Thermo fisher TaqPath™ COVID-19 combo kit with the Cepheid Xpert® Xpress SARS-CoV-2 assay for detecting SARS-CoV-2 in nasopharyngeal specimens.
机构信息
Microbiology Department, Laboratory Alliance of Central New York, Liverpool, New York, USA.
Department of Pathology, SUNY Upstate Medical University, Syracuse, New York, USA.
出版信息
BMC Infect Dis. 2021 Jun 30;21(1):623. doi: 10.1186/s12879-021-06347-6.
PURPOSE
With over 50 SARS-CoV-2 gene amplification assays that have been EUA cleared with minimal experimental validation performed, it is likely that not all of these assays are comparable in their ability to detect SARS-CoV-2 in clinical specimens. Thermo Fisher Scientific is a relatively new company in the molecular diagnostics field and the purpose of this study was to compare the performance of the Thermo Fisher TaqPath™ Combo Kit with an established test, the Cepheid Xpert® Xpress SARS-CoV-2 assay, for its ability to detect SARS-CoV-2 in nasopharyngeal specimens.
METHODS
A total of 300 randomly selected nasopharyngeal specimens were evaluated and tested by the TaqPath and GeneXpert assays. Discordant test specimens were arbitrated by performing an alternative PCR assay and Sanger sequencing.
RESULTS
The TaqPath assay had a 96.7 and 99.6% positive and negative agreement respectively when compared to the Xpert Xpress test. However, after test arbitration, the three discordant specimens were arbitrated in favor of the TaqPath assay producing a positive and negative percent agreement of 100% for the TaqPath Combo Kit while the Xpress SARS-CoV-2 assay had a positive and negative percent agreement of 98.3 and 99.2% respectively.
CONCLUSIONS
The TaqPath Combo Kit is a high complexity assay that compares favorably with the Xpert Xpress test and can be reliably used for the detection of SARS-CoV-2 in nasopharyngeal specimens.
目的
已有超过 50 种 SARS-CoV-2 基因扩增检测试剂获得 EUA 批准，这些试剂的实验验证工作很少，因此很可能它们在检测临床标本中的 SARS-CoV-2 方面的能力并不完全可比。赛沛公司是分子诊断领域的一家相对较新的公司，本研究的目的是比较赛沛 Xpert® Xpress SARS-CoV-2 检测与 Thermo Fisher Scientific 的 TaqPath™ Combo 试剂盒在检测鼻咽拭子中 SARS-CoV-2 方面的性能。
方法
共评估并检测了 300 份随机选择的鼻咽拭子标本，使用 TaqPath 和 GeneXpert 试剂盒进行检测。对有分歧的检测标本进行仲裁，通过进行替代 PCR 检测和 Sanger 测序。
结果
与 Xpert Xpress 检测相比，TaqPath 检测的阳性和阴性符合率分别为 96.7%和 99.6%。然而，经过检测仲裁，三个有分歧的标本仲裁结果有利于 TaqPath 检测，TaqPath Combo 试剂盒的阳性和阴性符合率为 100%，而 Xpress SARS-CoV-2 检测的阳性和阴性符合率分别为 98.3%和 99.2%。
结论
TaqPath Combo 试剂盒是一种高复杂度的检测试剂，与 Xpert Xpress 检测相比具有优势，可以可靠地用于检测鼻咽拭子中的 SARS-CoV-2。
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