Sample-to-Answer and Routine Real-Time RT-PCR: A Comparison of Different Platforms for SARS-CoV-2 Detection.
Sample-to-Answer and Routine Real-Time RT-PCR: A Comparison of Different Platforms for SARS-CoV-2 Detection.
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DOI：
10.1016/j.jmoldx.2021.02.010
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发表时间：
2021-06
期刊：
影响因子：
--
通讯作者：
Wu W
中科院分区：
文献类型：
--
作者：
Wen D;Yang S;Li G;Xuan Q;Guo W;Wu W
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）正在全球范围内蔓延，并已造成数百万人死亡。包括Cepheid Xpert Xpress SARS-CoV-2（Xpert Xpress）在内的多个样本即应答平台已获得紧急使用授权，可在美国进行SARS-CoV-2核酸检测，作为床旁检测。然而，与中国国家药品监督管理局批准的实时RT-PCR检测相比，其应用领域尚不清楚。本研究采用86例有症状患者的标本，评价Xpert Xpress和两种实时RT-PCR试剂盒（BioGerm试剂盒和Sansure试剂盒）的临床性能、灵敏度和工作流程。Xpert Xpress的阳性一致率为100%，BioGerm试剂盒为96.15%，Sansure试剂盒为90%。所有三种检测的阴性一致率均为100%。Xpert Xpress的检测限为100拷贝/mL，BioGerm试剂盒和Sansure试剂盒的检测限为500拷贝/mL。通过连续稀释5份阳性标本，Xpert Xpress具有更好的检测能力。在工作流程和通量分析中，Xpert Xpress的周转时间为51分钟，BioGerm试剂盒为150分钟，Sansure试剂盒为210分钟。本研究为诊断方法的选择提供了一定的参考依据。
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is spreading all over the world and has caused millions of deaths. Several sample-to-answer platforms, including Cepheid Xpert Xpress SARS-CoV-2 (Xpert Xpress), have received emergency use authorization for SARS-CoV-2 nucleic acid detection as a point of care test in the United States. However, their application niche is unclear when compared with real-time RT-PCR assays cleared by the National Medical Products Administration in China. In this study, the clinical performance, sensitivity, and workflow of Xpert Xpress and two real-time RT-PCR kits (BioGerm kit and Sansure kit) were evaluated by the specimens from 86 symptomatic patients. The positive percent agreement of Xpert Xpress was 100% compared with 96.15% for the BioGerm kit and 90% for the Sansure kit. The negative percent agreement was 100% for all three assays. The limit of detection is 100 copies/mL for Xpert Xpress and 500 copies/mL for the BioGerm kit and Sansure kit. By serially diluting five positive specimens, the Xpert Xpress had better detection capability. In the workflow and throughput analysis, the turnaround time was 51 minutes for Xpert Xpress, 150 minutes for the BioGerm kit, and 210 minutes for the Sansure kit. This study provides some indication for diagnosis methods selection.
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