比较两种商业检测方法在低病毒载量样品中检测SARS-CoV-2的性能

IF 1.4
Kok Siong Poon, N. Tee
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引用次数: 0

摘要

安全解除隔离。我们最近审查了实验室在2020年6月至7月期间收到的24份连续鼻咽拭子样本的Ct值,这些样本通过cobas®检测出严重急性呼吸系统综合征冠状病毒2型RNA推定阳性(E基因靶点阳性,但ORF1a基因靶点阴性)。这些样本的临界病毒滴度接近检测限(LOD)(100拷贝/mL)(3),如其高Ct值所示。这些样本在同一天内使用Xpert®Xpress严重急性呼吸系统综合征冠状病毒2型测定法进行了重新测试。该测定法检测N2和E基因靶标。与cobas®检测的报告算法类似,Xpert®检测仅检测到E基因的样本被视为推定阳性,建议重新检测(Xpert™Xpress严重急性呼吸系统综合征冠状病毒2型检测包插件)。Wolters等人确定Xpert®测定的LOD为8.26拷贝/mL(4)。24个cobas试验推定阳性样本,17个E和N2基因Ct值为E基因,目标Ct值是E和N2两个基因,它们使用Xpert®测定法进行检测。观察到的两种测定的E基因靶标的Ct值非常一致,具有高标准随机效应,这是一个显著的观察结果,因为在检查低
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparing the performance of two commercial assays for detection of SARS-CoV-2 in samples with low viral load
be safely discharged from isolation. We recently reviewed the Ct values from 24 consecutive nasopharyngeal swab samples received between June and July 2020 by the laboratory with presumptive positive SARS-CoV-2 RNA by cobas ® (a positive result for the E gene target but a negative result for the ORF1a gene target). These are specimens with a borderline viral titre close to the assay’s limit of detection (LOD) (100 copies/mL) (3) as indicated by their high Ct values. These samples were re-tested within the same day using the Xpert ® Xpress SARS-Cov-2 assay. This assay detects the N2 and E gene targets. Similar to the reporting algorithm of the cobas ® test, samples with only detectable E gene by the Xpert ® assay are considered as presumptive positive with recommendation for re-testing (Xpert ® Xpress SARS-Cov-2 assay package insert). The LOD of Xpert ® assay was determined by Wolters et al. to be 8.26 copies/mL (4). 24 presumptive positive samples by cobas test, 17 E and N2 gene Ct value for E gene target Ct value for gene for both E and N2 gene they were tested using the Xpert ® assay. Close agreement between the Ct values of E gene target of the two assays observed, with a high standard Stochastic effect, which is a prominent observation due to random variations when examining low
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CiteScore
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