Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia.
Victorian Infectious Diseases Reference Laboratory, Melbourne Health at the Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia.
Pathology. 2022 Aug;54(5):623-628. doi: 10.1016/j.pathol.2022.04.001. Epub 2022 Jun 29.
During the COVID-19 pandemic, the reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) assay has been the primary method of diagnosis of SARS-CoV-2 infection. However, RT-qPCR assay interpretation can be ambiguous with no universal absolute cut-off value to determine sample positivity, which particularly complicates the analysis of samples with high Ct values, or weak positives. Therefore, we sought to analyse factors associated with weak positive SARS-CoV-2 diagnosis. We analysed sample data associated with all positive SARS-CoV-2 RT-qPCR diagnostic tests performed by the Victorian Infectious Diseases Reference Laboratory (VIDRL) in Melbourne, Australia, during the Victorian first wave (22 January 2020-30 May 2020). A subset of samples was screened for the presence of host DNA and RNA using qPCR assays for CCR5 and 18S, respectively. Assays targeting the viral RNA-dependent RNA polymerase (RdRp) had higher Ct values than assays targeting the viral N and E genes. Weak positives were not associated with the age or sex of individuals' samples nor with reduced levels of host DNA and RNA. We observed a relationship between Ct value and time post-SARS-CoV-2 diagnosis. High Ct value or weak positive SARS-CoV-2 was not associated with any particular bias including poor biological sampling.
在 COVID-19 大流行期间,逆转录-定量聚合酶链反应 (RT-qPCR) 检测已成为 SARS-CoV-2 感染诊断的主要方法。然而,RT-qPCR 检测结果的解读可能存在歧义,没有普遍的绝对截止值来确定样本的阳性,这尤其使得高 Ct 值或弱阳性样本的分析变得复杂。因此,我们试图分析与 SARS-CoV-2 弱阳性诊断相关的因素。我们分析了与澳大利亚墨尔本维多利亚传染病参考实验室 (VIDRL) 在维多利亚第一波疫情(2020 年 1 月 22 日至 5 月 30 日)期间进行的所有 SARS-CoV-2 RT-qPCR 诊断检测呈阳性的样本相关数据。使用针对 CCR5 和 18S 的 qPCR 检测分别对样本中宿主 DNA 和 RNA 的存在进行了筛选。针对病毒 RNA 依赖性 RNA 聚合酶 (RdRp) 的检测的 Ct 值高于针对病毒 N 和 E 基因的检测。弱阳性与个体样本的年龄或性别无关,也与宿主 DNA 和 RNA 水平降低无关。我们观察到 Ct 值与 SARS-CoV-2 诊断后时间之间存在关系。高 Ct 值或弱阳性 SARS-CoV-2 与任何特定偏倚均无关,包括采样不佳。