Biology Faculty, Technion-Israel Institute of Technology, Haifa, Israel.
Biology Faculty, Technion-Israel Institute of Technology, Haifa, Israel.
J Mol Diagn. 2022 Feb;24(2):112-119. doi: 10.1016/j.jmoldx.2021.10.010. Epub 2021 Nov 23.
Quantifying the detection rate of the widely used quantitative RT-PCR (RT-qPCR) test for severe acute respiratory syndrome coronavirus 2 and its dependence on patient demographic characteristics and disease progression is key in designing epidemiologic strategies. Analyzing 843,917 test results of 521,696 patients, a "positive period" was defined for each patient between diagnosis of coronavirus disease 2019 and the last positive test result. The fraction of positive test results within this period was then used to estimate detection rate. Regression analyses were used to determine associations of detection with time of sampling after diagnosis, patient demographic characteristics, and viral RNA copy number based on RT-qPCR cycle threshold values of the next positive test result. The overall detection rate in tests performed within 14 days after diagnosis was 83.1%. This rate was higher at days 0 to 5 after diagnosis (89.3%). Furthermore, detection rate was strongly associated with age and sex. Finally, the detection rate with the Allplex 2019-nCoV RT-qPCR kit was associated, at the single-patient level, with viral RNA copy number (P < 10). These results show that the reliability of the test result is reduced in later days as well as for women and younger patients, in whom the viral loads are typically lower.
量化广泛使用的实时逆转录聚合酶链反应(RT-qPCR)检测严重急性呼吸综合征冠状病毒 2 的检测率及其对患者人口统计学特征和疾病进展的依赖性,是设计流行病学策略的关键。通过分析 521696 名患者的 843917 次检测结果,为每位患者定义了从 2019 年冠状病毒病诊断到最后一次阳性检测结果之间的“阳性期”。然后,使用该期间内阳性检测结果的分数来估计检测率。回归分析用于确定检测与诊断后采样时间、患者人口统计学特征和基于下一次阳性检测结果的 RT-qPCR 循环阈值的病毒 RNA 拷贝数之间的关联。在诊断后 14 天内进行的检测中,总体检测率为 83.1%。在诊断后 0 至 5 天内,该比率更高(89.3%)。此外,检测率与年龄和性别密切相关。最后,在单个患者水平上,Allplex 2019-nCoV RT-qPCR 试剂盒的检测率与病毒 RNA 拷贝数相关(P < 10)。这些结果表明,随着时间的推移,检测结果的可靠性会降低,对于女性和年轻患者而言,其病毒载量通常较低,因此可靠性也会降低。