斯里兰卡用于诊断COVID-19的RT-PCR试剂盒的比较评估

IF 2 Q3 INFECTIOUS DISEASES
Kanchana P. Amarasinghe, A. Murugananthan, P. T. Amalraajan, Mithusha Thavaththurai, Gayathri Ravindran, K. Murugananthan, Shakila K. Gunathilake
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引用次数: 0

摘要

摘要通过实时逆转录聚合酶链式反应(rRT PCR)鉴定基因靶点被认为是诊断严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)感染的金标准。尽管斯里兰卡目前使用了许多商业rRT PCR试剂盒,但尚未对这些试剂盒的分析性能进行充分调查。因此,本研究的目的是评估贾夫纳大学医学院实验室使用的rRT PCR试剂盒(五个试剂盒)的分析性能。将选择用于本研究的五种rRT-PCR试剂盒的性能与作为参考标准的CDC 2019-nCoV RT-PCR诊断小组进行比较。分析了五种不同商业试剂盒的敏感性、特异性、阳性预测值、阴性预测值和Cohenκ系数。本研究使用了分别从有症状个体和无症状健康个体采集的严重急性呼吸系统综合征冠状病毒2型阳性(62)和阴性(32)呼吸道样本。五种商业试剂盒的循环阈值(Ct)值的比较显示了异质性。其中,TaqPathTM试剂盒显示最高的敏感性(98.4%)和试验者间可靠性(0.976)。HBRT-CVID-19试剂盒显示最低的敏感性(91.9%)、特异性(93.7%)和试验间可靠性(0.838)。尽管五个RT-PCR试剂盒显示出不同的敏感性、特异性和Ct值,它们都适用于严重急性呼吸系统综合征冠状病毒2型感染的常规诊断,因为所有值都高于90%。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative Evaluation of RT-PCR Kits Available in Sri Lanka for Diagnosis of COVID-19
Abstract Identification of gene targets by real-time reverse transcriptase PCR (rRT-PCR) is considered as the gold standard for diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Although many commercial rRT-PCR kits are currently used in Sri Lanka, analytical performance of these kits have not been investigated adequately. Therefore, the objective of the present study was to evaluate the analytical performance of rRT-PCR kits used in the laboratory of the Faculty of Medicine, University of Jaffna (five kits). Performance of the five rRT-PCR kits selected for this study was compared with the CDC 2019-Novel Coronavirus (2019-nCoV) RT-PCR Diagnostic Panel as reference standard. The sensitivity, specificity, positive predictive value, negative predictive value and Cohen’s κ coefficient of the five different commercial kits were analyzed. SARS-CoV-2 positive (62) and negative (32) respiratory samples collected respectively from symptomatic individuals and asymptomatic healthy individuals were used in this study. Comparison of the cycle threshold (Ct) values of the five commercial kits revealed heterogeneity. Among them, the TaqPathTM kit showed the highest sensitivity (98.4%) and interrater reliability (0.976). The HBRT-COVID-19 kit showed the lowest sensitivity (91.9%), specificity (93.7%) and interrater reliability (0.838). Although the five RT-PCR kits exhibited varying sensitivity, specificity and Ct values, all of them are suitable for the routine diagnosis of SARS-CoV-2 infections as all values were higher than 90%.
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