Context: In the absence of effective treatment or vaccine, the current strategy for the prevention of further transmission of severe acute respiratory syndrome (SARS) CoV-2 (COVID-19) infection is early diagnosis and isolation of cases. The diagnosis of SARS-CoV-2 is done by detecting viral RNA in the nasopharyngeal and throat swabs by real-time polymerase chain reaction (PCR). Many commercial assays are now available for performing the PCR assay. Aims: The aim was to evaluate the performance of the SD Biosensor nCoV real-time detection kit with the real-time PCR kit provided by the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV), Pune (NIV Protocol). Subjects and Methods: A total of 253 pairs of nasopharyngeal-oropharyngeal swabs combined in a single viral transport medium were tested for viral RNA by both the protocols. The sensitivity and specificity of the SD Biosensor were calculated considering the ICMR-NIV kit as the gold standard. Matched pairs of recorded cycle threshold values (Ct values) were compared by Pearson's correlation coefficient. Results: Concordant COVID-19 negative and positive PCR results were reported for 113 and 77 samples, respectively. The SD Biosensor kit additionally detected 62 cases, which were found negative by the NIV protocol. In all discordant positive results by the SD Biosensor kit, the average Ct values were higher than the concordant positive results. A total of forty samples tested positive for E gene by SD Biosensor and having Ct values <25 had 100% concordance with NIV protocol results and 39 samples tested positive for E gene by SD Biosensor having Ct value >32 were all found negative by the NIV protocol. Conclusions: The results highlight the need for careful evaluation of commercial kits before being deployed for screening of COVID-19 infections.


中文翻译：

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两种实时聚合酶链反应检测鼻咽喉拭子检测严重急性呼吸综合征-CoV-2的比较



背景：在缺乏有效治疗或疫苗的情况下，目前预防严重急性呼吸综合征 (SARS) CoV-2 (COVID-19) 感染进一步传播的策略是早期诊断和隔离病例。 SARS-CoV-2 的诊断是通过实时聚合酶链反应 (PCR) 检测鼻咽和咽喉拭子中的病毒 RNA 来完成的。现在有许多商业化验可用于进行 PCR 化验。目的：目的是评估 SD Biosensor nCoV 实时检测试剂盒与印度医学研究委员会国家病毒学研究所 (ICMR-NIV)（浦那）提供的实时 PCR 试剂盒的性能（NIV 协议） 。对象和方法：通过两种方案对合并在单一病毒运输介质中的总共 253 对鼻咽-口咽拭子进行了病毒 RNA 检测。以 ICMR-NIV 试剂盒为金标准计算 SD 生物传感器的灵敏度和特异性。通过皮尔逊相关系数比较记录的周期阈值（Ct 值）的匹配对。结果：分别报告了 113 个样本和 77 个样本的一致的 COVID-19 阴性和阳性 PCR 结果。 SD 生物传感器试剂盒还检测到了 62 例病例，经 NIV 方案发现呈阴性。在 SD 生物传感器试剂盒得出的所有不一致的阳性结果中，平均 Ct 值均高于一致的阳性结果。总共四十个样品通过 SD Biosensor 测试为 E 基因阳性，并且 Ct 值 <25 id=132>32 通过 NIV 方案均呈阴性。 结论：结果强调，在部署商业试剂盒用于筛查 COVID-19 感染之前，需要仔细评估。