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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两种实时聚合酶链式反应检测鼻咽咽喉联合拭子检测严重急性呼吸综合征冠状病毒 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系统综合症 (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。许多商业化验现在可用于执行 PCR 化验。目的：目的是使用印度医学研究委员会-国家病毒学研究所 (ICMR-NIV)、浦那 (NIV 协议) 提供的实时 PCR 试剂盒评估 SD Biosensor nCoV 实时检测试剂盒的性能. 主题和方法：两种方案共检测了 253 对鼻咽-口咽拭子在单一病毒转运培养基中的病毒 RNA。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匹配的记录周期阈值（Ct 值）对。结果：分别报告了 113 个和 77 个样本的 COVID-19 阴性和阳性 PCR 结果一致。SD Biosensor 试剂盒另外检测到 62 例，NIV 协议发现这些病例为阴性。在 SD Biosensor 试剂盒的所有不一致的阳性结果中，平均 Ct 值高于一致的阳性结果。共有 40 份 SD Biosensor E 基因检测阳性且 Ct 值 <25 的样本与 NIV 协议结果 100% 一致，SD Biosensor 检测 E 基因阳性且 Ct 值 >32 的 39 个样本均被 NIV 发现为阴性协议。结论：结果强调了在用于筛查 COVID-19 感染之前对商业试剂盒进行仔细评估的必要性。