Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China.
Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.
Expert Rev Mol Diagn. 2021 Jul;21(7):741-747. doi: 10.1080/14737159.2021.1933445. Epub 2021 Jun 4.
Sensitive molecular diagnostic assays are essential for COVID-19 diagnosis. We evaluated the Hecin Scientific SARS-CoV-2 nucleic acid test kit, a dual-target real-time RT-PCR assay targeting the SARS-CoV-2 N and ORF1ab genes.
The Hecin test kit's diagnostic performance in detecting SARS-CoV-2 RNA was compared to the LightMix Modular SARS and Wuhan CoV E-gene kit (TIB Molbiol) and an in-house single-tube nested real-time RT-PCR using 296 clinical specimens, 11 proficiency testing samples, and 30 low-positive deep throat saliva and nasopharyngeal swab (NPS) samples pooled into negative samples in ratios of 1:5, 1:10, and 1:30.
The limit-of-detection of the Hecin test kit was around 500 dC/mL for the N and ORF1ab targets. Sensitivity and specificity of the Hecin test kit were 98.1% (95% CI: 93.4-99.8%) and 100% (98.1-100%), respectively, when measured against the reference method. The Hecin test kit showed fair sensitivity (80%) in low-positive NPS samples pooled in ratios of 1:5 and 1:10. Its performance in pooled samples could be dramatically improved by adjusting the assay Ct cutoff.
The Hecin test kit enables sensitive and specific detection of SARS-CoV-2 in clinical samples and pooled samples.
敏感的分子诊断检测对于 COVID-19 的诊断至关重要。我们评估了 Hecin 科学 SARS-CoV-2 核酸检测试剂盒，这是一种针对 SARS-CoV-2 N 和 ORF1ab 基因的双靶 real-time RT-PCR 检测方法。
将 Hecin 检测试剂盒检测 SARS-CoV-2 RNA 的诊断性能与 LightMix Modular SARS 和武汉 CoV E 基因试剂盒（TIB Molbiol）以及内部单管巢式 real-time RT-PCR 进行比较，共使用了 296 份临床标本、11 份能力验证样本和 30 份低阳性深喉唾液和鼻咽拭子（NPS）样本，这些样本按 1:5、1:10 和 1:30 的比例混合为阴性样本。
Hecin 检测试剂盒的检测限约为 N 和 ORF1ab 靶标 500 dC/mL。与参考方法相比，Hecin 检测试剂盒的灵敏度和特异性分别为 98.1%（95%CI：93.4-99.8%）和 100%（98.1-100%）。当检测低阳性 NPS 样本时，混合样本的灵敏度为 80%（1:5 和 1:10 混合）。通过调整检测的 Ct 截止值，可以显著提高其在混合样本中的性能。
Hecin 检测试剂盒能够在临床样本和混合样本中实现对 SARS-CoV-2 的敏感和特异性检测。
