Ahmed Naveed, Kalil Mohammad Nur Amin, Yusof Wardah, Bakar Mimi Azliha Abu, Sjahid Afifah Sjamun, Hassan Rosline, Fauzi Mohd Hashairi, Yean Chan Yean
Department of Medical Microbiology and Parasitology, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian 16150, Malaysia.
Department of Emergency Medicine, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian 16150, Malaysia.
Diagnostics (Basel). 2022 Mar 29;12(4):847. doi: 10.3390/diagnostics12040847.
Accurate diagnosis to limit the spread of SARS-CoV-2 is crucial for the clinical management of this lethal infection. Recently, many low-cost and easy-to-use rapid test kits (RTK) have been developed in many countries for the massive screening of SARS-CoV-2. Thus, evaluating the accuracy and reliability of an RTK is critical. The current study was conducted on 157 individuals to evaluate the performance accuracy of rapid SARS-CoV-2 antigen detection kits using different clinical samples compared with qRT-PCR results. Nasopharyngeal swabs were collected from patients for qRT-PCR and RTK tests, and then buccal and nasal, and nasal swabs were collected for RTK tests separately. The nasal and buccal swabs showed high sensitivity (98%) and specificity (100%) compared with the qRT-PCR results. Meanwhile, for nasal, the sensitivity was 96% with 98% specificity, and nasopharyngeal swabs showed 98% sensitivity and 94% specificity. Fisher’s exact test revealed statistical significance (p < 0.05) between nasopharyngeal, nasal and buccal, and nasal swabs compared with qRT-PCR results. The study concludes that different clinical samples used for the rapid diagnosis of SARS-CoV-2 showed high sensitivities and specificities compared with qRT-PCR. The RTKs using nasal and buccal, nasopharyngeal, and nasal swabs are valuable tools for the early detection of SARS-CoV-2, especially when molecular detections are available with limited access and a high infectivity rate, when the timely detection of virus cases is urgently needed. These types of clinical samples are effective to be used by RTKs for surveillance among community and healthcare workers.
准确诊断以限制新冠病毒的传播对于这种致命感染的临床管理至关重要。最近，许多国家开发了许多低成本且易于使用的快速检测试剂盒（RTK）用于大规模筛查新冠病毒。因此，评估RTK的准确性和可靠性至关重要。本研究对157名个体进行，以评估与定量逆转录聚合酶链反应（qRT-PCR）结果相比，使用不同临床样本的快速新冠病毒抗原检测试剂盒的性能准确性。从患者采集鼻咽拭子进行qRT-PCR和RTK检测，然后分别采集口腔和鼻腔拭子以及鼻拭子进行RTK检测。与qRT-PCR结果相比，口腔和鼻拭子显示出高灵敏度（98%）和特异性（100%）。同时，对于鼻拭子，灵敏度为96%，特异性为98%，鼻咽拭子显示灵敏度为98%，特异性为94%。费舍尔精确检验显示，与qRT-PCR结果相比，鼻咽、口腔和鼻拭子以及鼻拭子之间具有统计学显著性（p < 0.05）。该研究得出结论，与qRT-PCR相比，用于快速诊断新冠病毒的不同临床样本显示出高灵敏度和特异性。使用口腔和鼻拭子、鼻咽拭子和鼻拭子的RTK是早期检测新冠病毒的有价值工具，特别是在分子检测获取有限且感染率高、急需及时检测病毒病例的情况下。这些类型的临床样本可有效地被RTK用于社区和医护人员的监测。
