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Abstract：
BACKGROUND: There is an increasing disease trend for SARS-COV-2, so need a quick and affordable diagnostic method. It should be highly accurate and save costs compared to other methods. The purpose of this research is to achieve these goals.
METHODS: This study analyzed 342 samples using TaqMan One-Step RT-qPCR and fast One-Step RT-LAMP (Reverse Transcriptase Loop-Mediated Isothermal Amplification). The One-Step LAMP assay was conducted to assess the sensitivity and specificity.
RESULTS: The research reported positive samples using two different methods. In the RT-LAMP method, saliva had 92 positive samples (26.9%) and 250 negative samples (73.09%) and nasopharynx had 94 positive samples (27.4%) and 248 negative samples (72.51%). In the RT-qPCR method, saliva had 86 positive samples (25.1%) and 256 negative samples (74.8%) and nasopharynx had 93 positive samples (27.1%) and 249 negative samples (72.8%). The agreement between the two tests in saliva and nasopharynx samples was 93% and 94% respectively, based on Cohen\'s kappa coefficient (κ) (P < 0.001). The rate of sensitivity in this technique was reported at a dilution of 1 × 101 and 100% specificity.
CONCLUSIONS: Based on the results of the study the One-Step LAMP assay has multiple advantages. These include simplicity, cost-effectiveness, high sensitivity, and specificity. The One-Step LAMP assay shows promise as a diagnostic tool. It can help manage disease outbreaks, ensure prompt treatment, and safeguard public health by providing rapid, easy-to-use testing.
METHODS: This study analyzed 342 samples using TaqMan One-Step RT-qPCR and fast One-Step RT-LAMP (Reverse Transcriptase Loop-Mediated Isothermal Amplification). The One-Step LAMP assay was conducted to assess the sensitivity and specificity.
RESULTS: The research reported positive samples using two different methods. In the RT-LAMP method, saliva had 92 positive samples (26.9%) and 250 negative samples (73.09%) and nasopharynx had 94 positive samples (27.4%) and 248 negative samples (72.51%). In the RT-qPCR method, saliva had 86 positive samples (25.1%) and 256 negative samples (74.8%) and nasopharynx had 93 positive samples (27.1%) and 249 negative samples (72.8%). The agreement between the two tests in saliva and nasopharynx samples was 93% and 94% respectively, based on Cohen\'s kappa coefficient (κ) (P < 0.001). The rate of sensitivity in this technique was reported at a dilution of 1 × 101 and 100% specificity.
CONCLUSIONS: Based on the results of the study the One-Step LAMP assay has multiple advantages. These include simplicity, cost-effectiveness, high sensitivity, and specificity. The One-Step LAMP assay shows promise as a diagnostic tool. It can help manage disease outbreaks, ensure prompt treatment, and safeguard public health by providing rapid, easy-to-use testing.
摘要：
背景：SARS-COV-2有越来越多的疾病趋势，因此需要一种快速且负担得起的诊断方法。与其他方法相比，它应该高度准确并节省成本。本研究的目的是实现这些目标。
方法：本研究使用TaqMan一步RT-qPCR和快速一步RT-LAMP（逆转录酶环介导的等温扩增）分析了342个样品。进行一步LAMP测定以评估灵敏度和特异性。
结果：研究报告了使用两种不同方法的阳性样本。在RT-LAMP方法中，唾液有92个阳性样本（26.9％）和250个阴性样本（73.09％），鼻咽有94个阳性样本（27.4％）和248个阴性样本（72.51％）。在RT-qPCR方法中,唾液有86个阳性样本(25.1%)和256个阴性样本(74.8%),鼻咽有93个阳性样本(27.1%)和249个阴性样本(72.8%).唾液和鼻咽样本中的两项测试的一致性分别为93％和94％，基于科恩的卡帕系数(κ)(P<0.001)。在1×101的稀释度和100％的特异性下报告了该技术的灵敏度。
结论：基于研究结果，一步LAMP测定法具有多种优点。这些包括简单性，成本效益，高灵敏度,和特异性。一步LAMP测定法显示出作为诊断工具的希望。它可以帮助管理疾病爆发，确保及时治疗，并通过提供快速，易于使用的测试。
方法：本研究使用TaqMan一步RT-qPCR和快速一步RT-LAMP（逆转录酶环介导的等温扩增）分析了342个样品。进行一步LAMP测定以评估灵敏度和特异性。
结果：研究报告了使用两种不同方法的阳性样本。在RT-LAMP方法中，唾液有92个阳性样本（26.9％）和250个阴性样本（73.09％），鼻咽有94个阳性样本（27.4％）和248个阴性样本（72.51％）。在RT-qPCR方法中,唾液有86个阳性样本(25.1%)和256个阴性样本(74.8%),鼻咽有93个阳性样本(27.1%)和249个阴性样本(72.8%).唾液和鼻咽样本中的两项测试的一致性分别为93％和94％，基于科恩的卡帕系数(κ)(P<0.001)。在1×101的稀释度和100％的特异性下报告了该技术的灵敏度。
结论：基于研究结果，一步LAMP测定法具有多种优点。这些包括简单性，成本效益，高灵敏度,和特异性。一步LAMP测定法显示出作为诊断工具的希望。它可以帮助管理疾病爆发，确保及时治疗，并通过提供快速，易于使用的测试。
