PDF(Pubmed)
Abstract：
As the SARS-CoV-2 virus spread throughout the world, millions of positive cases of COVID-19 were registered and, even though there are millions of people already vaccinated against SARS-CoV-2, a large part of the global population remains vulnerable to contracting the virus. Massive nasopharyngeal sample collection in Puerto Rico at the beginning of the pandemic was limited by the scarcity of trained personnel and testing sites. To increase SARS-CoV-2 molecular testing availability, we evaluated the diagnostic accuracy of self-collected nasal, saliva, and urine samples using the TaqPath reverse transcription polymerase chain reaction (RT-PCR) COVID-19 kit to detect SARS-CoV-2. We also created a colorimetric loop-mediated isothermal amplification (LAMP) laboratory developed test (LDT) to detect SARS-CoV-2, as another strategy to increase the availability of molecular testing in community-based laboratories. Automated RNA extraction was performed in the KingFisher Flex instrument, followed by PCR quantification of SARS-CoV-2 on the 7500 Fast Dx RT-PCR using the TaqPath RT-PCR COVID-19 molecular test. Data was interpreted by the COVID-19 Interpretive Software from Applied Biosystems and statistically analyzed with Cohen\'s kappa coefficient (k). Cohen\'s kappa coefficient (k) for paired nasal and saliva samples showed moderate agreement (0.52). Saliva samples exhibited a higher viral load. We also observed 90% concordance between LifeGene-Biomarks\' SARS-CoV-2 Rapid Colorimetric LAMP LDT and the TaqPath RT-PCR COVID-19 test. Our results suggest that self-collected saliva is superior to nasal and urine samples for COVID-19 testing. The results also suggest that the colorimetric LAMP LDT is a rapid alternative to RT-PCR tests for the detection of SARS-CoV-2. This test can be easily implemented in clinics, hospitals, the workplace, and at home; optimizing the surveillance and collection process, which helps mitigate global public health and socioeconomic upheaval caused by airborne pandemics.
摘要：
随着SARS-CoV-2病毒在世界各地的传播，数百万例COVID-19阳性病例被登记，尽管已经有数百万人接种了SARS-CoV-2疫苗，但全球很大一部分人口仍然容易感染该病毒。大流行开始时，波多黎各的大量鼻咽样本收集受到训练有素的人员和测试地点稀缺的限制。为了提高SARS-CoV-2分子检测的可用性，我们评估了自我收集鼻的诊断准确性，唾液,和尿液样本使用TaqPath逆转录聚合酶链反应（RT-PCR）COVID-19试剂盒检测SARS-CoV-2。我们还创建了比色环介导等温扩增（LAMP）实验室开发的测试（LDT）来检测SARS-CoV-2，作为增加社区实验室分子检测可用性的另一种策略。在KingFisherFlex仪器中进行自动化RNA提取，然后使用TaqPathRT-PCRCOVID-19分子测试在7500FastDxRT-PCR上对SARS-CoV-2进行PCR定量。数据由应用生物系统公司的COVID-19解释软件解释，并用科恩的卡帕系数(k)进行统计分析。配对的鼻腔和唾液样本的科恩卡帕系数（k）显示中等一致性（0.52）。唾液样品表现出更高的病毒载量。我们还观察到LifeGene-Biomarks\'SARS-CoV-2快速比色LAMPLDT与TaqPathRT-PCRCOVID-19测试之间90％的一致性。我们的结果表明，在COVID-19检测中，自行收集的唾液优于鼻腔和尿液样本。结果还表明，比色LAMPLDT是检测SARS-CoV-2的RT-PCR测试的快速替代方法。这种测试可以很容易地在诊所实施，医院,工作场所,在家里；优化监控和收集过程，这有助于缓解由空气传播的流行病引起的全球公共卫生和社会经济动荡。
