In the era of COVID-19 outbreak, various efforts are undertaken to develop a quick, easy, inexpensive, and accurate way for diagnosis. Although many commercial diagnostic kits are available, detailed scientific evaluation is lacking, making the public vulnerable to fear of false-positive results. Moreover, current tissue sampling method from respiratory tract requires personal contact of medical staff with a potential asymptomatic SARSCOV- 2 carrier and calls for safe and less invasive sampling method. Here, we have developed a convenient detection protocol for SARS-COV-2 based on a non-invasive saliva self-sampling method by extending our previous studies on development of a laboratory-safe and low-cost detection protocol based on qRT-PCR. We tested and compared various self-sampling methods of self-pharyngeal swab and self-saliva sampling from non-carrier volunteers. We found that the self-saliva sampling procedure gave expected negative results from all of the non-carrier volunteers within 2 hours, indicating cost-effectiveness, speed and reliability of the saliva-based method. For an automated assessment of the sampling quality and degree of positivity for COVID-19, we developed scalable formulae based on a logistic classification model using both cycle threshold and melting temperature from the qRT-PCR results. Our newly developed protocol will allow easy sampling and spatial-separation between patient and experimenter for guaranteed safety. Furthermore, our newly established risk assessment formula can be applied to a large-scale diagnosis in health institutions and agencies around the world.

中文翻译：

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基于唾液采样和带有风险概率评估的qRT-PCR的终极COVID-19检测方案。

在COVID-19爆发的时代，人们进行了各种努力来开发一种快速，简便，廉价且准确的诊断方法。尽管有许多商业诊断工具包，但缺乏详细的科学评估，使公众容易受到假阳性结果的恐惧。此外，当前呼吸道的组织采样方法要求医务人员与潜在的无症状SARSCOV-2携带者进行个人接触，并呼吁使用安全且侵入性小的采样方法。在这里，我们通过扩展我们以前基于qRT-PCR的实验室安全和低成本检测方案的开发研究，开发了一种基于无创唾液自采样方法的SARS-COV-2便捷检测方案。我们测试并比较了非携带者志愿者自咽拭子和自唾液采样的各种自采样方法。我们发现，自唾液采样程序在2小时内给所有非携带者志愿者带来了预期的负面结果，表明基于唾液的方法的成本效益，速度和可靠性。为了自动评估COVID-19的采样质量和阳性程度，我们基于逻辑分类模型，使用qRT-PCR结果的循环阈值和解链温度，开发了可扩展的公式。我们新开发的协议将允许在患者和实验人员之间轻松进行采样和空间分隔，以确保安全。此外，