Bentley P M
European Spallation Source ESS ERIC, Box 176, SE-221 00 Lund, Sweden.
Heliyon. 2021 Apr;7(4):e06905. doi: 10.1016/j.heliyon.2021.e06905. Epub 2021 Apr 28.
The SARS-CoV-2 pandemic has created a demand for large scale testing, as part of the effort to understand and control transmission. It is important to quantify the error rates of test equipment under field conditions, which might differ significantly from those obtained in the laboratory. A literature review on SARS-CoV-2 reverse-transcription polymerase chain reaction (RT-PCR) is used to construct a test confusion matrix. A simple correction method for bulk test results is then demonstrated with examples. The required sensitivity and specificity of a test are explored for societal needs and use cases, before a sequential analysis of common example scenarios is explored. The analysis suggests that many of the people with mild symptoms and positive test results are unlikely to be infected with SARS-CoV-2 in some regions. It is concluded that current and foreseen alternative tests can not be used to "clear" people as being non-infected. Recommendations are given that regional authorities must establish a programme to monitor operational test characteristics before launching large scale testing; and that large scale testing for tracing infection networks in some regions is not viable, but may be possible in a focused way that does not exceed the working capacity of the laboratories staffed by competent experts. RT-PCR tests can not be solely relied upon as the gold standard for SARS-CoV-2 diagnosis at scale, instead clinical assessment supported by a range of expert diagnostic tests should be used.
作为了解和控制新冠病毒传播努力的一部分，新冠疫情引发了大规模检测的需求。在现场条件下对检测设备的错误率进行量化很重要，因为现场条件下的错误率可能与实验室中获得的错误率有显著差异。通过对新冠病毒逆转录聚合酶链反应（RT-PCR）的文献综述来构建一个检测混淆矩阵。然后通过实例展示了一种针对批量检测结果的简单校正方法。在对常见示例场景进行顺序分析之前，先探讨了社会需求和用例对检测所需的敏感性和特异性。分析表明，在某些地区，许多症状轻微且检测结果呈阳性的人不太可能感染新冠病毒。得出的结论是，当前和可预见的替代检测方法不能用于“证明”人们未被感染。建议地区当局在开展大规模检测之前必须建立一个监测检测操作特性的计划；并且在某些地区进行大规模检测以追踪感染网络是不可行的，但以不超过由专业专家配备人员的实验室工作能力的重点方式进行检测可能是可行的。不能仅仅依靠RT-PCR检测作为大规模新冠病毒诊断的金标准，相反，应采用一系列专家诊断检测支持的临床评估。
