Sule Waidi Folorunso, Oluwayelu Daniel Oladimeji
Department of Microbiology, Osun State University, Oke-Baale, Osogbo 230212, Nigeria.
Department of Veterinary Microbiology, University of Ibadan, Ibadan 200284, Nigeria.
Pan Afr Med J. 2020 Jul 21;35(Suppl 2):121. doi: 10.11604/pamj.supp.2020.35.24258. eCollection 2020.
COVID-19 impacts global public health, economy, education, tourism/hospitality and sports; rapid and accurate testing of clinical samples dictate effective response. So far, the real-time reverse transcriptase-polymerase chain reaction (RT-qPCR) is the assay of choice for COVID-19 diagnosis considering its rapidity and accuracy in informing on active coronavirus (CoV) infection. Presently, several RT-qPCR protocols with differing sensitivity/specificity are used for performing this assay; some of them are known to have generated debatable test results to constitute challenges worthy of consideration. This review provides a critical assessment of various published works on RT-qPCR assays used for COVID-19 diagnosis with their different indicators of positivity i.e., cycle threshold (Ct) cut-off values. Knowledge of diagnostic tests for COVID-19 is still evolving and, as a prospect, underscores the need for local validation of positive-negative Ct cut-off values when establishing RT-qPCR assays for SARS-CoV-2 detection.
新冠病毒病影响全球公共卫生、经济、教育、旅游/酒店业和体育；对临床样本进行快速准确的检测决定了有效的应对措施。到目前为止，考虑到实时逆转录聚合酶链反应（RT-qPCR）在告知活动性冠状病毒（CoV）感染方面的快速性和准确性，它是新冠病毒病诊断的首选检测方法。目前，有几种具有不同灵敏度/特异性的RT-qPCR方案用于进行该检测；其中一些已知产生了有争议的检测结果，构成了值得考虑的挑战。本综述对用于新冠病毒病诊断的RT-qPCR检测的各种已发表作品进行了批判性评估，这些作品具有不同的阳性指标，即循环阈值（Ct）临界值。对新冠病毒病诊断检测的认识仍在不断发展，展望未来，这凸显了在建立用于检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的RT-qPCR检测时，对阳性和阴性Ct临界值进行本地验证的必要性。
