Hamad Medical Corporation, Doha, Qatar.
Biomedical Research Center, Member of QU Health, Qatar University, Doha, Qatar.
J Med Microbiol. 2022 May;71(5). doi: 10.1099/jmm.0.001499.
The cycle threshold (Ct) value in real-time PCR (RT-PCR) is where a target-specific amplification signal becomes detectable and can infer viral load, risk of transmission and recovery. Use of Ct values in routine practice is uncommon. There is a lack of routine use of Ct values when reporting RT-PCR results in routine practice. To automatically insert Ct values and interpretive comments when reporting SARS-CoV-2 RT-PCR to improve patient management. Routine Ct values across three different RT-PCR platforms were reviewed for concordance at presentation and clearance in patients with COVID-19. An indicative threshold (IT) linked to viral clearance kinetics was defined at Ct30 to categorize Ct values as low and high, reflecting high and low viral loads respectively. The different gene targets of each platform showed high correlation and kappa score agreement (<0.001). Average Ct values were automatically generated with values ≤Ct30 reported as positive and >Ct30 as reactive; interpretive comments were added to all reports. The new reporting algorithm impacted on: physician interpretation of SARS-CoV-2 results; patient management and transfer; staff surveillance; length of stay in quarantine; and redefinition of patient recovery. Incorporation of Ct values into routine practice is possible across different RT-PCR platforms and adds useful information for patient management. The use of an IT with interpretive comments improves clinical interpretation and could be a model for reporting other respiratory infections. Withholding Ct values wastes useful clinical data and should be reviewed by the profession, accreditation bodies and regulators.
实时聚合酶链反应 (RT-PCR) 的循环阈值 (Ct) 值是目标特异性扩增信号变得可检测的地方,并且可以推断病毒载量、传播风险和恢复情况。在常规实践中很少使用 Ct 值。在常规实践中报告 RT-PCR 结果时,缺乏对 Ct 值的常规使用。为了在报告 SARS-CoV-2 RT-PCR 时自动插入 Ct 值和解释性注释,以改善患者管理。对三种不同 RT-PCR 平台的常规 Ct 值进行了回顾,以研究其在 COVID-19 患者出现时和清除时的一致性。在 Ct30 处定义了一个与病毒清除动力学相关的指示性阈值 (IT),将 Ct 值分类为低和高,分别反映高和低病毒载量。每个平台的不同基因靶标显示出高度相关性和kappa 评分一致性(<0.001)。自动生成平均 Ct 值,将≤Ct30 的值报告为阳性,>Ct30 的值报告为反应性;所有报告都添加了解释性注释。新的报告算法对以下方面产生了影响:医生对 SARS-CoV-2 结果的解释;患者管理和转移;员工监测;隔离期的长短;以及重新定义患者康复。在不同的 RT-PCR 平台上将 Ct 值纳入常规实践是可行的,并为患者管理提供了有用的信息。使用 IT 值和解释性注释可以改善临床解释,也可以成为报告其他呼吸道感染的模型。不报告 Ct 值浪费了有用的临床数据,应接受专业人员、认证机构和监管机构的审查。