Sahu Rupesh, Gupta Amarnath, Rawat Sumit, Das Abhijit
Preventive Medicine, Government Chhindwara Institute of Medical Sciences, Chhindwara, IND.
Preventive Medicine, Government Bundelkhand Medical College, Sagar, IND.
Cureus. 2022 Sep 17;14(9):e29266. doi: 10.7759/cureus.29266. eCollection 2022 Sep.
Background False-negative results derived from RT-PCR tests for diagnosing coronavirus disease (COVID-19) have raised questions about whether to consider them the gold standard for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Using an imperfect gold standard to assess other diagnostic tests would never let the other tests show better diagnostic performance. The best strategy in such cases is to do an agreement analysis, and this study aims to estimate the agreement between real-time reverse transcriptase-polymerase chain reaction (RT-PCR) and rapid antigen test (RAT) for COVID-19 detection. Methods A retrospective study was done using paired data of individuals tested for COVID-19, both by RT-PCR and RAT, obtained from the virology laboratory of Government Bundelkhand Medical College, Sagar, Madhya Pradesh, India. A sample size of 93 was calculated, and the data were abstracted in a data abstraction sheet. Variables included were results of RT-PCR and RAT, age, gender, presence of symptoms, test kit used, and the time duration between sampling for RT-PCR and RAT. Apart from descriptive statistics, keeping in mind the binary outcome of RT-PCR and RAT, Cohen's kappa was calculated for agreement analysis. A p-value of <0.05 was considered significant. Results The data on 100 participants suspected to be infected with COVID-19 (58 male and 42 female) with a mean age of 39.8 (±19.0) years were analysed. The number of discordant pairs was eight. Cohen's kappa showed substantial agreement between RT-PCR and RAT, κ=0.646, (95% CI 0.420 to 0.871), p<0.001. Conclusion Considering the ease of conducting RAT with quick results and substantial agreement with RT-PCR, RAT could be a better choice in detecting SARS-CoV-2 and, hence, COVID-19 disease on a large scale.
背景 用于诊断冠状病毒病(COVID-19)的逆转录聚合酶链反应(RT-PCR)检测出现的假阴性结果引发了关于是否应将其视为检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的金标准的质疑。使用不完善的金标准来评估其他诊断测试永远不会让其他测试表现出更好的诊断性能。在这种情况下,最佳策略是进行一致性分析,本研究旨在估计实时逆转录聚合酶链反应(RT-PCR)和快速抗原检测(RAT)在检测COVID-19方面的一致性。
方法 采用回顾性研究,使用从印度中央邦萨加尔政府本德尔汗德医学院病毒学实验室获得的对COVID-19进行RT-PCR和RAT检测的个体配对数据。计算得出样本量为93,并将数据摘录到数据摘录表中。纳入的变量包括RT-PCR和RAT的结果、年龄、性别、症状表现、使用的检测试剂盒以及RT-PCR和RAT采样之间的时间间隔。除描述性统计外,考虑到RT-PCR和RAT的二元结果,计算Cohen's kappa进行一致性分析。p值<0.05被认为具有统计学意义。
结果 分析了100名疑似感染COVID-19的参与者(58名男性和42名女性)的数据,平均年龄为39.8(±19.0)岁。不一致对的数量为8对。Cohen's kappa显示RT-PCR和RAT之间有高度一致性,κ = 0.646,(95%可信区间0.420至0.871),p < 0.001。
结论 考虑到RAT操作简便、结果快速且与RT-PCR有高度一致性,RAT可能是大规模检测SARS-CoV-2及由此诊断COVID-19疾病的更好选择。