快速抗原检测与逆转录聚合酶链反应在COVID-19高度疑似患者中的比较

Pub Date : 2023-09-01 DOI:10.29271/jcpsp.2023.09.1058
Muhammad Abdur Rahman Afridi, Zafar Ali, Naveed Iqbal
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引用次数: 0

摘要

目的:比较快速抗原试验(RAT)与逆转录聚合酶链反应(RT-PCR)在COVID-19高度疑似患者中的诊断价值,并探讨其诊断参数。研究设计:基于医院的描述性/观察性研究。研究地点和时间:2021年10月至2022年4月,巴基斯坦开伯尔-普赫图赫瓦省白沙瓦医学教学机构/雷丁夫人医院医学系/COVID综合大楼。方法:纳入该医院新冠肺炎综合医院收治的COVID-19高度疑似病例300例,男女不限。回顾性收集患者的数据,包括COVID-19的RAT和RT-PCR。以RT-PCR作为参考检验,并与RAT进行比较。计算RAT诊断COVID-19的诊断统计,并计算其各自的95%置信区间,p≤0.05为显著性。结果:300例患者中,男性137例(45.7%),女性163例(54.3%)。平均年龄56.80±13.72岁。在筛查中,138例(46%)患者检测呈阳性,162例(54%)患者检测呈阴性;而RT-PCR阳性213例(71%),阴性87例(29%)。RAT的敏感性为54.5% (95% CI: 47.52% ~ 61.28%),特异性为74.7% (95% CI: 64.25% ~ 83.42%)。阳性预测值为84.1% (95% CI: 78.26% ~ 88.53%),阴性预测值为40.1% (95% CI: 35.63% ~ 44.79%)。阳性似然比为2.15 (95% CI: 1.47 ~ 3.15)。负似然比为0.61(95% CI: 0.50-0.74)。总体准确率为60.33% (95% CI: 54.55% ~ 65.91%)。结论:与RT-PCR相比,RAT对COVID-19的敏感性和特异性较低,总体准确率为60.33%。关键词:COVID-19,快速抗原检测,敏感性,特异性,RT-PCR
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Comparison of Rapid Antigen Detection Test with Reverse Transcription Polymerase Chain Reaction in Highly Suspected COVID-19 Patients.

Objective: To compare Rapid Antigen Test (RAT) with Reverse Transcription Polymerase Chain Reaction (RT-PCR) in highly suspected COVID-19 patients and to determine its diagnostic parameters.

Study design: Hospital-based, descriptive/observational study. Place and Duration of the Study: Department of Medicine/COVID Complex, Medical Teaching Institution/Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan, from October 2021 to April 2022.

Methodology: A total of 300 highly suspected cases of COVID-19 of either gender admitted in the COVID Complex of the hospital, were included. Data from the patients, including RAT and RT-PCR for COVID-19, were collected retrospectively. RT-PCR was used as the reference test and compared with RAT. Diagnostic statistics of RAT, with their respective 95% confidence intervals were calculated for RAT in diagnosing COVID-19, with significance at p ≤0.05.

Results: Among the 300 patients, 137 (45.7%) were males and 163 (54.3%) were females. The mean age was 56.80 ± 13.72 years. On screening, 138 (46%) patients tested positive and 162 (54%) were negative by RAT; whereas 213 (71%) tested positive and 87 (29%) were negative on RT-PCR. The sensitivity and specificity of RAT were 54.5% (95% CI: 47.52%-61.28%) and 74.7% (95% CI: 64.25%-83.42%), respectively. Positive predicted value was 84.1% (95% CI: 78.26%-88.53%) and negative predictive value was 40.1% (95% CI: 35.63%-44.79%). The positive likelihood ratio was 2.15 (95% CI: 1.47-3.15). The negative likelihood-ratio was 0.61(95% CI: 0.50-0.74). The overall accuracy was 60.33% (95% CI: 54.55%-65.91%).

Conclusion: There was a low sensitivity and specificity of the RAT for COVID-19, with an overall accuracy of 60.33%, compared with RT-PCR.

Key words: COVID-19, Rapid Antigen Test, Sensitivity, Specificity, RT-PCR.

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