周期阈值对 COVID-19 抗原性能的影响

Rivaldi Febrian, July Kumalawati, Nina Dwi Putri, Linny Luciana, Aria Kekalih
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摘要

COVID-19 抗原是检测 SARS-CoV-2 感染的另一种检验方法。实时逆转录酶聚合酶链反应(rRT-PCR)中的循环阈值(CT)所代表的病毒载量会影响检测的诊断性能。CT 值越高,SARS-CoV-2 抗原的灵敏度越低。本研究的主要目的是确定 rRT-PCR 的最高 CT 值,该值在 COVID-19 抗原检测中仍能产生反应性结果。这项横断面研究于 2020 年 7 月至 2021 年 6 月在 Cipto Mangunkusumo 医生医院的发热门诊进行。研究人员从确诊和疑似确诊为 COVID-19 的患者身上采集了 235 份鼻咽拭子。约 24.7% 的受试者检测结果呈阳性。反应性 COVID-19 抗原结果的最高 CT 值中位数为 28.22(13.33-39.16),而非反应性抗原结果的 CT 值中位数为 34.45(26.08-39.65)。当 CT 值小于 40 时,COVID-19 抗原检测的灵敏度为 63.8%,特异性为 99.4%,阴性预测值 (NPV) 为 89.3%,阳性预测值 (PPV) 为 97.4%。当 CT 值小于 25 时,该检测的灵敏度为 92.3%,特异性为 99.4%,NPV 为 99.4%,PPV 为 92.3%,LR+ 为 163.4,LR- 为 0.1。确定的 CT 值临界点为 29.82,敏感性为 64.9%,特异性为 81%。总之,COVID-19 抗原是筛查有 SARS-CoV-2 感染症状患者的一种有价值的检测方法。了解周期阈值的影响可提高抗原检测的解释能力和可靠性。
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The Impact of Cycle Threshold Value in Influencing the Performance of COVID-19 Antigen
COVID-19 antigen is an alternative test for detecting SARS-CoV-2 infection. Viral load represented by the Cycle Threshold (CT) in the Real-Time Reverse Transcriptase Polymerase Chain Reaction (rRT-PCR) affects the diagnostic performance of the test. Higher CT values result in reduced sensitivity of the SARS-CoV-2 antigen. The main objective of this study was to determine the highest CT value in rRT-PCR that still yielded reactive results in the COVID-19 antigen test. This cross-sectional study was conducted at the Fever Outpatient Clinic in Dr. Cipto Mangunkusumo Hospital from July 2020 to June 2021. Two hundred and thirty-five naso-oropharyngeal swabs were taken from patients with confirmed and suspected COVID-19 diagnoses. About 24.7% of subjects were tested positive. The median highest CT value giving reactive COVID-19 antigen results was 28.22 (13.33-39.16), while the median CT value for non-reactive antigen results was 34.45 (26.08-39.65). At a CT value < 40, the COVID-19 antigen test demonstrated 63.8% sensitivity, 99.4% specificity, 89.3% Negative Predictive Value (NPV), and 97.4% Positive Predictive Value (PPV). At the CT value < 25, the test showed 92.3% sensitivity, 99.4% specificity, 99.4% NPV, 92.3% PPV, 163.4 LR+, and 0.1 LR-. The identified cut-off point for the CT value was 29.82, with a sensitivity of 64.9% and specificity of 81%. In conclusion, COVID-19 antigen is a valuable test for screening patients with symptoms of SARS-CoV-2 infection. Understanding the influence of cycle threshold can enhance the interpretation and reliability of the antigen test.
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