Allahverdiyeva Aytaj, Mese Sevim, Senkal Naci, Medetalibeyoglu Alpay, Onel Mustafa, Uysal Hayriye Kirkoyun, Alaskarov Elvin, Agacfidan Ali
Department of Medical Microbiology and İmmunology, Azerbaijan Faculty of Medicine, Baku, Azerbaijan.
Institute of Health Sciences, İstanbul University, İstanbul, Turkey.
Medicine (Baltimore). 2025 Jul 25;104(30):e43581. doi: 10.1097/MD.0000000000043581.
This study aimed to investigate prolonged severe acute respiratory syndrome coronavirus-2 polymerase chain reaction (PCR) positivity in hospitalized COVID-19 patients and evaluate the diagnostic performance of rapid antigen tests (RAgT) compared to real-time reverse transcription-PCR (RT-PCR). A prospective single-center study included 82 patients with prolonged PCR positivity (≥28 days). Serial RT-PCR and RAgT were performed at days 7 to 10, 14 to 20, and 28 to 30 post-diagnosis. Clinical data, comorbidities, and laboratory parameters (inflammatory markers, hematological, and biochemical profiles) were analyzed. Statistical analyses included sensitivity, specificity, Cohen Kappa, and receiver operating characteristic curve assessment. RAgT demonstrated 100% sensitivity and 74% specificity relative to RT-PCR, with strong agreement (Cohen κ = 0.803, P* < .001). Inflammatory markers were elevated: C-reactive protein (median 3.55 mg/L), ferritin (510 µg/L), and D-dimer (1400 ng/mL). Comorbidities were present in 62% of patients, primarily hypertension (17%) and diabetes mellitus (15%). Female patients exhibited higher inflammatory markers (C-reactive protein, fibrinogen, and lactate dehydrogenase) and anemia prevalence. Receiver operating characteristic analysis revealed excellent discriminative performance (area under the curve = 0.99). RAgT showed high sensitivity in detecting severe acute respiratory syndrome coronavirus-2 among patients with prolonged PCR positivity, suggesting potential utility in differentiating active infection from residual viral RNA. Persistent PCR positivity may correlate with noninfectious viral shedding, and RAgT could complement RT-PCR in clinical decision-making, particularly in resource-limited settings. Further multicenter studies are needed to validate these findings and assess the impact of viral variants.
本研究旨在调查住院的2019冠状病毒病(COVID-19)患者严重急性呼吸综合征冠状病毒2聚合酶链反应(PCR)持续阳性情况,并评估快速抗原检测(RAgT)与实时逆转录PCR(RT-PCR)相比的诊断性能。一项前瞻性单中心研究纳入了82例PCR持续阳性(≥28天)的患者。在诊断后第7至10天、14至20天以及28至30天进行系列RT-PCR和RAgT检测。分析了临床数据、合并症以及实验室参数(炎症标志物、血液学和生化指标)。统计分析包括敏感性、特异性、Cohen Kappa以及受试者工作特征曲线评估。相对于RT-PCR,RAgT的敏感性为100%,特异性为74%,一致性较强(Cohen κ = 0.803,P* < 0.001)。炎症标志物升高:C反应蛋白(中位数3.55 mg/L)、铁蛋白(510 μg/L)和D-二聚体(1400 ng/mL)。62%的患者存在合并症,主要为高血压(17%)和糖尿病(15%)。女性患者的炎症标志物(C反应蛋白、纤维蛋白原和乳酸脱氢酶)及贫血患病率较高。受试者工作特征分析显示具有出色的鉴别性能(曲线下面积 = 0.99)。RAgT在PCR持续阳性的患者中检测严重急性呼吸综合征冠状病毒2时表现出高敏感性,提示在区分活动性感染与残留病毒RNA方面具有潜在用途。PCR持续阳性可能与非感染性病毒脱落相关,并且RAgT在临床决策中可补充RT-PCR,尤其是在资源有限的环境中。需要进一步开展多中心研究以验证这些发现并评估病毒变异体的影响。