Dinç Harika Öykü, Özdemir Yusuf Emre, Alkan Sena, Güngördü Dalar Zeynep, Gareayaghi Nesrin, Sirekbasan Serhat, Tuyji Tok Yeşim, Kuşkucu Mert Ahmet, Karaali Rıdvan, Özbey Doğukan, Aygün Gökhan, Midilli Kenan, Kocazeybek Bekir
Bezmialem Vakıf University Faculty of Pharmacy, Department of Pharmaceutical Microbiology, İstanbul, Turkey.
Bakırköy Dr. Sadi Konuk Research and Training Hospital, Clinic of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey.
Mikrobiyol Bul. 2021 Apr;55(2):207-222. doi: 10.5578/mb.20219907.
Following the emergence of severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) and using only PCR for diagnosis, antibody tests have been rapidly developed by various commercial companies. There are differences between the sensitivity and specificity of these tests due to the usage of different viral target proteins and antibody subclasses. In order to evaluate the diagnostic use of these tests, we aimed to examine the diagnostic performance, especially sensitivity and specificity, of SARS-CoV-2 IgM, IgA and IgG tests of various companies (Abbott, Roche, Euroimmun, Dia.Pro, Anshlabs, Vircell, UnScience and RedCell), which have different principles (ECLIA/CLIA, EIA, LFA). Current (n= 180) and past (n= 180) COVID-19 patients with clinical and molecular diagnosis of COVID-19 admitted to Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital, Pandemic Polyclinic with suspected COVID-19 infection, were included in our study. The patients admitted within the first 3 weeks after the onset of symptoms were included in the current patient group, and those admitted at the third and after the third week were included in the past patient group. Serum samples (n= 180) obtained from Istanbul Sisli Hamidiye Etfal Training and Research Hospital, Blood Center between April and June 2018 before the COVID-19 pandemic were included in the study as a control group. All the tests included in our study were studied with the recommendations of the manufacturer companies. Between the IgG detection tests with different principles in patients with past COVID-19, the sensitivity and specificity values of the most effective tests were; 86.7%/99.4% (Abbott), 86.1%/98.9% (Dia.Pro), 91.3%/95% (RedCell). Between the IgM detection tests with different principles in current COVID-19 patients, the sensitivity and specificity values were; 67.8%/99.4% (Abbott), 68.9%/98.6% (Vircell), 50%/97.5% (RedCell). Abbott IgM with a kappa coefficient of 0.67 and Vircell IgM + IgA test with a kappa coefficient of 0.65 showed the best fit in patients with current COVID-19 infection. In patients with past COVID-19, Abbott IgG with 0.86 kappa coefficient and Dia.Pro IgG test with 0.85 kappa coefficient showed the best match. Due to the low sensitivity of IgM detection antibody tests, they should not be preferred instead of real-time reverse transcriptase polymerase chain reaction in routine diagnosis. IgG detection tests may be preferred to detect the antibody response and the titers in people who have had COVID-19 for population seroprevalence and especially therapeutic immune plasma production. However, it is thought that the combined use of both ECLIA/CLIA-based and EIA/ELISA-based tests together may be more effective in routine use for SARS-CoV-2 IgG tests.
随着严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的出现，且仅使用聚合酶链反应（PCR）进行诊断，各商业公司迅速开发出了抗体检测方法。由于使用了不同的病毒靶蛋白和抗体亚类，这些检测方法在敏感性和特异性上存在差异。为了评估这些检测方法的诊断用途，我们旨在检测不同公司（雅培、罗氏、欧蒙、迪雅普罗、安赛蜜、维塞尔、非科学和红细胞）的SARS-CoV-2 IgM、IgA和IgG检测方法的诊断性能，尤其是敏感性和特异性，这些检测方法具有不同的原理（电化学发光免疫分析/化学发光免疫分析、酶免疫分析、侧向流动分析法）。本研究纳入了在伊斯坦布尔大学-塞拉哈帕夏医学院医院大流行综合门诊因疑似COVID-19感染而入院的、经临床和分子诊断为COVID-19的现症患者（n=180）和既往患者（n=180）。症状出现后前3周内入院的患者纳入现症患者组，第3周及3周后入院的患者纳入既往患者组。2018年4月至6月COVID-19大流行之前从伊斯坦布尔锡斯利哈米迪耶埃特法尔培训和研究医院血液中心采集的血清样本（n=180）作为对照组纳入研究。我们研究中纳入的所有检测均按照制造商公司的建议进行。在既往COVID-19患者中，不同原理的IgG检测试验中，最有效的检测试验的敏感性和特异性值分别为：86.7%/99.4%（雅培）、86.1%/98.9%（迪雅普罗）、91.3%/95%（红细胞）。在现症COVID-19患者中，不同原理的IgM检测试验的敏感性和特异性值分别为：67.8%/99.4%（雅培）、68.9%/98.6%（维塞尔）、50%/97.5%（红细胞）。kappa系数为0.67的雅培IgM和kappa系数为0.65的维塞尔IgM+IgA检测在现症COVID-19感染患者中拟合度最佳。在既往COVID-19患者中，kappa系数为0.86的雅培IgG和kappa系数为0.85的迪雅普罗IgG检测匹配度最佳。由于IgM检测抗体试验的敏感性较低，在常规诊断中不应优先于实时逆转录聚合酶链反应。IgG检测试验可能更适合用于检测曾感染COVID-19的人群的抗体反应和滴度，以进行人群血清学流行率调查，尤其是用于治疗性免疫血浆的生产。然而，人们认为，基于电化学发光免疫分析/化学发光免疫分析的检测方法和基于酶免疫分析/酶联免疫吸附测定的检测方法联合使用，在SARS-CoV-2 IgG检测常规应用中可能更有效。
Zotero 插件