Annals of Clinical Biochemistry: International Journal of Laboratory Medicine ( IF 2.2 ) Pub Date : 2020-09-22 , DOI: 10.1177/0004563220963847 Yafang Wan 1 , Zhijie Li 1 , Kun Wang 1 , Tian Li 1 , Pu Liao 1
Objectives: The purpose of the current study was to evaluate the analytical performance of seven kits for detecting IgM/IgG antibodies against coronavirus (SARS-CoV-2) by using four chemiluminescence immunoassay systems.
Methods: Fifty patients diagnosed with SARS-CoV-2 infection and 130 controls without coronavirus infection from the General Hospital of Chongqing were enrolled in the current retrospective study. Four chemiluminescence immunoassay systems, including seven IgM/IgG antibody detection kits for SARS-CoV-2 (A_IgM, A_IgG, B_IgM, B_IgG, C_IgM, C_IgG, and D_Ab), were employed to detect antibody concentrations. The chi-square test, the receiver operating characteristic (ROC) curve and Youdenâs index were determined to verify the cutoff value of each detection system.
Results: The repeatability verification results of the A, B, C, and D systems are all qualified. D-Ab performed best (92% sensitivity and 99.23% specificity), and B_IgM performed worse than the other systems. Except for the A_IgM and C_IgG systems, the optimal diagnostic thresholds and cutoff values of the other kits and their recommendations are inconsistent with each other. B_IgM had the worst AUC, and C_IgG had the best diagnostic accuracy. More importantly, the B_IgG system had the highest false positive rate for testing patients with AIDS, tumours and pregnancies. The A_IgM system test showed the highest false positive rates among elderly individuals over 90 years old. COVID-2019 IgM/IgG antibody test systems exhibit performance differences.
Conclusions: The D-Ab serum diagnosis kit is the most reliable detection system for anti-SARS-CoV-2 antibodies, which can be used as an alternative method for nucleic acid testing.
中文翻译:
ANNALS EXPRESS:使用四个化学发光免疫分析系统对COVID-19特异性抗体检测进行性能验证。
目的:本研究的目的是通过使用四个化学发光免疫分析系统评估七种试剂盒的检测性能,以检测针对冠状病毒的IgM / IgG抗体(SARS-CoV-2)。
方法:本研究纳入了重庆市总医院收治的50例SARS-CoV-2感染患者和130例无冠状病毒感染的对照。使用四个化学发光免疫分析系统,包括七个SARS-CoV-2的IgM / IgG抗体检测试剂盒(A_IgM,A_IgG,B_IgM,B_IgG,C_IgM,C_IgG和D_Ab)来检测抗体浓度。确定卡方检验,接收器工作特性(ROC)曲线和Youden指数,以验证每个检测系统的截止值。
结果:A,B,C和D系统的重复性验证结果均合格。D-Ab表现最佳(灵敏度为92%,特异性为99.23%),B_IgM的表现比其他系统差。除A_IgM和C_IgG系统外,其他试剂盒的最佳诊断阈值和临界值及其建议彼此不一致。B_IgM的AUC最差,而C_IgG的诊断准确性最高。更重要的是,B_IgG系统在测试患有AIDS,肿瘤和妊娠的患者时具有最高的假阳性率。A_IgM系统测试显示90岁以上的老年人中假阳性率最高。COVID-2019 IgM / IgG抗体测试系统显示出性能差异。
结论:D-Ab血清诊断试剂盒是抗SARS-CoV-2抗体最可靠的检测系统,可作为核酸检测的替代方法。