背景:IgG亚类(IgGSc)的检测对于疾病的诊断和管理至关重要,尤其是IgG4相关疾病(IgG4-RD)。本研究旨在评估化学发光免疫分析法(CLIA)检测IgGSc和通过IgGSc诊断IgG4-RD的性能。
方法:共有40名IgG4-RD患者,40患有原发性干燥综合征(PSS),和40名健康对照(HCs)入组。收集血清样品,通过西门子免疫比浊法和CLIA同时检测IgG1,IgG2,IgG3和IgG4。进行相关性分析,并通过受试者工作特征(ROC)曲线分析诊断价值。
结果:IgG4-RD患者的IgG4高于pSS患者(p<0.001),IgG1低于pSS患者(p<0.001),HC。通过Siemens免疫比浊法和CLIA的结果显示,在检测IgG1,IgG2,IgG3和IgG4方面具有很强的相关性(分别为r=0.937,r=0.847,r=0.871,r=0.990,所有p<0.001)。使用两种测定的IgG1、IgG2、IgG3和IgG4的总和与IMMAGE800的总IgG强烈相关(r=0.866,r=0.811,两者分别p<0.001)。为了将IgG4-RD与PSS和HC区分开来,在CLIAIgG4和西门子免疫比浊法IgG4中没有观察到显著差异(z=0.138,p=0.891),这提供了0.951(p<0.001)和0.950(p<0.001)的曲线下面积(AUC),分别。CLIAIgG1和西门子免疫比浊法IgG1在区分pSS与IgG4-RD和HC方面的AUC分别为0.761(p<0.001)和0.765(p<0.001),分别,差异无统计学意义(z=0.228,p=0.820)。
结论:CLIA和Siemens免疫比浊法在检测IgGSc时具有良好的一致性,尤其是IgG4和IgG1,在临床实践中可以准确识别IgG4-RD或pSS。
BACKGROUND: Detection of IgG subclasses (IgGSc) is vital for the diagnosis and management of disease, especially IgG4-related diseases (IgG4-RD). This study aimed to evaluate the performances of the chemiluminescent immunoassay (CLIA) for detecting IgGSc and diagnosing IgG4-RD by IgGSc.
METHODS: A total of 40 individuals with IgG4-RD, 40 with primary Sjogren\'s syndrome (pSS), and 40 healthy controls (HCs) were enrolled. Serum samples were collected for the simultaneous detection of IgG1, IgG2, IgG3, and IgG4 by the Siemens immunonephelometric assay and the CLIA. The correlation analysis was performed, and diagnostic value was analyzed by the receiver operating characteristic (ROC) curve.
RESULTS: Patients with IgG4-RD had higher IgG4 (p < 0.001) and lower IgG1 (p < 0.001) than those with pSS, and HC. The results by the Siemens immunonephelometric assay and the CLIA showed a strong correlation in detecting IgG1, IgG2, IgG3, and IgG4 (r = 0.937, r = 0.847, r = 0.871, r = 0.990, all p < 0.001, respectively). The sum of IgG1, IgG2, IgG3, and IgG4 using two assays strongly correlated with total IgG by the IMMAGE 800 (r = 0.866, r = 0.811, both p < 0.001, respectively). For discriminating IgG4-RD from pSS and HC, no significant differences were observed in CLIA IgG4 and Siemens immunonephelometric assay IgG4 (z = 0.138, p = 0.891), which provided the area under the curves (AUCs) of 0.951 (p < 0.001) and 0.950 (p < 0.001), respectively. The AUCs of CLIA IgG1 and Siemens immunonephelometric assay IgG1 in distinguishing pSS from IgG4-RD and HC were 0.761 (p < 0.001) and 0.765 (p < 0.001), respectively, with no significant differences (z = 0.228, p = 0.820).
CONCLUSIONS: The CLIA and the Siemens immunonephelometric assay appeared to have good consistency with comparable diagnostic value in detecting IgGSc, especially IgG4, and IgG1 that can accurately identify IgG4-RD or pSS in clinical practice.