Clinical Performance of Immunonephelometric Assay and Chemiluminescent Immunoassay for Detection of IgG Subclasses in Chinese

IF 2.6 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY Journal of Clinical Laboratory Analysis Pub Date : 2024-04-02 DOI:10.1002/jcla.25033

Yan Qin, Yuhan Jia, Congcong Liang, Rui Fu, Zhaojun Liang, Yanlin Wang, Min Feng, Chong Gao, Jing Luo

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Abstract

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.

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用于检测中国人 IgG 亚类的免疫浮肿测定法和化学发光免疫测定法的临床表现

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测定（CLIA）检测 IgGSc 和通过 IgGSc 诊断 IgG4-RD 的性能：方法：共招募了 40 名 IgG4-RD 患者、40 名原发性 Sjogren's 综合征（pSS）患者和 40 名健康对照者（HCs）。采集血清样本，用西门子免疫测定法和 CLIA 法同时检测 IgG1、IgG2、IgG3 和 IgG4。结果显示，IgG4-RD 患者的血清 IgG1、IgG2、IgG3 和 IgG4 均高于正常值：结果：IgG4-RD 患者的 IgG4 较高（p 结论：IgG4-RD 患者的 IgG4 较低：CLIA 和西门子免疫测定在检测 IgGSc（尤其是 IgG4）和 IgG1 方面具有良好的一致性和可比诊断价值，可在临床实践中准确识别 IgG4-RD 或 pSS。

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来源期刊

Journal of Clinical Laboratory Analysis 医学-医学实验技术

CiteScore

5.60

自引率

7.40%

发文量

584

审稿时长

6-12 weeks

期刊介绍： Journal of Clinical Laboratory Analysis publishes original articles on newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing. This includes reports from the following fields: immunochemistry and toxicology, hematology and hematopathology, immunopathology, molecular diagnostics, microbiology, genetic testing, immunohematology, and clinical chemistry.