中文摘要：本研究的目的是比较化学发光免疫分析法（CLIA）、酶联免疫吸附法（ELISA）和被动凝集法（PA）在诊断肺炎支原体直接感染方面的效果。试验挑选了280名感染肺炎支原体的患者，收集血样分别进行CLIA、ELISA和PA分析。结果表明：CLIA和ELISA诊断的敏感性高于PA，CLIA与ELISA诊断结果的一致性较高；同时，CLIA在检测IgM 和 IgG方面具有更好的特异性和敏感性，应优先用于肺炎支原体感染的临床诊断。
外文摘要：Objective: This study aimed to compare the performance of chemiluminescence immunoassay (CLIA), enzyme-linked immunosorbent assay (ELISA), and passive agglutination (PA) method in detecting Mycoplasma pneumoniae (MP) infection. Methods: This study enrolled a total of 280 patients who were consecutively seen at the Nanfang Hospital of the Southern Medical University in Guangdong Province, China, between August and December 2016. Serum was collected and examined by CLIA, ELISA, and PA, respectively. Results: There were 180 positive (64.3%) and 100 negative cases (35.7%) by PA, 184 positive (65.7%) and 96 negative cases (34.3%) by CLIA MP- immunoglobulin (Ig) M, 89 positive (31.8%) and 191 negative cases (68.2%) by CLIA MP-IgG, 196 positive (70%) and 84 negative cases (30%) by ELISA MP-IgM, and 114 positive (40.7%) and 166 negative cases (59.3%) by ELISA MP-IgG. Patients were allocated to two groups based on PA results. In PA-negative group (<= 1:40), the positive rates of MP-IgM by CLIA were 22.8% and 51.2% and by ELISA were 33.3% and 53.5%, respectively. In the PA-positive group (1:80 to >= 1:1,280), MP-IgM negative cases showed a decreasing trend: 40%, 18%, 14.3%, 10%, and 6.7% (CLIA), and 43.3%, 8%, 14.3%, 5%, and 6.7% (ELISA). The consistency between CLIA/ELISA MP-IgM, -IgG, and -IgG+MP-IgM was >92% for negative cases and >75% for positive cases, resulting in an overall consistency rate >88%. The kappa coefficients were 0.804, 0.763, and 0.806, respectively. Conclusion: CLIA and ELISA have a higher sensitivity compared with PA. CLIA has a high concordance with ELISA. Moreover, CLIA has a higher specificity and sensitivity for the detection of IgM and IgG and should be used for the clinical diagnosis of MP infection.
外文关键词：chemiluminescence immunoassay； enzyme-linked immunosorbent assay； passive agglutination； mycoplasma pneumonia antibody
作者： Chen, DM； Zhang, YJ； Xu, YJ； Shen, TT； Cheng, GR； Huang, BK； Ruan, XD； Wang, CR
作者单位：南方医科大学
期刊名称：THERAPEUTICS AND CLINICAL RISK MANAGEMENT
期刊影响因子：2.2
出版年份：2018
出版刊次：7
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