OBJECTIVE The purpose of this study was to evaluate a newly developed chemiluminescence immunoassay (CLIA) and compare it to passive agglutination (PA) for the diagnosis of pneumonia caused by Mycoplasma pneumoniae in children. METHOD A total of 291 children suspected of M. pneumoniae infections were enrolled. Serum samples were obtained from routine diagnostic requests, and specific antibodies were simultaneously detected by PA and CLIA. Cohen's kappa was used to assess the agreement between the PA and CLIA assays, multivariate logistic regression analysis was used to evaluate risk factors for the discordance between the PA and CLIA assays. RESULTS The positive rate was 62.2% (181/291) for PA and 61.2% (178/291) for CLIA (P = 0.08). The specificity, sensitivity, negative, and positive predictive values of CLIA for M. pneumoniae infection were 80.09%, 86.7%, 78.8%, and 88.2%, respectively, with the PA test considered as the diagnostic standard. The correlation of the CLIA and PA assays was 76.8%, and the Kappa coefficient was 0.80. Significant correlations were found between the PA titers and the results of MP-IgM (R = 0.88, P < .05) and MP-IgG (R = 0.84, P < .05) detected by CLIA. CONCLUSIONS A high degree of consistency was found between the PA and CLIA methods in detecting M. pneumoniae infections. CLIA is a reliable and rapid method and might be a promising alternative assay to PA for the diagnosis of M. pneumoniae infections.

中文翻译：

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新型化学发光免疫测定与被动凝集法在诊断儿童肺炎支原体感染中的比较。

目的本研究的目的是评估一种新开发的化学发光免疫分析法（CLIA），并将其与被动凝集（PA）进行比较，以诊断儿童肺炎支原体引起的肺炎。方法共有291名怀疑是肺炎支原体感染的儿童入组。从常规诊断要求中获取血清样品，并通过PA和CLIA同时检测特异性抗体。Cohen的kappa用于评估PA和CLIA分析之间的一致性，多变量logistic回归分析用于评估PA和CLIA分析之间不一致的风险因素。结果PA的阳性率为62.2％（181/291），CLIA的阳性率为61.2％（178/291）（P = 0.08）。CLIA对M的特异性，敏感性，阴性和阳性预测值。以PA试验为诊断标准，肺炎的感染率分别为80.09％，86.7％，78.8％和88.2％。CLIA和PA分析的相关性为76.8％，卡伯系数为0.80。CLIA检测到PA滴度与MP-IgM（R = 0.88，P <.05）和MP-IgG（R = 0.84，P <.05）结果之间存在显着相关性。结论PA和CLIA方法在检测肺炎支原体感染方面具有高度的一致性。CLIA是一种可靠且快速的方法，对于诊断肺炎支原体感染，可能是PA的有希望的替代方法。CLIA检测到PA滴度与MP-IgM（R = 0.88，P <.05）和MP-IgG（R = 0.84，P <.05）结果之间存在显着相关性。结论PA和CLIA方法在检测肺炎支原体感染方面具有高度的一致性。CLIA是一种可靠且快速的方法，对于诊断肺炎支原体感染，可能是PA的有希望的替代方法。CLIA检测到PA滴度与MP-IgM（R = 0.88，P <.05）和MP-IgG（R = 0.84，P <.05）结果之间存在显着相关性。结论PA和CLIA方法在检测肺炎支原体感染方面具有高度的一致性。CLIA是一种可靠且快速的方法，对于诊断肺炎支原体感染，可能是PA的有希望的替代方法。