化学发光法检测肺炎衣原体抗体的性能评估  

Chemiluminescence detection of Chlamydia pneumoniae antibody performance evaluation

作　　者：周湧 李慧敏 李夏萌 ZHOU Yong;LI Huimin;LI Xiameng(Department of Clinical Laboratory,the Fifth People′s Hospital of Dongguan,Dongguan,Guangdong 454002,China)

机构地区：[1]东莞市第五人民医院检验科,广东东莞454002

出　　处：《国际检验医学杂志》2019年第9期1107-1110,1113,共5页International Journal of Laboratory Medicine

摘　　要：目的探讨化学发光法(CLIA)检测肺炎衣原体(CP)IgG和IgM抗体的性能。方法选择2015年1月至2017年12月在该院呼吸内科确诊的200例肺炎支原体(MP)患者作为观察组,选择同期在该院体检中心接受体检的200例体检健康者作为对照组,分别采用CLIA、酶联免疫吸附测定(ELISA)以及间接免疫荧光(IIF)检测CPIgG和IgM抗体。评估CLIA检测CPIgG和抗体的最低检出限、批内精密度、批间精密度、线性范围、临床符合率以及与ELISA和IIF的一致性。结果 CLIA对于CPIgG抗体的最低检测限为0.01AU/mL;线性范围为3.0～200.0AU/mL;CLSI具有2.15%～6.47%的批内CV和3.17%～6.18%的批间CV。相关性研究显示CLIA与ELISA检测CPIgG和IgM抗体的结果非常一致(Kappa分别为0.900和0.903,均P<0.001),一致百分比分别为85.0%和85.5%。CLIA与IIF法的Kappa=0.905(P<0.001),总体匹配率为80.0%。结论 CLIA检测CP抗体的各项指标符合临床要求,具有操作简便、精密度高等优点,临床上可以替代ELISA和IIF用于CP抗体的检测。Objective To investigate the chemiluminescence immunoassay (CLIA) for the detection of Chlamydia pneumoniae (CP) IgG and IgM antibodies. Methods This study included 200 MP patients diagnosed in the Department of Respiratory Medicine from January 2015 to December 2017 as the observation group,and 200 healthy subjects who were examined at the physical examination center of the hospital during the same period as the control group.The CPIgG and IgM antibodies were detected by CLIA,enzyme linked immunosorbent assay (ELISA) and indirect immunofluorescence technique (IFF),respectively.CLIA was tested for the CPIgG and antibody detection limits,the intra-assay precision,the inter-assay precision,the linear range,the clinical compliance,and the consistency with ELISA and IIF. Results The minimum detection limit of CLIA for CPIgG antibody was 0.01 AU/mL,the linear range was 3.0-200.0 AU/mL,the intra-assay CV was 2.15%-6.47%,and the inter-assay CV was 3.17%-6.18%.Correlation studies showed that the results of CLIA and ELISA for the detection of CPIgG and IgM antibodies were very consistent ( Kappa = 0.900 ,0.903,respectively, P <0.001),and the consistency percentages were 85.0% and 85.5%,respectively. Kappa of CLIA and IIF method was 0.905 ( P <0.001),and the overall matching rate was 80.0%. Conclusion CLIA detection of CP antibodies meets the clinical requirements.It has the advantages of simple operation,high precision,and so on.Clinically,it can replace ELISA and IIF for the detection of CP antibodies.

关 键 词：化学发光法 肺炎衣原体 性能评估 

分 类 号：R446.6[医药卫生—诊断学] R563.1[医药卫生—临床医学]