间接免疫荧光和酶联免疫吸附试验对嗜肺军团菌的检测效果分析  

Detection of indirect immunofluorescence assay and enzyme-linked immunosorbent assay on legionella pneumophila

作　　者：刘晓丽[1] 张秀芝 蔡军[1] 孙长义[1] 

机构地区：[1]河南省人民医院检验科,河南郑州450003 [2]河南医学高等专科学校,河南郑州451191

出　　处：《现代预防医学》2016年第11期2041-2043,共3页Modern Preventive Medicine

摘　　要：目的评估西班牙VIRCELL公司生产的间接免疫荧光法（indirect immunofluorescence,IIF）和德国欧蒙医学诊断有限公司（EUROIMMUN）的酶联免疫吸附试验（enzyme-linked immunosorbent assay,ELISA）试剂盒对嗜肺军团菌（legionellapneumophila,LP）抗体Ig M检测的等效性。方法采用同步盲对比试验,对360份有呼吸道感染症状患者的血液样本分别用IIF和ELISA进行LP-Ig M检测。结果 （1）IIF与ELISA检测的阳性符合率95.71%[95%置信区间（confidence interval,CI）：88.14%-98.53%],阴性符合率98.56%（95%CI：96.35%-99.44%）,总符合率95.28%（95%CI：92.57%-97.03%）。一致性分析Kappa=0.869,检测结果具有高度一致性。（2）46例交叉干扰样本：腺病毒、流感病毒、呼吸道合胞病毒、Q热立克次体、支原体等阳性样本对两种方法检测LP-IgM结果无影响。（3）33例干扰物质样本：类风湿因子阳性样本、高胆红素样本、高脂样本和溶血样本对两种试剂检测LP-Ig M结果无影响。（4）IIF和ELISA联合应用时,并联试验可以使可疑结果的数量大大减少（IIF：10例;ELISA：13例;并联试验：3例）,检测结果更加明确。结论 VIRCELL公司的IIF和EUROIMMUN的ELISA对LP-Ig M的检测有明显的等效性,由于IIF的高通量性（同时检测9种病原体）,在需要同时检测多种病原体时具有明显优势,ELISA法在需要单独检测嗜肺军团菌时针对性更强,二者联合则可使检测结果更加明确。Objective To evaluate the equivalence between the indirect immunofluorescence assay（IIF） of Spanish VIRCELL company and the enzyme-linked immunosorbent assay（ELISA） of Germany EUROIMMUN company in the detection of legionella pneumophila Ig M（LP-Ig M）.Methods 360 blood samples of the patients with respiratory tract infection symptoms were collected and then detected for LP-Ig M by IIF and ELISA,respectively.Results The positive coincidence rate of IIF and ELISA for the LP-Ig M detection was 95.71%（95% CI：88.14%-98.53%）,with the negative coincidence rate 98.56%（95% CI：96.35%-99.44%） and the total coincidence rate 95.28%（95% CI：92.57%-97.03%）,respectively.With the consistency analysis of Kappa = 0.869,it was obvious that there was the high consistency on the detection results of the two methods.No influence was shown in the 46 cases of cross interference samples on LP-Ig M detection with the two methods,including adenovirus,influenza virus,respiratory synthetic syncytial virus,Q Rickettsia,mycoplasma and other positive samples.And no effect was found on LP-Ig M detection results when the methods applied to 33 cases of samples with interfering substances,including rheumatoid factor positive samples,high fat,high bilirubin samples and hemolytic samples.Combining the two methods,the detection results was clearer.When the parallel test was used,the number of suspicious results reduced greatly（IIF：10 cases,ELISA：13cases,parallel test：3 cases）.Conclusion IIF of VIRCELL company and ELISA of EUROIMMUN company are equivalent in the detection of LP-Ig M.With the high throughput on simultaneous detection of nine pathogens,the IIF has obvious advantages in multiple pathogens detection.While the ELISA method has strong pertinence in the detection of LP.And the combined application of the two methods has more advantages in providing more explicit results.

关 键 词：嗜肺军团菌抗体 间接免疫荧光 酶联免疫吸附试验 一致性分析 并联试验 

分 类 号：R115[医药卫生—公共卫生与预防医学]