比较四种常见HBsAg检测方法的性能并评估其在266803例样本中的诊断价值

发布时间：2018-06-09 05:48

  本文选题：HBsAg + 检测方法　； 参考：《福建医科大学》2016年硕士论文

【摘要】：【目的】乙型肝炎病毒(HBV)感染呈世界性流行,我国HBV感染率较高,临床诊断HBV感染的重要血清学指标是乙型肝炎病毒表面抗原(HBs Ag)。虽有一些同一检测原理的不同检测系统之间的性能比较的报道,但是少见不同检测原理检测体系之间的比较研究。本研究采用大样本范围比较不同检测原理的性能差别,有助于明确不同方法的诊断价值,亦可规范实验室检验路径。【方法】收集2015年8月1日至2015年9月30日期间在福建医科大学附属第一医院测定的250例HBs Ag血清标本,分别采用化学发光微粒子免疫分析法(CMIA)、电化学发光免疫分析(ECLIA)、酶联免疫吸附测定(ELISA)及胶体金免疫层析分析(GICA)四种方法进行检测,参照EP12-A2文件及EP15-A2文件评价其不精密度,应用描述性统计和相关分析计算不同检测方法测定结果的精密度、一致性和相关性;统计福建医科大学附属第一医院2009年1月1日至2015年12月31日期间的所有住院、门诊及体检患者共266803例血清标本的HBs Ag浓度;依据性能评价的结果来推算四种检测方法对266803例患者的诊断价值。【结果】我院HBs Ag阳性率为25.16%(67128/266803),阳性标本HBs Ag浓度分布主要集中在130.01~52000 IU/ml区间(占阳性标本总数的71.43%,总样本例数的17.97%);CMIA、ECLIA、ELISA及GICA检测HBs Ag的C50浓度分别为0.064、0.085、0.17和10.00 IU/ml,四种方法的C5~C95区间是ECLIACMIAELISAGICA。定量检测定值浓度为0.5 IU/ml的HBs Ag,CMIA、ECLIA与ELISA的不精密度(以变异系数CV表示)分别为2.34%、1.51%和14.04%;在250例样本中,CMIA与ECLIA一致性较好,差异无统计学意义(P=0.44),ECLIA和ELISA、CMIA和ELISA、GICA与其它三种方法相比,差异均有统计学意义(P0.001),对由CMIA检测得到的HBs Ag高浓度(≥12.50 IU/ml)及阴性结果(0.05 IU/ml)的标本,四种方法检测的一致性高;ECLIA与CMIA定量的结果有很高的相关性(R2=0.978)。仅当HBs Ag浓度8.0 IU/ml时ELISA与CMIA的相关性较好(R2=0.928),进一步延伸浓度上限至40561 IU/m1时,二者的相关性较差(R2=0.099)。四种方法对266803例HBs Ag进行定性评估时,CMIA与ECLIA两种方法的一致性较好,差异无统计学意义,而ECLIA和ELISA、CMIA和ELISA、GICA与其它三种方法的阴阳性符合率较差,P均小于0.05,差异有统计学意义;以CMIA法检测结果为标准,ECLIA、ELISA及GICA的假阴性率分别为0.86%、2.88%和11.68%。【结论】GICA适合用于HBs Ag的阳性初筛,ELISA可用于HBs Ag的定性筛查,CMIA与ECLIA则可用于定量检测,各实验室可依据自身实际情况和患者的实际需要选择合理、经济的检测方法,建立合适的实验室检测路径。
[Abstract]:[objective] Hepatitis B virus (HBV) infection is prevalent in the world, and the infection rate of HBV is relatively high in China. The important serological index for clinical diagnosis of HBV infection is hepatitis B virus surface antigen (HBs). Although there are some reports on the performance comparison between different detection systems with the same detection principle, there are few comparative studies among different detection principles. In this study, a large sample range was used to compare the performance differences of different detection principles, which was helpful to clarify the diagnostic value of different methods. From August 1, 2015 to September 30, 2015, 250 serum samples of HBs Ag were collected from the first affiliated Hospital of Fujian Medical University. Chemiluminescence microparticle immunoassay (CMIA), electrochemiluminescence immunoassay (ECLIAA), enzyme-linked immunosorbent assay (Elisa) and colloidal gold immunochromatographic assay (GICA) were used to detect the imprecision. Descriptive statistics and correlation analysis were used to calculate the accuracy, consistency and correlation of the results of different detection methods. All hospitalizations in the first affiliated Hospital of Fujian Medical University from 1 January 2009 to 31 December 2015 were counted. HBs Ag concentration in 266803 serum samples from outpatients and physical examination patients; Based on the results of performance evaluation, the diagnostic value of four methods for the diagnosis of 266803 patients was estimated. [results] the positive rate of HBs Ag in our hospital was 25.16 / 67128 / 266803, and the distribution of HBs Ag in positive samples was mainly in the interval of 130.01 ~ 52000 IUU / ml (the total number of positive samples). 71.43, the C50 concentration of CMIAECLIA Elisa and gica for HBs Ag detection were 0.064 ~ 0.085 ~ 0.17 and 10.00 / ml, respectively, and the C5 ~ (5) C _ (95) interval of four methods was ECLIACMIAELISAGICA. The inaccuracy (expressed as CV) of HBs AgCMIAECLIA and Elisa were 2.341.51% and 14.040.The consistency of CMIA and ECLIA in 250 samples was better than that of other three methods, and there was no significant difference between CMIA and ELISACMIA were compared with the other three methods in 250 samples with a fixed concentration of 0.5 IUU / ml. The difference was statistically significant (P 0.001). For the samples with high concentration of HBs Ag (鈮，

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