本文選題：HBsAg + 檢測方法　； 參考：《福建醫(yī)科大學》2016年碩士論文

【摘要】：【目的】乙型肝炎病毒(HBV)感染呈世界性流行,我國HBV感染率較高,臨床診斷HBV感染的重要血清學指標是乙型肝炎病毒表面抗原(HBs Ag)。雖有一些同一檢測原理的不同檢測系統(tǒng)之間的性能比較的報道,但是少見不同檢測原理檢測體系之間的比較研究。本研究采用大樣本范圍比較不同檢測原理的性能差別,有助于明確不同方法的診斷價值,亦可規(guī)范實驗室檢驗路徑。【方法】收集2015年8月1日至2015年9月30日期間在福建醫(yī)科大學附屬第一醫(yī)院測定的250例HBs Ag血清標本,分別采用化學發(fā)光微粒子免疫分析法(CMIA)、電化學發(fā)光免疫分析(ECLIA)、酶聯(lián)免疫吸附測定(ELISA)及膠體金免疫層析分析(GICA)四種方法進行檢測,參照EP12-A2文件及EP15-A2文件評價其不精密度,應(yīng)用描述性統(tǒng)計和相關(guān)分析計算不同檢測方法測定結(jié)果的精密度、一致性和相關(guān)性;統(tǒng)計福建醫(yī)科大學附屬第一醫(yī)院2009年1月1日至2015年12月31日期間的所有住院、門診及體檢患者共266803例血清標本的HBs Ag濃度;依據(jù)性能評價的結(jié)果來推算四種檢測方法對266803例患者的診斷價值。【結(jié)果】我院HBs Ag陽性率為25.16%(67128/266803),陽性標本HBs Ag濃度分布主要集中在130.01~52000 IU/ml區(qū)間(占陽性標本總數(shù)的71.43%,總樣本例數(shù)的17.97%);CMIA、ECLIA、ELISA及GICA檢測HBs Ag的C50濃度分別為0.064、0.085、0.17和10.00 IU/ml,四種方法的C5~C95區(qū)間是ECLIACMIAELISAGICA。定量檢測定值濃度為0.5 IU/ml的HBs Ag,CMIA、ECLIA與ELISA的不精密度(以變異系數(shù)CV表示)分別為2.34%、1.51%和14.04%;在250例樣本中,CMIA與ECLIA一致性較好,差異無統(tǒng)計學意義(P=0.44),ECLIA和ELISA、CMIA和ELISA、GICA與其它三種方法相比,差異均有統(tǒng)計學意義(P0.001),對由CMIA檢測得到的HBs Ag高濃度(≥12.50 IU/ml)及陰性結(jié)果(0.05 IU/ml)的標本,四種方法檢測的一致性高;ECLIA與CMIA定量的結(jié)果有很高的相關(guān)性(R2=0.978)。僅當HBs Ag濃度8.0 IU/ml時ELISA與CMIA的相關(guān)性較好(R2=0.928),進一步延伸濃度上限至40561 IU/m1時,二者的相關(guān)性較差(R2=0.099)。四種方法對266803例HBs Ag進行定性評估時,CMIA與ECLIA兩種方法的一致性較好,差異無統(tǒng)計學意義,而ECLIA和ELISA、CMIA和ELISA、GICA與其它三種方法的陰陽性符合率較差,P均小于0.05,差異有統(tǒng)計學意義;以CMIA法檢測結(jié)果為標準,ECLIA、ELISA及GICA的假陰性率分別為0.86%、2.88%和11.68%�！窘Y(jié)論】GICA適合用于HBs Ag的陽性初篩,ELISA可用于HBs Ag的定性篩查,CMIA與ECLIA則可用于定量檢測,各實驗室可依據(jù)自身實際情況和患者的實際需要選擇合理、經(jīng)濟的檢測方法,建立合適的實驗室檢測路徑。
[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，

本文編號：1999244