电化学法确认低浓度乙肝表面抗原的应用研究

Application study on electronchemiluminescence method confirming low level HBV surface antigen

目的 利用罗氏试剂公司研发的乙型肝炎病毒表面抗原（HBsAg）确认试剂对低浓度HBsAg标本进行确认试验，并做初步分析，以期对今后的检测工作有一定的指导价值。方法160例Cutoff指数（C01）在0．9—20．0血清样本来源于本院住院及门诊患者，经罗氏公司e601仪器对其检测并进行中和试验。结果90例COI在0．9～5．0低含量HBsAg血清样本，经确认试验确认阳性率66．7％，阴性率32．2％，不确定率1．1％；受试者工作特征曲线（ROC）分析，当COI在4．2时，特异性可达到100％；乙型肝炎病毒表面抗体（抗一HBs）阳性组与阴性组的弱阳性组确认试验情况阳性率为53．3％和83．3％，两组比较，差异均有统计学意义（P〈0．05）。结论如果条件允许，当HBsAg的COI值0．9～5．0IU／L，尤其当同时抗-HBs阳性时应做确认试验。

Objective To confirm and evaluate the results of low level hepatitis B surface antigen （HBsAg） confirmatory assay by Roche company elecsys system＇ s, and elementary to analyse, to produce direct value with after test work. Methods A total of 160 low level positive HBsAg serum samples the source local to be hospitalized and outpatient service patient which were screened by Roche company electronchearilumineseence and their COI were between 0.9 to 20.0 IU/L were el positive HBsAg serum samples, which were detected by electonchemil retested by neutralization confirmatory test. Results Among 90 low levand 0. 9≤ COI〈 5.0, there were 66.7 % positive rate and 32.2% negative rate andl. 1% uncertain of the confirmatory assay; According to receiver operating characteristic curve, When COI was 4.2, the specificity was 100% ;The positive rate of the confirmatory in the group with positive HBsAb was lower than the group with negative HBsAb were 53.3% and 83.3% positive rate, two groups compare had statistical signifieance（P 〈 0.05）. Conclusions If conditions to permit must be confirmatory assay low level positive HBsAg serum samples when 0.9 ≤COI〈 5.0 especially and HBsAb positive.