TECAN全自动酶免分析系统检测乙型肝炎血清学标志物的特异性评价

目的对TECAN全自动酶免分析系统检测乙型肝炎表面抗原（HBsAg）和乙型肝炎表面抗体（抗-HBs）的特异性进行评价。方法参考美国临床实验室标准化委员会（NCCLS）EP12-A、EP7-A及有关文献,分别通过加样针的携带污染、加样和加酶间隔时间、溶血干扰等试验对仪器的RSP150/8前处理系统和BEPⅢ后处理系统检测HBsAg、抗-HBs的特异性进行评价。结果标本HBsAg〉8 000 S/CO时,加样针仍未出现携带污染,而标本抗-HBs〉1 000 mIU/mL时加样针出现携带污染现象。已加样HBsAg、抗-HBs阴性及弱阳性标本的反应板室温放置30min内加酶以及标本中加入血红蛋白（浓度≤8 g/L）,未出现假阳性结果。结论高浓度的抗-HBs对加样容易产生携带污染。血红蛋白对HBsAg、抗-HBs试验的干扰并不明显。HBsAg、抗-HBs酶标板在室温放置30 min内加酶对检测结果影响不大。

Evaluation of the specificity of determination of serum markers of hepatitis B by TECAN automatic enzyme immunoassay analyzer

Objective To evaluate the specificities of detecting hepatitis B surface antigen (HBsAg) and anti-hepatitis B surface antigen antibody (anti-HBs) by TECAN automatic enzyme-linked immunosorbent assay (ELISA) analyzer. Methods The specificities of detecting HBsAg and anti-HBs by TECAN automatic ELISA analyzer were evaluated through the tests of the carryover of sampling probes, the interval between adding samples and enzyme, and the interference of haemolysis, according to Document EP12-A and EP7-A and other related literature. Results The carryover of sampling probes did not appear for HBsAg at the concentration >8 000 S/CO. However, for the anti-HBs, it began to appear when the concentration arose to 1 000 mIU/mL. For the negative and weak positive HBsAg and anti-HBs samples, adding the enzyme within 30 min in the room temperature or the haemoglobin(the concentration below 8 g/L)in the samples had no interference on the results. Conclusions High concentration anti-HBs is easy to generate carryover phenomenon of the sampling probe. The interference of haemoglobin is not obvious in the detection of HBsAg and anti-HBs. The ELISA microplates of HBsAg and anti-HBs putting in the room temperature before adding enzyme within 30 min show no obvious influence.