乙型肝炎表面抗原确认试验的临床应用探讨

RESEARCH OF THE CLINICAL USAGE OF CONFIRMATORY TEST FOR HBsAg

目的利用国内研发的HBsAg确认试剂和确认方法对乙型肝炎表面抗原阳性标本进行确认试验。方法HBsAg确认试验方法[1]:以特异性抗-HBs抗体中和样本中的HBsAg并设立加对照液的对照孔,然后按常规的酶联免疫吸附试验(ELISA)方法检测样本中的HBsAg含量(吸光度A表示),按公式求得加抗-HBs孔的抑制率,如抑制率≥50%即表示该样本被确认为HBsAg阳性。结果100例血清样本用研发产品的临床试用确认试剂进行测定,结果全部被确认。结论本文用国内最新研究的确认方法和国内研发的确认试剂对乙型肝炎表面抗原阳性样本进行的临床确认试验结果证实,获得了预期的效果,具有良好的特异性和敏感度。在经过更多的临床病例确认试验和改进之后,该方法和试剂在临床中具有推广应用价值。

Objective To setup a confirmatory test for HBsAg detected by enzyme -linked immunosorbent assay （ELISA） reagent developed in China. Method Add specific anti - HBs reagent into sample and setup the control sample. After incubation, detect HBsAg and calculate the inhibition rate according to the routine ELISA test. The sample will be confirmed as HBsAg positive if the rate is greater than 50%. Result All of 100 HBsAg positive serum samples were confirmed as HBsAg positive. Conclusion The result proves that the new clinical confirmatory test with the new developed reagent has acquired the expect purpose. Both the reagent and the method are of specific difference and sensitivity. They are worthy of expansion to clinical use after much more trials and improvements.