三种方法四种试剂自动化检测HBV血清标志物结果的对比研究

Comparative Study of Three Methods and Four HBV Kits for Automatic Detection of HBV Markers in Serum

目的评价三种方法四种试剂自动化检测HBV血清标志物结果的差异。方法选择A xSYM、A lise i、SYM-B io自动免疫分析仪分别采用三种方法四种试剂对636例筛选的血清标本进行HB sA g、A n ti-HB s、HB eA g、A n ti-HB e、A n ti-HB c等五项血清标志物检测,并以A xSYM结果为参照,对项目结果不符及项目结果不一致进行分析。结果对636例筛选的血清标本,A lise i KHB、A lise iM urex、SYM-B io与A xSYM比较,其总的项目结果不符率和总的项目结果不一致率分别为12.4%和3.5%,11.1%和2.6%,7.5%和8.6%,各项目结果不符率以A lise iKHB、A lise iM urex的A n ti-HB e和SYM-B io的HB eA g/A n ti-HB c最高,分别为5.0%,5.8%和2.2%;各项目结果不一致率以A lise i KHB、A lise iM urex的A n ti-HB s和SYM-B io的A n ti-HB e最高,分别为2.3%,1.6%和3.2%。结论仪器、方法、试剂不同可导致血清标志物结果的差异,各项目的报告单位、判断标准有待进一步规范,应建立完善的检测血清标志物量值溯源体系。

ObJective To reveal discrepancies of three methods and four HBV kits for detecting HBV markers in serum. Methods 636 serum samples were screened from in-and out-patients detected for five HBV markers including HBsAg,Anti-HBs, HBeAg,Anti-HBe and Anti-HBc by AxSYM with MEIA kits, Alisei with KHB kits,Alisei with Murex kits and SYM-Bio with TR-FIA kits,respectively. The disagreement and the disaccord rates of HBV markers by Alisei with KHB kits,Alisei with Murex kits and SYM-Bio with TR-FIA kits were analysed and compared with that by AxSYM with MEIA kits. Results The total disagreement and the total disaccord rates of HBV markers by Alisei KHB, Alisei Murex and SYM-Bio with AxSYM were 12.4 % and 3.5 %, 11.1% and 2.6 %, 7.5 % and 8. 6 %,repectively. The highest disagreement and the highest disaccord rates of each HBV marker by Alisei KHB,Alisei Murex and SYM-Bio with AxSYM were 5.0% for Anti-HBe and 2. 3% for Anti-HBs,5.8% for Anti-HBe and 1.6% for Anti-HBs,2. 2% for HBeAg/Anti-HBc and 3. 2% for Anti-HBe. Conclusion There are some discrepant results among apparatus,methods and HBV kits for detecting HBV markers in serum. The reported units and judged standards should be standardized furtherly,The traceability system for detecting HBV markers should be established.