临界定值血清作为ELISA定性检测HBsAg结果判断标准的实验研究

Study of low-level HBsAg detection with the critical value sera by ELISA

目的 :建立一种以临界定值血清为结果判断标准的方法 (定值血清界值法 )。方法 :采用三种厂家的 EL ISA试剂对经多聚酶链反应 (PCR)和 Abbott Axsym System全自动免疫分析仪 (微粒子酶免疫发光法 ,MEIA) ,确证的12 4份低浓度 HBs Ag血清进行检测 ,分别用 cut off界值法和定值血清界值法判断结果 ,并进行评价。 结果 :与cut off界值法比较 ,定值血清界值法能有效地消除 EL ISA试剂效期差异对检测结果的影响 (χ2 =0 .0 0～ 3.2 7,P>0 .0 5 ) ,进一步增强了厂家之间 (χ2 =0 .0 0～ 3.2 0 ,P>0 .0 5 )、实验室之间对低浓度 HBs Ag血清检测结果的一致性和准确性。 结论 :定值血清值法客观、科学 ,具有较强的实用性和可靠性 ,值得推广应用。

Objectives: To establish a method for critical value sera which is used to detect low level HBsAg sera by Enzyme linked immunosorbent assay (ELISA) Methods: The results of 124 cases for low level HBsAg sera confirmed ty the Polymerase Chain Reaction (PCR) and the Microparticales Enzyme Immunoassay (MEIA) on Abbott Axsym System were detected with three reagent kits by ELISA, and were judged to evaluate by the cut off value and the 1ng/ml of critical value sera respectively (it was judged to be positive when a concentration of HBsAg in sera was higher than the cut off value or the 1ng/ml of critical value sera, and to be negative to the contrary) Results:It can avoid the effect of period of validity to the method for critical value sera (χ 2=0 00～3 27, P >0 05), and improve the consistency and accuracy of results for low level HBsAg sera with various reagent kits(χ 2=0 00～3 20, P >0 05) and various laboratories, as compared with the method for cut off value Conclusions: The method for Critical value sera with good practicability and reliability is objective and scientific, so it is worth applying forward in clinical laboratory