HBsAg胶体金检测试剂进货性能验证的探讨

Exploration on verification of purchasing performance of HBsAg colloidal gold detection reagent

目的通过使用已知水平的乙型肝炎病毒表面抗原(HBsAg)标准物质和HBsAg阳性标本验证HBsAg胶体金试剂(简称乙肝试纸条)性能,并作对比分析,以确定乙肝试纸条进货性能验证的最佳方法。方法选用不同水平的HBsAg标准物质,分别验证不同厂家乙肝试纸条性能,观察5、10、15、30min后试纸条的变化,同时使用酶联免疫吸附试验(ELISA)检测上述标准物质的S/CO值,挑选最合适的HBsAg阳性标本40份验证乙肝试纸条性能。结果用4IU/mL的标准物质验证试纸条性能时,5min后90%试纸条出现反应性结果,15min后全部试纸条出现反应性结果,另外通过倍比稀释方法,得出最低检出限为2IU/mL,不同厂家之间差异无统计学意义(P>0.05);4IU/mL的标准物质通过ELISA得出相应的S/CO在28.00±2.00,而使用S/CO值28.00±2.00的HBsAg阳性标本验证试纸条性能时,试纸条全部出现反应性结果。结论4IU/mL的HBsAg标准物质或ELISA中S/CO在28.00±2.00的HBsAg阳性标本,均能够作为乙肝试纸条进货性能验证的质控品,采用HBsAg标准物质作为阳性质控品,既没有职业暴露风险,又解决了HBsAg阳性标本反复冻融导致抗原活性下降的问题,是乙肝试纸条进货性能验证的最佳选择。

Objective To verify the performance of HBsAg colloidal gold reagent(HB test strip)by using the known level of HBsAg standard material and HBsAg positive sample and to conduct the comparative analysis for determining the optimal method of HB test strip performance verification.Methods The different levels of HBsAg standard material were selected,and the performance of HB test strips produced by different manufacturers was verified.The changes of test strip after 5,10,15,30 min were observed.The S/CO values of the above standard material were detected by using the ELISA method.Forty most suitable HBsAg positive samples were selected to verify the performance of HB test strip.Results In verifying the performance of test strip by 4 IU/mL standard material,90% of the test strips appeared the reactive results after 5 min,and all test strips appeared the reactive results after 15 min,in addition,the lowest detection limit 2 IU/mL was obtained by the doubling dilution method.The difference among different manufacturers had no statistical significance;the corresponding S/CO value from 4 IU/mL standard material obtained by ELISA was 28.00±2.00,but when verifying the performance of test strip by using the HBsAg positive sample with the S/CO value28.00±2.00,the test strips all appeared the reactive results.Conclusion 4 IU/mL HBsAg standard material or the HBsAg positive samples with S/CO value 28.00 ±2.00 all can serve as the quality control material for purchasing performance verification of HB test strip.Adopting the HBsAg standard material as the positive control material neither has the occupational exposure risk,also resolves the problem of antigen activity decrease due to repeated freezing and thawing of HBsAg positive sample,which is the optimal selection of HB test strip purchasing performance verification.