【摘要】 目的为配制精浆生化质控品选择最佳稳定剂并对配制的质控品进行多项性能评价,以期获得结果稳定的精浆生化质控品。方法用三种不同稳定剂配制方案(乙二醇/丙二醇/丙三醇+氯霉素)进行质控品配制,通过精浆生化检测项目(包括中性α-葡萄糖苷酶、柠檬酸、果糖、锌)进行质控品的性能评价,从而选择最佳稳定剂方案。结果均匀性试验中显示,F>2.39(临界值),差异有统计学意义(P<0.05)。SS≤0.3δ准则分析显示,以乙二醇为稳定剂制备的精浆中性α-葡萄糖苷酶质控品SS>0.3δ,存在瓶间差异;其余质控品SS<0.3δ,无瓶间差异。稳定性试验显示,配制质控品t<2.57(临界值),稳定性较好。常规质控监测显示,3种方案的月质控数据均匀分布在±3s范围内,CV值的变化也均在15%以内,其中丙二醇组CV值最小,均小于10%。结论加入乙二醇的质控品精浆中性α-葡萄糖苷酶的水平存在瓶间差异,可能是人员操作不当引起的。加入丙二醇的质控品各项目检测的稳定性最佳,三种质控品性能评价结果均符合临床要求。更多还原

【Abstract】 Objective To select the best stabilizer for the preparation of quality control products for the biochemical tests of seminal plasma and evaluate its homogeneity,stability as well as monitor its routine quality control data to gain stable seminal plasma biochemical quality control products.Methods Three different stabilizer formulation schemes(ethylene glycol/propylene glycol/glycerol+chloramphenicol)were used to prepare quality control products.The performance of quality control products was evaluated by semen biochemical test items(including neutral alpha-glucosidase,citric acid,fructose and zinc),and the best stabilizer scheme was selected.Results The results of ANOVA demonstrated that the F of self-made seminal plasma biochemical quality control products were over critical value 2.39,which were statistically significant(P<0.05).The quality control products of the plasma neutral alpha-glucosidase used glycol as stabilizers,the measurement data was SS>0.3δ,suggesting that there was a between-bottle difference in those quality control products.The other indicators were SS≤0.3δ,showing no between-bottle difference in those items.The results of the t-test analysis were performed between day 8,15,22,29,36 and 1,which had inferior results compared with critical value 2.57,showing that self-made seminal plasma biochemical quality control products have better stability and can maintain for 36 d.The routine quality control monitoring data showed that the measured quality control data of self-made quality control products were uniformly distributed within the range of±3 s,and the change of CVvalue was within 15%.the CVvalue of propylene glycol group was within 10%.Conclusion The test results of neutral alpha-glucosidase in the quality control product plasma added with ethylene glycol is different between bottles,which may be caused by improper operation of personnel.Propylene glycol was added to the quality control products and the stability of each item was the best.The performance evaluation results of the three quality control products met the clinical requirements.更多还原