改良试剂瓶提高循环酶法总胆汁酸试剂稳定性的性能评价

Performance evaluation of stability of the total bile acid reagent with improved reagent bottles

目的对改良试剂瓶提高总胆汁酸试剂开瓶后稳定性的性能评价。方法在全自动生化分析仪上分别使用普通试剂瓶和改良试剂瓶贮存循环酶法总胆汁酸试剂,观察高、中值混合血清以及试剂空白检测结果的日间变异CV及趋势性变化,并对两种试剂瓶的检测结果进行差异显著性t检验。结果 (1)改良试剂瓶测定结果趋势性变化较普通试剂瓶明显减缓。(2)普通试剂瓶测定值在监测期前后累计偏差分别为中值-20.37%和高值-22.09%;而改良试剂瓶测定值在监测期前后累计偏差分别为中值3.77%和高值-1.16%。(3)普通生化试剂瓶检测结果日间变异CV分别为中值混合血清9.27%和高值混合血清9.32%;长效试剂瓶分别为中值混合血清3.38%和高值混合血清2.03%。(4)改良试剂瓶贮存TBA试剂的空白值下降低幅度较普通试剂瓶明显减慢。(5)两种试剂瓶在监测期内的测定结果经差异显著性配对t检验,差异有统计学意义(t=4.889,P<0.01)。结论改良试剂瓶对于减缓循环酶法总胆汁酸试剂衰变的性能良好,有利于延长试剂效期,且可显著降低测定结果的日间变异。

Objective To evaluate the stability of the total bile acid reagent after opening the improved bottles. Methods We analyzed the total bile acid reagents in automatic biochemistry respectively by using the common reagent bottles and the improved reagent bottles. Observe daytime variation of CV and trend changes of high, medium mixed complex-value serum and reagent blank test results. Then t test was applied. Results （1）The change trend of the improved reagent bottles was significantly slower than that of the common reagent bottles, （2）The total deviations of common reagent bottles before and after monitoring were -20.37 % and -22.09% respectively. Total devi ations of the improved reagent bottles were 3.77 % and -1.16 % respectively, （3）The daytime variations of the corn rnon reagent bottles in complex-value were 9.27 % and 9.32% respectively; the improved reagent bottles were 3.38% and 2.03% respectively; （4）The reagent blank with improved reagent bottles decline significantly slower than corn mon reagent bottles; （5）The measured result of t test of the two kinds reagent bottles in the monitoring period was t=4. 889,P〈0.01 ,the result there was significantly different. Conclusion The impvored reagent bottles have good performance to slow down the decay of total bile acid reagentand, and it′s suitable for extending the period of reagents′ validity. It can significantly reduce daytime variation.