比较与评价4种同型半胱氨酸生化试剂的性能

Performance comparison and evaluation of four homocysteine biochemical reagents

目的评价4种用于同型半胱氨酸（Hcy）检测的生化试剂（A、B、C、D）在同一全自动生化分析仪器上的性能。方法对4种Hcy生化试剂的重复性进行评估;将A试剂设为对比试剂,其余3种设为实验试剂,进行相关性分析;应用4种生化试剂分别测定3个厂家提供的试剂配套质控品的Hcy值并计算相对偏差。结果 4种Hcy生化试剂测定同份混合血清的变异系数分别为2.57%、6.12%、2.29%、3.78%;B、C、D试剂与A试剂测定的相关系数分别为0.535 5、0.931 9、0.957 7。4种Hcy试剂分别测定厂家提供的配套质控品Hcy值的相对偏差如下,A：-7.84%-13.57%,B：-19.29%-9.47%,C：-13.94%-6.67%,D：7.86%-27.37%。结论 A、C、D试剂均有较好精密度;B试剂与A试剂的相关性较差,C、D试剂与A试剂的相关性较好;A、C试剂具有较好准确性。A试剂的性能指标要优于其他3种试剂。

Objective To evaluate the performance of the four kinds of biochemical reagents（A,B,C,D）for homocysteine（Hcy）determination on the same automatic biochemical analyzer.Methods The repeatability of the four kinds of reagents were assessed;A reagent was set as contrast agents,the other three were set as experimental reagents,and correlation analysis were performed;detected the Hcy concentrations of the four quality control materials provided by the three manufacturers and calculated relative deviation.Results The coefficient of variation of four kinds of Hcy biochemical agents were 2.57%,6.12%,2.29%,3.78%in the detection of the same mixed serum;the correlation coefficient of B,C,D reagents with A reagents were 0.535 5,0.931 9,and0.957 7respectively.Relative deviation value of Hcy concentration determination were as follows,A：-7.84%-13.57%,B：-19.29%-9.47%,C：-13.94%-6.67%,D：7.86%-27.37%.Conclusion A,C,D reagents have good precision;The correlation between B Reagent and A reagent was not good,while between C,D reagent and A reagent were good;C reagent showed good accuracy;A reagent performance is better than the other three agents.