正确建立医院试剂性能评价方案研究

Study on correct establishment of hospital reagent performance evaluation scheme

目的探讨医院检验科如何正确选择性价比高的生化试剂,以保证临床检验结果的准确性。方法以四川省新成生物科技有限责任公司(新成生物)生产的脂蛋白(a)测定试剂盒(免疫比浊法)为例,检测试剂精密度[要求:批内精密度的变异系数(CV)≤8.00%;批间相对偏差(R)≤10.00%]、分析灵敏度[要求每毫克升(mg/L)脂蛋白(a)的吸光度变化值(△A)≥0.000 5]和准确度[要求:相关系数(r)≥0.975 0;测定平均值应在靶值±20%范围内]。结果新成生物脂蛋白(a)批内精密度CV≤3.45%,批间R≤7.14%;分析灵敏度△A=0.007 4;准确度与知名A厂家相同类型试剂比对相关性良好(r=0.999 8),R=5.88%。结论选择试剂的精密度、分析灵敏度和准确度等测试指标均能满足要求,与某知名A厂家生产的同类产品具有同等质量水平,建立合适可行的生化试剂性能评价方案,有利于医院检验科选择性价比更好的生化试剂,降低成本,提高检测结果的准确性。

Objective To explore how to rightly choose the biochemical reagents with high performance-cost ratio for insuring the accuracy of clinical detection results.Methods The lipoprotein a（Lp a） determination kit（immunoturbidimetry）produced by Sichuan Xincheng Bio-Tech Co.,Ltd.was taken as an example.The precision degree of the test reagent：the within-run precision variable coefficient（CV）≤8.00%;the interassay relative deviation（R）≤10.00%;the analytical sensitivity：△A（change value of absorbance for a mg/L）≥0.000 5,and the accuracy：the correlation coefficient（r）≥0.975 0;the mean detection value： ±20% of the target value.Results For selected test reagent Lp a,the within-run precision CV ≤3.45%,the interassay R ≤ 7.14%,the analytical sensitivity：△A=0.007 4;the accuracy had the good correlation with the same products produced by the wellknown manufacturer A（r=0.999 8,R=5.88%）.Conclusion For the selected reagent,the test indexes of precision,analytical sensitivity and accuracy all meet the requirement,which has the equal quality level of the same products produced by the well-known manufacturer A.Establishing the appropriate and feasible performance evaluation scheme of biochemical reagent is conducive to select better performance-cost ratio biochemical reagent for reducing cost and increasing the accuracy of detection results.