自建检测系统测定血清总蛋白精密度性能的评价

Precision evaluation of serum total protein measure using self-developed detecting system

目的评价本科室自建检测系统测定血清总蛋白(TP)的批内精密度、总精密度,熟练掌握临床和实验室标准化协会(CLSI)EP5-A2文件的临床应用。方法配制3个浓度水平的试验样本,采用EP5-A2文件方法评价每个浓度水平的批内精密度、总精密度。结果在初步精密度评价试验中,3个浓度水平试验样本的变异系数(CV)均小于批内精密度目标(Mwr)。所有试验数据均未发现离群点。在精密度评价试验中,3个浓度水平试验样本的批内精密度与其对应的Mwr、总精密度与其对应对总精密度目标(MT)差异无统计学意义(P>0.05)。结论本科室自建检测系统测定血清TP的精密度满足临床需求。

Objective To evaluate within-run precision and total precision of serum total protein（TP） measure using self-de- veloped detecting system, and master the clinical applications of EP5-A2 document issued by the Clinical and Laboratory Stan- dards Institute （CLSI）. Methods Three levels of experimental samples were prepared, and then the within-run precision and the total precision at every level were evaluated following the EP5-A2 document. Results In preliminary precision test, the coeffi- cient of variation （CV） at any level was less than the within-run precision goal, and no outlier was found in all experimental data. In the precision evaluation experiment, there was no significant difference between the within-run precision and the within-run precision goal, and the same was true between total precision and the total precision goal （P〉0.05）. Conclusion The precision of serum TP measure using the self-developed detecting system in our department meets the clinical needs.