执诚尿酸检测试剂和优利特尿酸检测试剂对血清尿酸测定结果的比较及偏倚评估

目的通过不同血清尿酸检测试剂对血清尿酸测定结果及偏倚评估进行比较,为血清尿酸测定的标准化和实验室研究提供参考依据。方法以美国临床和实验室标准协会(CLSI)制定的EP9A2文件作为参考标准,利用执诚尿酸检测试剂和优利特尿酸检测试剂在迈瑞-300全自动生化分析仪上对尿酸进行测定,将执诚试剂作为对照组,优利特试剂作为观察组,采用线性回归计算2组试验的检测结果,对2种试剂的临床应用进行判定。结果 2组水平Randox质量控制物的日间变异系数(CV)和总CV均小于日间CV的允许范围;各组间的总体差异具有统计学意义;对照组的尿酸浓度为(393±116)μmol/L,观察组的尿酸浓度为(328±111)μmol/L,2组比较差异具有统计学意义(P<0.05)。经可靠性分析结果表明可靠性系数为0.989,2种试剂的相关系数均>0.975。结论不同试剂在血清尿酸检测中的结果会有一定的偏差,若实验室有2种或2以上的检测试剂,应将不同试剂检测结果进行比较。

The comparison and bias evaluation of serum uric acid detection results with cheng uric acid detection reagent and excellent uric acid

Objective To compare and assess the results and bias of the different serum uric acid detection reagents for providing a reference of standardization and laboratory studies of serum uric acid. Methods As the reference standard of EP9A2 filings established by Clinical and Laboratory Standard Institute （CLSI）, the uric acid （UA） was measured by the executive Cheng UA detection reagents （control group） and Uri test uric acid detection reagents （the observation group） on Mind ray -300 automatic biochemical analyzer, Two sets of tests using a linear regression test results, chnical application of the two agents in clinical determination. Results The levels of quality control material random day and total CV was less than the allowable range of the day; overall difference between the groups was statistically significant; UA concentration in the control group was （393±116） μmol/L, UA concentrations of observation group was （328± 111 ） μol/L, there was statistically significant difference （P〈0.05）. After reliability analysis showed that thereliability coefficient was 0.989, the correlation coefficients were greater than 0.975 of the two agents. Conclusion The results of the different agents in the serum UA detection will have a bias, if the laboratory has two or more detection reagents, reagent test results should be sufficiently different comparison.