CAJ | 학술논문

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。
목적：통과불동혈청뇨산검측시제대혈청뇨산측정결과급편의평고진행비교，위혈청뇨산측정적표준화화실험실연구제공삼고의거。방법이미국림상화실험실표준협회（CLSI）제정적EP9A2문건작위삼고표준，이용집성뇨산검측시제화우리특뇨산검측시제재매서-300전자동생화분석의상대뇨산진행측정，장집성시제작위대조조，우리특시제작위관찰조，채용선성회귀계산2조시험적검측결과，대2충시제적림상응용진행판정。결과2조수평Randox질량공제물적일간변이계수（CV）화총CV균소우일간CV적윤허범위；각조간적총체차이구유통계학의의；대조조적뇨산농도위（393±116）μmol/L，관찰조적뇨산농도위（328±111）μmol/L，2조비교차이구유통계학의의（P<0.05）。경가고성분석결과표명가고성계수위0.989，2충시제적상관계수균>0.975。결론불동시제재혈청뇨산검측중적결과회유일정적편차，약실험실유2충혹2이상적검측시제，응장불동시제검측결과진행비교。
Objective To compare and assess the results and bias of the different serum uric acid detection re-agents 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 mea-sured by the executive Cheng UA detection reagents(control group) and Uri test uric acid detection reagents(the obser-vation group) on Mind ray -300 automatic biochemical analyzer. Two sets of tests using a linear regression test results , clinical 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 signifi-cant; UA concentration in the control group was(393±116)μmol/L, UA concentrations of observation group was(328± 111)μmol/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.