国产尿酸浓缩试剂用于Olympus AU2700生化分析仪的可行性研究

Evaluation of the application feasibility of homemade uric acid concentrated reagent on Olympus AU2700 biochemical analyzer

目的研究国产尿酸(UA)浓缩试剂在Olympus AU2700生化分析仪上应用的可行性。方法将两种UA浓缩试剂(广州科方医疗器械有限公司、Olympus公司)在Olympus AU2700生化分析仪上校准后同时使用。结果国产UA试剂测定40例临床标本的平均水平显著高于Olympus原装试剂,分别为(319.5±144.7)μmol/L和(312.2±138.7)μmol/L,t=19.95,P<0.01,但两方法测定结果的相关性良好(r=0.9992),国产UA试剂在医学决定水平处的相对偏倚低于CLIA′88允许误差的一半,其检测低值和高值质控血清UA结果的批内、批间和总变异系数(CV)均小于4.25%(1/4的CLIA′88允许误差)。结论国产UA试剂的精密度较高,虽然与Olympus原装UA试剂测定结果有差异,但是两者相关性好、相对偏倚小,具有可比性和一致性,可以用国产试剂替代Olympus原装试剂。

Objective To study the application feasibility of homemade uric acid（UA）concentrated reagent on Olympus AU2700 biochemical analyzer.Methods Two kinds of UA concentrated reagents from Guangzhou Kefang Medical Apparatus Instruments Co.Ltd.and Olympus were applied on Olympus AU2700 biochemical analyzer.They were all liquid reagent and ready for use and used uricase-linked-peroxidase method.According to the profile EP9-A2 described by the NCCLS,the serum concentrations of UA in 40 clinical samples were determined by Olympus original reagent（comparison method）and Kefang（homemade）reagent（test method）,respectively,the results of 40 case samples were collected,Microsoft Office Excel was used for the data analysis,the correlation coefficient and linear equation were calculated,the anticipated bias between the two methods was estimated and the precisions of homemade reagent were also evaluated according to the profile EP5-A described by the NCCLS.Results The mean level of UA in 40 clinical samples determined by homemade reagent was significantly higher than that by Olympus original reagent[（319.5±144.7）μmol/L vs（312.2±138.7）μmol/L,t=19.95,P0.01],but there was a better correlation between the results of UA determined by the two reagents（r=0.999 2）,the relative bias did not exceed the half of allowable error of CLIA＇88 in the different points of medical decision standard and the intra-assay and inter-assay and total coefficient of variation（CV）of homemade reagent were acceptable（4.25%）.Conclusion There is comparability and coherence of serum UA results determined by Olympus original reagent and homemade reagent.The homemade UA reagent has little relative bias and high precision and can be alternative to Olympus original UA reagent.