全自动生化分析仪检测尿17-酮类固醇的性能评价

The evaluation of detection performance of automatic biochemical analyzer for urinary 17-ketosteroide

目的:分析全自动生化仪检测尿-17酮类固醇(17-KS)的指标及与手工方法的性能差异。方法:选取110例患者,根据病情将其分为高血压组(50例)、嗜铬细胞瘤组(30例)及库欣综合征组(30例);另随机抽取30名健康受试者作为健康对照组,选取30名高血压待确诊患者作为待确诊组。分别评价生化仪法和手工法17-KS检测的正确度、精密度、线性范围和抗干扰等指标,且对5组临床样本检测进行比较。结果:生化仪法检测17-KS的正确度、精密度、线性范围和抗干扰等相关指标优于手工法;手工法和生化仪法检测定值质控品BIO-RAD的相对偏差分别为8.43%和4.23%,生化仪法临床标本检测的异常率略高于手工法。生化法检测嗜铬细胞瘤阳性率高于手工法,其差异有统计学意义(x^2=4.59,P<0.05)。结论:生化仪法17-KS检测比传统的手工法有更好的检测能力,生化仪法及试剂检测可为临床提供准确的检验数据。

Objective:To analyze the indicators that were detected by automatic biochemical analyzer for urinary 17-ketosteroide(17-KS)and the performance difference between it and manual method.Methods:110 patients were selected and divided into hypertension group(50 cases),pheochromocytoma group(30 cases)and Cushing syndrome group(30 cases)according to their condition.30 healthy volunteers were randomly selected as health control group.30 patients who need be further diagnosed were selected and divided in further diagnosis group.Series of indicators included accuracy,precision,linear range and anti-interference of detecting 17-KS between biochemical analyzer method and manual method were evaluated respectively,and the clinical samples of 5 groups were compared.Results:The accuracy,precision,linear range and anti-interference of biochemical analyzer method were better than those of manual method in detecting 17-KS.And the relative deviations of manual method and biochemical method in detecting quality control products of BIO-RAD fixed-value were 8.43%and 4.23%,respectively.And the abnormal rate of biochemical analyzer method for detecting clinical specimen is slightly higher than that of manual method.The positive rate of biochemical analyzer method for detecting pheochromocytoma was significantly higher than that of manual method(x2=4.59,P<0.05).Conclusion:In detecting 17-KS,the biochemical analyzer method has better detection ability than the traditional manual method.And the biochemical analyzer method and reagent detection can provide accurate test data for the clinical work.