不饱和铁结合力试剂盒的方法学评价  

Method evaluation on serum unsaturated transferrin binding capacity assay

作　　者：董振南[1] 高静[1] 贾兴旺[1] 王玲[1] 

机构地区：[1]解放军总医院生化科,北京100853

出　　处：《中华检验医学杂志》2005年第1期102-104,共3页Chinese Journal of Laboratory Medicine

摘　　要：目的　通过对不饱和铁结合力 (UIBC)试剂盒的化学性能测定 ,评价UIBC测定方法的可靠性。方法　用本方法在日立 76 0 0全自动生化分析仪上对精密度、稳定性、线性、抗干扰性等指标进行评价。结果　本方法化学性能的评价表明 ,批内变异系数分别为 1 6 16 %和 1 2 36 % ,批间变异系数分别为 4 4 4 %和 4 0 3%。线性良好r2 (0 9999) ,30℃加速稳定性在 14d以上 ,血红蛋白、胆红素、甘油三酯、Cu2 + 、Zn2 + 、肝素对测定结果无显著影响 (P >0 0 5 ) ,维生素C浓度为 12 5mg/L时对低值血清有轻微干扰 ,对高值血清无显著干扰 ,不同厂家不饱铁结合力试剂相关性 (r =0 994 4 ,n= 198)良好 ,10 0名年龄在 19～ 5 2岁健康献血员标本用本方法进行UIBC测定 ,正常参考值为 2 6 0～ 5 1 0 μmol/L( x± 2s )。 结论　本方法测定结果准确可靠且操作简便 ,直接在自动生化分析仪上使用 ,值得推广。Objective In order to evaluate the reliability of UIBC assay reagent, chemical characters were determined Methods The precision, stability, linearity and the interference response of this method were evaluated at automated analyzer Hitachi 7600 Results The chemical characters evaluation showed that the within run imprecision ( CVs ) of low value serum is 1 616 % and that of high value serum is 1 236 % The between run imprecision ( CVs ) of low value serum is 4 44 % and that of highvalue serum is 4 03 % r 2 (0 999 9) of serum dilution curve for UIBC showed the reagent has good linearity The accelerated stability at 30℃ is more than 14 days The assay has no significant interference by hemoglobin, bilirubin, lipemia, copper, zinc and heparin ( P > 0 05), there had slight interference to low value serum and had no interference to high value serum by 125 mg/L Vitamin C, the correlation of UIBC reagent kit from different manufacturer was excellent( r = 0 994 4, n = 198) UIBC of serum samples from100 health blood donors (19 years old to 52 years old) were determined with UIBC reagent kit, and the reference result is 26 0-51 0 μmol/L( ± 2 s ) Conclusion The UIBC result determined by this method is exact and reliable The UIBC reagent kit is easy to operate and ready for automated analyzer Then UIBC assay is worth to popularize

关 键 词：不饱和 方法学评价 试剂盒 血清 测定结果 献血员 批间变异 方法化 评价表 结论 

分 类 号：R446.1[医药卫生—诊断学]