从室间质评显露的系统误差剖析试剂盒的性能质量

Analysis of kit quality with systematic error from extralaboratory quality appraisal

以乳酸脱氢酶(LDL→P)为例,剖析了影响试剂盒质量从而导致在室间质评中出现系统偏倚的几个主要因素:1)底物纯度和用量;2)辅酶纯度及杂质的干扰;3)缓冲液生产工艺流程中如忽略缓冲液的pH温度系数,则会偏离最适pH而导致测定结果偏低的系统误差;4)鉴于LD存在同工酶,在确定试剂盒最适配方时既要重点照顾临床样品中常见的同工酶LD1,同时还要兼顾LD5等可能出现的其他同工酶,目的是促进临床酶活性测定结果的准确性。

Using LDH as an example, this paper had analyzed several factors that could affect the quality of reagent kits leading to systematic errors in extralaboratory quality appraisal. The factors included：（ 1 ）The substrate purity and dosage; （2）The coferment purity and interference of impurities ; （3） The systematic error of lower test results caused by ignoring the temperature modulus of pH buffer solution that could deviate from the most suitable pH value ; and（4） Because of the existence of isodynamic enzyme in LDH it is necessary during determination of the most suitable formula of reagent kit to consider the isodynamic enzyme LDH1 in clinical samples while taking into account other possible isodynamic enzymes in LDH 5.