血红蛋白测定室内质控方法的设计

Design of internal quality control procedures in hemoglobin measurement

目的 从临床或医学实用性质量要求的角度 ,设计血红蛋白测定中的质控方法 ,即确定质控规则和质控测定值的个数。方法 设计质控方法的步骤 :( 1 )以“允许总误差”形式规定质量要求 ;( 2 )确定该测定方法稳定操作下的不精密度或标准差 ( s)和不准确度 (偏差 ) ;( 3 )计算试验的临界系统误差和随机误差 ;( 4 )评价候选质控方法的误差检出概率( Ped)和假失控概率 ( Pfr)。结果 将这一设计方法应用于血红蛋白测定 ,结果表明用 1 3s质控规则 ( N=1 )能容易地达到90 %以上的误差检出目标。

Objective Quality control(QC) procedure ( i.e., control rules and numbers of control measurements per run) has been selected for hemoglobin measurement, to see if the clinical or medical usefulness requirements for quality were met. Methods The approach for designing appropriate QC procedures included the following steps: at first defining requirements for quality in the form of the total allowable analytical error for hemoglobin, then determining the imprecision and inaccuracy of hemoglobin measurement procedure, the lastest calculating the critical systematic and random errors for hemoglobin measurement,assessing the probabilities for error detection and false rejection for candidate control procedure. Results In applying this approach to detect hemoglobin, a design objective of 90% detection of systematic errors was met for Hb by use of 1 3s control limits with one detect control measurements per run(N=1). Conclusion The general design approach is applicable in all measurement systems.