Jiménez C V
Laboratori d'Anàlisis Clíniques, Centre d'Assistència Primaria Santa Coloma, Barcelona, Spain.
Ann Biol Clin (Paris). 1994;52(7-8):529-33.
To establish analytical quality standards based on biological variations and to evaluate the usefulness of reference values for rheumatoid factors (RF), analytical and biological variations in samples from 34 volunteers between 23 and 46 years old were estimated at monthly intervals for six months. The samples were processed in duplicate on a Hitachi 717 automatic analyzer using the manufacturer's reagents. The within- and between-subject coefficients of variation associated with RF were 8.5% and 24.5% respectively, and the individuality index was 0.45, indicating the high individuality of this parameter. The analytical standards of quality estimated as coefficients of variation (%) were: imprecision, 4.2% and inaccuracy, 6.5%. The heterogeneity index of the within-subject variances was 0.17, thus not rejecting the homogeneity hypothesis. The RF may be considered useful for monitoring purposes because of their high individuality and relatively small critical difference (25% for alpha = 0.10). However, when RF levels are normal it is difficult to interpret them because of their high between-subject variability.
为基于生物学变异建立分析质量标准，并评估类风湿因子（RF）参考值的实用性，对34名年龄在23至46岁之间的志愿者的样本进行了为期六个月的每月一次的分析和生物学变异估计。样本使用制造商的试剂在日立717自动分析仪上一式两份进行处理。与RF相关的受试者内和受试者间变异系数分别为8.5%和24.5%，个体性指数为0.45，表明该参数的个体性较高。以变异系数（%）估计的质量分析标准为：不精密度4.2%，不准确性6.5%。受试者内方差的异质性指数为0.17，因此未拒绝同质性假设。由于RF具有较高的个体性和相对较小的临界差异（α=0.10时为25%），可认为其对监测目的有用。然而，当RF水平正常时，由于其受试者间变异性较高，很难对其进行解释。
