Epstein H D, Nipper H C, Horowitz G L
Department of Pathology, Charles A. Dana Research Institute, Boston, Mass.
Arch Pathol Lab Med. 1990 Apr;114(4):399-402.
Routine calibration of a cholesterol assay system may compromise rather than improve precision. We compared an enzymatic assay on a centrifugal analyzer using a fixed factor with a factor recalculated from the response of standards assayed with each run. Over 36 batch runs, using three quality control materials, we found no statistically significant difference between the two methods in mean value, but in every case the fixed factor values were significantly more precise. With the risk classification system in effect at the time of the study, 32 (9.4%) of 342 patient serum specimens assayed for cholesterol were classified differently based solely on the method of data reduction. Thus, recalibration of our cholesterol assay system contributed to greater imprecision and to discrepancies in classification of patients' risk levels.
胆固醇检测系统的常规校准可能会降低而非提高精密度。我们将离心分析仪上使用固定因子的酶法检测与每次运行时根据标准品响应重新计算的因子进行了比较。在36次批次运行中，使用三种质量控制材料，我们发现两种方法在平均值上没有统计学上的显著差异，但在每种情况下，固定因子值的精密度明显更高。根据研究时有效的风险分类系统，仅基于数据处理方法，342份检测胆固醇的患者血清标本中有32份（9.4%）被分类不同。因此，我们胆固醇检测系统的重新校准导致了更大的不精密度以及患者风险水平分类的差异。
