Miller W G, Rhodes D J, Moore C J
Clin Chem. 1982 Nov;28(11):2195-200.
In this procedure, tentative calibration values are assigned to secondary standards by analysis of that material with the routinely used instrument calibrated by use of the former lot of material. Aliquots of serum from patients are then analyzed by the routine method and an appropriate calibration method in which primary standards are used. If the patient-sera results by both methods are the same, the assigned calibration value is assumed to be correct; if not, the calibration value of the secondary-standard material is adjusted to produce agreement in patient-sera results between the two methods. Thus, calibration of the routine method is linked via the calibration method to primary standards as the criterion of accuracy. This approach corrects for matrix interference of serum-based secondary standards. All that is expected for the secondary standard to obtain an accurate result for patient sera is to produce an analytical signal (irrespective of the origin of the signal) that is equivalent to the calibration value. Differences were significant between the secondary-standard calibration value we determined by this procedure and that assigned by the manufacturer for bilirubin, calcium, phosphorus, chloride, CO2, creatinine, glucose, sodium, uric acid, and commonly measured enzymes.
在此程序中,通过使用前一批材料校准的常规仪器分析该材料,为二级标准品赋予暂定校准值。然后,采用常规方法和使用一级标准品的适当校准方法对患者血清等分试样进行分析。如果两种方法得到的患者血清结果相同,则假定所赋予的校准值是正确的;如果不同,则调整二级标准品材料的校准值,以使两种方法的患者血清结果一致。因此,常规方法的校准通过校准方法与作为准确性标准的一级标准品相联系。这种方法校正了基于血清的二级标准品的基质干扰。二级标准品要获得患者血清的准确结果,所期望的只是产生一个与校准值等效的分析信号(无论信号的来源如何)。我们通过此程序确定的二级标准品校准值与制造商指定的胆红素、钙、磷、氯、二氧化碳、肌酐、葡萄糖、钠、尿酸和常用测量酶的校准值之间存在显著差异。