- 作者：Laura Rami ; Montserrat Roura ; Francesca Canalias ; francesca.canalias@uab.cat
- 关键词：ISO ; International Organization for Standardization ; EQA ; external quality assessment ; ALP ; alkaline phosphatase ; AMP ; 2-amino-2-methyl-1-propanol ; DEA ; diethanolamine ; C-RSE ; Committee on Reference Systems for Enzymes ; SEQC ; Sociedad Españ ; ola de B
- 刊名：Clinica Chimica Acta
- 出版年：2012
- 期刊代码：54_00098981
- 类别：med
- 出版时间：16 August, 2012
- 卷：413
- 期：15-16
- 页码：1249-1254
- 文件大小：322 K
Background
The International Standard ISO 18153 establish that one of the requirements to assure the metrological traceability of values for catalytic concentration of enzymes is the commutability of calibrator and control materials used in the reference measurement systems. This approach was applied to verify the commutability of several commercial stabilized materials using the recently published alkaline phosphatase IFCC primary reference procedure and two routine procedures.Methods
ALP catalytic activity was measured in 50 serum samples and 16 commercial materials, including control materials from EQAS programs, using primary reference measurement procedure and two routine measurement procedures with AMP and DEA as buffers. Calibration materials with a value assigned by reference procedure which were proved to be commutable were used to recalculate the serum values obtained by routine procedures.
Results
All commercial materials showed a similar behaviour to the patient specimens when AMP vs IFCC procedures were compared. For DEA vs IFCC comparison only one calibration material and two quality control materials were commutable. Recalculation of serum results with a commutable common calibrator improves the agreement between methods changing the ratio AMP vs IFCC from 1.44 to 1.04 and DEA vs IFCC from 3.02 to 1.05.
Conclusions
The use of a common commutable calibration material allows harmonizing ALP measurements and made traceable patient results to reference procedure.