Development of a designated comparison method for alkaline phosphatase measurements and its application to evaluating...

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) published the reference measurement procedure (RMP) for ALP measurement in 2011. However, the RMP is of high requirements for laboratories, complicated, time-consuming and high cost of reagents. Many manufacturers do not trace results to the higher procedure. And there is currently no designated comparison method (DCM) for ALP measurement. Thus, the standardization of ALP measurement is hindered. Automatic biochemical analyzers are easy to operate and widely used in clinical laboratories. Therefore, according to the RMP, establishing a DCM based on an automatic biochemical analyzer will be a practical way to establish traceability to the accuracy base and promote the standardization of ALP measurement. On the basis of conforming to the RMP recommended by IFCC as far as possible, the DCM was established based on a Thermo Indiko automatic biochemical analyzer. Performances of the method were validated. The DCM repeatability and within laboratory imprecision was <1% and <2.5%, respectively. For evaluation of trueness, the biases were within the equivalent limits. Measurement procedure comparisons and biases estimation were carried out between the DCM, the RMP, and the six routine methods using a panel of 40 individual human serum samples. The comparisons between the DCM and the RMP gave satisfying results. Compared with the DCM, the relative biases of some routine methods failed to meet the bias limit derived from biological variation.