Commutability evaluation of glycated albumin candidate EQA materials.

Abstract

Objectives: In clinical practice, glycated albumin (GA), as a key biomarker reflecting the level of blood glucose control in the short and medium term, has been widely used in the diagnosis and efficacy monitoring of diabetes. However, the consistency of GA results between different detection systems remains one of the current challenges in laboratory medicine. we evaluated the commutability of 10 evaluated samples to identify candidate EQA materials for GA measurement.

Methods: According to the Clinical and Laboratory Standards Institute (CLSI) document EP14-A3 and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) commutability evaluation program, we used the established isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS) method for serum glycated albumin determination as the comparative method, and six different commercial kits used enzyme assay as the evaluating method. A total of 40 clinical sample serums, 9 pregnancy sample serums, and 10 evaluated samples were analyzed.

Results: For the CLSI approach, pooled serum samples (cRM1-3) at medium concentrations (cRM2) are commutable in 5/6 kits. For the IFCC approach, none of samples commutable.

Conclusions: The commutability evaluation results of the two approaches were different, and the cRM2 has commutability in most enzymatic kits. It can be a commutable material for the EQA project.