Validation of the Japan Society of Clinical Chemistry (JSCC) recommended reference measurement procedure for glycated albumin determination.

This article focuses on the performance evaluation and validation of the Japan Society of Clinical Chemistry reference measurement procedure (JSCC RMP) for glycated albumin (GA), a biomarker reflecting short-term glycemic control. The JSCC RMP, based on isotope dilution liquid chromatography/mass spectrometry (ID-LC/MS), demonstrated good repeatability (coefficient of variation ~1.0%), low limits of detection (7.4 mmol/mol) and quantification (29.5 mmol/mol), and high addition recovery rates (99.6%–100.4%). A strong correlation (r = 0.999) was observed between measurements from two laboratories, and a conversion equation was established to relate JSCC RMP values (mmol/mol) to the high-performance liquid chromatography (HPLC) method values (%) commonly used in clinical practice. These findings support the JSCC RMP's robustness and suitability as a reference method for GA measurement, although its current use is limited to a single facility in Japan and further international standardization is needed.