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

Background To clarify the fundamental characteristics of the Japan Society of Clinical Chemistry reference measurement procedure (JSCC RMP) for glycated albumin (GA), an additional performance study was performed and the correlation between the HPLC method and JSCC RMP was re-evaluated. Methods Repeatability, detection limit, addition recovery, uncertainty of measurement, inter-laboratory comparison, correlation between JSCC RMP and HPLC method were evaluated. Results The coefficient of variation (CV) of the total repeatability for the nine pretreated samples including isotope dilution and hydrolysis, defining that the averages of each of nine MS measurement samples are independent measurement vials, was 1.0%( n = 9). The limit of detection and Quantification of the GA values were 7.4 and 29.5 mmol/mol, respectively. Addition recovery rates were 99.6%–100.4%. The strong correlation (r = 0.999) of measured six serum samples between two laboratories was observed. Certified values and expanded uncertainties for JCCRM 611-2 (M, H, HH) using the JSCC RMP were as follows: JCCRM 611-2M: 232 and 9 mmol/mol, JCCRM611-2H: 359 and 14 mmol/mol, JCCRM611-2HH: 556 and 22 mmol/mol, respectively. The regression equation obtained using the Passing–Bablok method was GA (%) HPLC = 0.0523 × GA (mmol/mol) JSCC RMP + 1.315. Conclusion The basic performance of the JSCC reference procedure for GA measurement was good, and similar results were obtained at other facilities, so it was considered to be robust and suitable as a reference method for GA measurement. Additionally, an equation was established to convert JSCC RMP (mmol/mol) values to the HPLC% values used in clinical practice.