Establishment of a reference interval for glycated albumin based on medical check-up data from multiple medical institutions

Abstract

Objectives: Data were collected to establish a reference interval for glycated albumin (GA), as well as to calculate a cutoff value for diagnosing diabetes mellitus and the GA level corresponding to a 75-g oral glucose tolerance test (OGTT) 2 h plasma glucose (2h-PG) level of 200 mg/dL.

Methods: This study involved 1,843 subjects who were undergoing medical check-ups at several medical institutions and whose HbA1c and GA levels had been measured by OGTT.

Results: The GA reference interval that was calculated based on the data obtained from study subjects with normal glucose tolerance was 12.1–17.1%. Using standardized major axis regression, the levels that corresponded to an OGTT 2h-PG level of 11.1 mmol/L were a GA level of 17.5% and an HbA1c level of 47.5 mmol/mol. A receiver-operating characteristic curve analysis was used to calculate the points at which sensitivity and specificity matched as the cutoff values, and the results yielded a GA level of 15.0% (sensitivity 69.3%).

Conclusions: The GA reference interval was calculated to be 12.1–17.1%. We propose a GA level of 17.4% as a cutoff value to diagnose diabetes mellitus and a GA level of 15.0% as a screening cutoff value for diabetes mellitus, taking previous reports into account.

Keywords:

• Diabetes mellitus
• glycated albumin
• HbA1c
• reference interval
• oral glucose tolerance test

Disclosure statement

No potential conflict of interest was reported by the authors.

Ethical statement

The institutional review board of each study center approved the study protocol, and written, informed consent was obtained from all study subjects.