The establishment of biological reference intervals of nontraditional glycemic markers in a Chinese population.

BACKGROUND

We established the reference intervals for glycated albumin (GA), fructosamine (FA), and 1,5-anhydroglucitol (1,5-AG) in a Chinese healthy population.

METHODS

This study enrolled a total of 458 eligible reference individuals, consisted of 226 men and 232 women, aged from 20~79 years (median age 43 years), who attending routine healthy checks. We stratified the subjects according to gender (males and females) and age (20-39, 40-59, and 60-79 years), and combined statistical methods with Lahti algorithm, as well as appropriate clinical consideration, to judge whether partitioning for data was needed.

RESULTS

Glycated albumin levels between males and females were statistically different (P<.001), but the absolute difference between the upper reference limits was only 0.31%, which was too small to be clinically relevant. GA levels across the three age groups were statistically different (P<.001), and Lahti algorithm suggested partitioning for 20-59 and 60-79 years, which reference intervals were 10.38%-13.89% and 10.23%-14.79%, respectively. 1,5-AG levels in males were significant higher than females (P<.001), and absolute difference was 51 μmol/L (8.5 μg/mL) in mean level. Thus, partitioning for gender was needed. Reference intervals for 1,5-AG were 107-367 μmol/L for males and 79-306 μmol/L for females. The absolute difference of the lower reference limits for FA was only 7 μmol/L between males and females. FA levels across the three age groups were not statistically different (P>.05). The reference interval for FA was 220-298 μmol/L.

CONCLUSION

New reference intervals for nontraditional glycemic markers were established based on a Chinese population.