Analytical and Clinical Evaluation of Lana(TM), the Reagent Measuring 1,5-Anhydroglucitol

Park, Ile Kyu; Ahn, You Hern; Park, Yong Soo; Lee, Chang Beom; Baik, Hong Kyu

Abstract

BACKGROUND: There have been many reports that 1,5-Anhydroglucitol (1,5-AG) was a better marker than the hemoglobin A1c (HbA1c) or fructosamine for monitoring the control of glucose in patients with Diabetes Mellitus (DM). However, there was difficulty in performing the tests on the patient's samples in the hospital laboratory because the measurement was possible only with gas chromatog-raphy or high performance chromatography. Recently, a reagent that can measure 1,5-AG on the automatic chemistry analyzer was introduced. We evaluated the analytical and clinical characteris-tics of the reagent.
METHODS
We measured the 1,5-AG with the Lana(TM) (Japan Chemistry Medicine, Tokyo, Japan) on the automatic chemistry analyzer, TBA-30FR (Toshiba, Otawara, Japan). We evaluated the pre-cision, the recovery rate, the lower detection limit, the reference value, and the correlation with other clinical markers for glucose control of the DM patient.
RESULTS
The within-run precisions of abnormal and normal samples were 1.27% and 1.41%. The between-day precisions were 2.34% and 4.56%, respectively. The recovery rate was 100.1% and 100.7% in abnormal and normal samples, respectively. The lower detection limit was 0.05 mg/L. The reference value from the healthy people was from 12.7 to 50.9 mg/L. The correlation coefficients of the 1,5-AG with glucose and HbA1c were -0.45 and -0.63, respectively.
CONCLUSIONS
The newly introduced reagent for 1,5-AG that could be applied with the automatic chemistry analyzer was enough to satisfy the analytical features and it showed better correlation with HbA1c than with the fasting blood glucose. We expect that the Lana(TM) can be used in hospital lab-oratories to monitor the blood glucose control of DM patients and more studies on the clinical value of the 1,5-AG can be done with the convenient reagent such as this.