Background:
measurement of Hb A has been recommended for the long-term assessment of glycemic control in diabetic patients. Because different analytical methods measure different glycated hemoglobin species, it has been difficult to compare results
between
laboratories. We compared the concordence of three different methods for determining Hb A and evaluated the diaSTATTM (Bio-Rad, U.S.A.) Hb A autoanalyzer, midget low pressure cation-exchange column chromatography.
Methods:
The performance of DiaSTATTM for measuring Hb A has been evaluated and compared with those of Micro-column test(Bio-Rad, U.S.A.) and IMxR Analyzer (Abbott, U.S.A) based on boronate affinity binding. The results from three methods were
compared
statistically by linear regression analysis.
Results:
Within-run coefficients of variations(CVs) were 4.72%(at Hb a level 5.4%) and 38.4(at Hb A level 9.9%), respectively. Between-run CVs were 4.82%(at Hb A level 5.4%) and 3.02%(at Hb A level 9.9%), respectively. The hb A level from 55 healthy
persons
was measured. The 95% confidence interval ranged form 4.44% to 6.195 with mean value of 5.13%(SD=0.437). The correlation study between diaSTATTM and Micro-column kit by manual resulted in y=0.735x + 1.875(y: Micro-column, x: DiaSTATTM, n=30,
r=0.975).
The regression equation between DiaSTATTM and IMxR was y=0.661x+1.697(y: IMxR, x: DiSTATTM, n=52, r=0.936). The correlation study between IMxR Micro-column kit by manual resulted in y=1.001x-0.233(y: IMxR, x: Micro-column, n=23, r=0.839).
Conclusion:
We concluded that the measurement of Hb A by DiaSTATTM using cation-exchange colum chromatography showed relatively good precision and excellent correlation with other methods, but it showed that increment of Hb A value with an average 18.4%
and
5.3% proportionally higher than IMxR and Micro-column test kit respectively.
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