ABSTRACT
Objective To investigate the interference of hyperlipidemia and hyperbilirubinaemia to HbA1c measurements by ion‐exchange high‐performance liquid chromatography(IE‐HPLC) method .Methods Fresh whole‐blood samples collected with EDTA‐K2 anticoagulant tubes were divided into four groups :control group(HbA1c<6 .2% ) ,diabetes group(HbA1c≥6 .2% ) ,hyperlipi‐demia group(TG 3 -20 mmol/L);hyperbilirubinaemis group (TBIL 21 -549 μmol/L) .HbA1c of these samples were measured with affinity chromatography(AC‐HPLC) and IE‐HPLC respectively .Results When HbA1c≤18 .7% ,r=0 .993 ;95% confidence interval(CI) of HbA1c results by using IE‐HPLC method was -0 .71 -0 .89 ;coefficient of variation was -5 .8% -6 .8% ;P=0 .198 and the difference was not statistically significant .When HbA1c< 16 .3% ,r= 0 .997;95% CI of HbA1c results with IE‐HPLC method is -0 .31-0 .67;coefficient of variation was -5 .8% -4 .3% .P=0 .000 and the difference was statistically signifi‐cant .No interference was detectded with the results ;When HbA1c was 16 .3% -18 .7% ,positive bias was observed with the re‐sults .When TG≤20 .78 mmol/L ,r=0 .995;95% CI of HbA1c results with IE‐HPLC method was -0 .26-0 .50 ;coefficient of var‐iation was -5 .5% -5 .8% .P=0 .000 and the difference was statistically significant .No interference was detectded with the re‐sults;When TBIL≤549 .3 μmol/L ,r=0 .990 ;95% CI of HbA1c results with IE‐HPLC method was -0 .08 -0 .63;coefficient of variation was -14% -4 .1% .P=0 .000 and the difference was statistically significant .When TBIL≤342 .1 μmol/L ,r= 0 .994 ;95% CI of HbA1c results with IE‐HPLC method was -0 .09-0 .50;coefficient of variation was -5 .5% -4 .1% .No interference was detectded with the results .When TBIL was 380 .7-549 .3 μmol/L ,negative bias was observed with the results .Conclusion Our data indicated that HbA1c measurement with IE‐HPLC method could resist the interference of hyperlipidemia;When TBIL≤380 .7 μmol/L and HbA1c<16 .3% ,the results could meet the needs of general clinical detection .Clinical staff should choose more specific HbA1c measurement method according to the patient's condition .
ABSTRACT
Objective To investigate the Influence of beta-thalassemia minor on four different HbA1c detection systems.Methods All 65 blood samples from March 2014 to August 2014 were collected from Zhongshan Hospital of Sun Yat-sen University , and divided to normal control group ( 40 cases ) , no diabetic group(20 cases) and diabetic group (5 cases) combining with beta-thalassemia minor.The fresh mixed whole-blood samples were used for transferring value-assignment in order to improve the comparability of Bio-Rad variant ⅡTurbo, Primus Ultra2 ,Roche Modular PPI to Bio-Rad Variant Ⅱwhich was NGSP Ⅰlaboratory certificated.The whole-blood concentration of HbA 1c were measured by four detection systems . Differences between normal control group and no diabetic group were compared using the Independent Samples T Test.Then Taking the Primus Ultra 2 as comparable system and others as experimental system ,the HbA1c results from no diabetic group and diabetic group were compared by the standardization NGSP Ⅰlaboratory and statistical techniques of consistency test .Results Compared with Variant Ⅱ detection system, after transferring value-assignment, deviations of Variant Ⅱ, Modular PPI and Variant Ⅱ Turbo were -6%to +6%.The HbA1c testing results from normal control group and no diabetic group had no statistical significance (P>0.05).Linear regression analysis demonstrated that the correlation coefficient of Primus Ultra2 with Variant Ⅱ, Modular PPI, VariantⅡTurbo were 0.995, 0.999 and 0.995, respectively (P<0.01).The percentage deviation of the reference system and experimental system was -6.0% to+6.0%.Conclusion There was no obviously significant influence of beta-thalassemia minor on Bio-Rad Variant Ⅱ,Bio-Rad variant ⅡTurbo,Primus Ultra2,Roche Modular PPI detection systems.
ABSTRACT
Objective To explore the relationship between glucose-6-phosphate dehydrogenase deficiency and type 2 diabetes and to provide reference for clinical diagnosis,monitoring and treatment of Type 2 diabetes.Methods Subjects were selected from our hospital,including 173 cases of healthy volunteers assigned to the control group;1 95 cases with type 2 diabetes conforming to the diagnostic criteria of WHO were assigned to the diabetic group.97 cases were diagnosed with glucose-6-phosphate dehydrogenase deficiency in our hospital,of whom 82 cases were assigned to simple glucose-6-phosphate dehydrogenase deficiency group,and 1 7 cases were assigned to the diabetes with glucose-6-phosphate dehydrogenase deficiency group.The correlation of glucose-6-phos-phate dehydrogenase activity and diabetes was measured by each detected value.Results Compared with the control group,the glu-cose-6-phosphate dehydrogenase activity and RBC count in diabetic group were higher(P <0.05).Positive correlations between glu-cose-6-phosphate dehydrogenase activity and RBC count in the two groups were significant(P <0.05).HbA1c and FBG showed a significant positive correlation in the control group,diabetic group and diabeties with glucose-6-phosphate dehydrogenase deficiency group(P <0.05).But there was no significant correlation in the glucose-6-phosphate dehydrogenase deficiency group.The rate of screening for glucose-6-phosphate dehydrogenase deficiency in diabetes group was 3.6%,and the rate in the control group was 1. 1%.When HbAlc≥6.5%,the rate of screening for glucose-6-phosphate dehydrogenase deficiency in the diabetes group was signifi-cantly higher than that in the control group (χ2 =4.239,P =0.039).Conclusion The level of HbA1c is discordant with that of blood glucose in diabetic patients with glucose-6-phosphate dehydrogenase deficiency group.Diabetes leads to the increasement of the rate of glucose-6-phosphate dehydrogenase deficiency.The glucose-6-phosphate dehydrogenase activity of diabetic patients with non-glucose-6-phosphate dehydrogenase dificiency is higher than that of the normal group.It may be associated with the level of RBC or increase of compensatory.Further more,glucose-6-phosphate dehydrogenase activity may be a good indicator for controlling diabetes,which remains to be further studied.