Application of improved reagent in Bio-Rad variant II HbA1c analyzer

Objective To analyze the application of a new reagent in Bio-Rad variant II HbA1c analyzer. Methods Accuracy,linear analysis of diluted sample,whole blood and diluted samples,and stability of diluted samples of the new reagent,as well as its correlation with the old reagent were evaluated. Results The between-run and within-run accuracy of diluted sample was ≤1.4% and ≤0.93%,respectively.The accuracy of whole blood sample was higher than that of diluted sample.The linear theoretical value of diluted sample was well correlated with its measured value（r=0.998 5,P＜0.01）.No statistical difference was found in diluted and whole blood samples（P＞0.05）.However,a statistical difference was observed in diluted and whole blood samples of the old reagent（P＜0.01）.The value of diluted sample was higher than that of whole blood sample.The diluted samples kept at room temperature for 10h were stable,with no difference with those kept at room temperature for 0h（P＞0.05）.A rather good linear correlation was observed between the new and old reagents（r=0.994 2,P＜0.01 for whole blood;r=0.995 2,P＜0.01 for diluted blood）.No statistical difference was found in whole blood sample of the new and old reagents（P＞0.05）.However,a statistical difference was observed in diluted sample（P＜0.01）. Conclusion The new reagent is better than the old reagent for Bio-Rad Variant II HbA1c assay and can meet clinical requirements better than the old reagent.