Bio-Rad VariantII糖化血红蛋白分析仪改良试剂应用评价

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

  • 摘要: 目的 对Bio-Rad VariantII糖化血红蛋白分析仪新试剂进行应用能力分析。方法 对Bio-Rad VariantII糖化血红蛋白分析仪改良试剂的精密度、稀释线性分析、全血模式与稀释模式、标本稀释后的稳定性、与改良前试剂相关性等评价。结果 批间精密度均≤1.4%,批内精密度均≤0.93%,全血模式精密度优于稀释模式。稀释线性理论值与实测值相关性良好(r=0.998 5,P<0.01)。稀释与全血模式比较差异无统计学意义;而改良前试剂的两种模式差异有统计学意义(P<0.01),其稀释模式结果高于全血模式。稀释样本室温10h存放稳定,与0h差异无统计学意义(P>0.05)。新试剂和改良前试剂有良好的相关性(全血r=0.994 2,P<0.01;稀释r=0.995 2,P<0.01)。新试剂和改良前试剂的全血模式测定结果差异无统计学意义(P>0.05),稀释模式结果则差异有统计学意义(P<0.01)。结论 Bio-Rad VariantII糖化血红蛋白改良新试剂优于改良前,能更好地满足临床质量要求。

     

    Abstract: 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.

     

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