四氮唑蓝法检测果糖胺的分析性能评价

目的：评估四氮唑蓝法检测血清果糖胺（即糖化血清蛋白,GSP）的分析性能。方法：参照CLSI方法学评价方案,评价四氮唑蓝法检测GSP的线性、稳定性及干扰因素等。结果：在0~6 mmol·L^-1的6个浓度范围内测定线性良好,批内重复性良好,分析灵敏度为0.05 mmol·L^-1,血清GSP和血浆GSP测定结果差异有统计学意义（P〈0.05）。总胆红素含量为8 mg·L^-1时影响较小,偏差〈5%;为24 mg·L^-1时影响较大,偏差〉10%。当维生素C（Vit C）含量为10 mg·L^-1时,偏差为10%;随着Vit C浓度的增大,偏差也越大,影响越大。四氮唑蓝法检测GSP 4℃条件下稳定达7 d,对结果无影响。健康人血清GSP水平与年龄及性别无关,参考范围验证通过。结论：四氮唑蓝法检测果糖胺重复性、稳定性良好,适合临床应用。

Evaluation of performance of nitroblue tetrazolium method for assaying serum fructosamine

Objective： To analyze the performance of nitroblue tetrazolium assay for serum fructosamine（ GSP）. Methods： The stability,linearity and interference factors of nitroblue tetrazolium method for GSP were evaluated according to the protocol from America CLSL. Results： The linear range at 0-6 mmol·L^-1was good. The method had good repeatability. The sensitivity was 0. 05 mmol·L^-1. The results of EDTA-K2 anticoagulant and serum samples were shown significant difference（ P〈0. 05）. Total bilirubin at 8 mg·L^-1had weak influence on the results of GSP and the deviations thereof were below 5%. However total bilirubin at 24 mg·L^-1obviously influenced the results with deviations thereof more than 10%. When the Vit C（ 10 mg·L^-1） were added,the deviations became higher. Along with increasing the concentration of Vit C,the influence on the result became greater. GSP in serum detected by nitroblue tetrazolium method were stable at 4 ℃ for 7 days. The GSP levels in healthy adults were not related to the age and gender. The reference range was verified. Conclusion： The nitroblue tetrazolium method has good repeatability,excellent stability,and is suitable for clinical application.