胶乳增强免疫比浊法测定糖化血红蛋白的方法学评价

目的应用美国，旌床实验室标准化委员会的标准化评价方案对胶乳增强免疫比浊法测定HbAlc进行方法学评价。方法依据标准化文件要求，分析胶乳增强免疫比浊法测定HbAlc的精密度、线性范围、回收率和干扰因素，并考察其与高效液相色谱法的相关性。结果该法总变异系数为3．19％（低值），3．53％（中值）和4．11％（高值）。平均回收率100．2％，在4．4％～13．5％范围内线性良好。胆红素在884μmol／L，三酰甘油在13．5mmol／L时对测定存在干扰。试剂和样本在低温保存时可稳定10天。该法与HPLC法结果明显相关，r=0．994，但整体略高于HPLC法的结果。结论胶乳增强免疫比浊法测定HbAlc方法符合NCCLS标准要求，适应临床需要。临床实验室在建立或引进新的检验项目时需要进行系统的方法学评价以验证检测的有效性和完整性。

Evluation of Latex Enhanced Immunoturbidimetry Asay for Determination of Glycated Hemoglobin

Objective To evaluate Latex enhanced immunoturbidimetry assay（LEITA） method for determination of HbAle with the National Committee for Clinical Lahoratory（NCCLS） protocol. Methods The precision,accuracy,linearity and in- terference of LEITA were analyzed,and the correlation was examined between LEITA and HPLC methods. Results The to- tal CV of LEITA were 3.19% （L） ,3.53% （M） and 4. 11% （H） respectively. The average recovery rate was 100. 2%,the linear range from 4.40/6o to 13.5 %. There was interference presence when total bilirubin was 884 μmol/L or triglyceride was 13.5 mmol/L of interference. The reagent and sample could be stable for 10 days when cryopreservation. There was signifi- cantly related between HPLC method and LEITA method, r= 0. 994. The overall result of LEITA method was slightly higher than HPLC method. Conclusion LEITA method for the HbAlc determination was in line with the NCCLS standard.