免疫抑制法直接测定血清高密度脂蛋白胆固醇试剂盒的评价

Evaluation of a Direct Immunoinhibition Mothod for Measuring High Density Lipoprotien Cholesterol

目的 :评价免疫抑制法直接测定血清高密度脂蛋白胆固醇 (HDL -C)试剂盒是否符合临床应用要求。方法 :将免疫抑制法与磷钨酸———镁法 (PTA)和选择性抑制法进行比较 ,并分析其线性范围、精密度、准确度和干扰因素。结果 :免疫抑制法 (Y)与PTA法 (X1)的回归方程为Y =0 .993X1+ 0 .2 1 3,r =0 .981 ;与选择性抑制法 (X2 )的回归方程为Y =1 .0 1X2 + 0 .1 77) ,r =0 .971 ;Y与X1、X2 所测得的均值无显著差异 (P >0 .0 5 ) ;HDL -C浓度在 0 5 1～ 2 .5 5mmol/L范围内线性良好。对高、中、低血清标本进行精密度测定 ,批内CV值分别为 1 35 %、1 6 7%和 2 0 1 % ,日间CV值分别为 2 78%、3 1 4%和 3 43%。回收率为 97 8%～ 1 0 0 .9% ,平均回收率为 99 2 %。胆红素 ( <2 5 0 μmol/L)、血红蛋白 ( <5 g/L) ,抗坏血酸 ( <2 0 0 μmol/L)、TG( <1 0mmol/L)不干扰测定。 结论 :日本和光公司生产的免疫抑制法直接测定血清HDL -C试剂盒符合临床应用要求 。

Objective:To evaluate whether a kit of direct immunoinhibition assay for measuring high density lipoprotien cholesterol(HDL C) was suitable for clinical applied requirement or not.Methods:The immunoinhibition method was compared with PTAmethod and selective inhibition method.Moreover,Its linear range,the precision,the accuracy and the interfere factors were analyzed.Results:The regression equation of immunoinhibition method(Y) and PTA method(X 1)was Y=0.993X 1+ 0.213 , r =0.981;and inhibition method(X 2) was Y=1.01X 2+0.177, r =0.971.There were no significant difference among mean value determined by Y,X 1,X 2( P >0.05).The linear range was 0.51～2.55mmol/L.The precision of high,middle,low HDL C concentration specimen were tested,the CV in within run were 1.35%,1.67%,and 2.01%,the CV in the daytime run were 2.78%,3.14%,and 3.43%.The recovery rate were 97.8%～100.9%.The interference of bilirubin(<200μmol/L),hemoglobin(<5g/L),ascorbic acid(<200μmol/L) and TG(<10mmol/L) were insignificant.Conclusion:The kit of direct immunoinhibition assay producted by Co.Heguang,Japan for ditermination HDL C is suitable clinical appiled requirement,and it can be used in full automatic analysis.