两种高密度脂蛋白胆固醇测定试剂盒的性能评价

目的比较免疫抑制直接法(AB法)与选择性抑制法(PPD法)两种试剂盒,评价其在测定高密度脂蛋白(HDL-C)上的性能。方法在全自动生化分析仪上,分别检测两种试剂的精密度、测定范围、抗干扰能力,以及临床测定标本结果的相关性。结果 AB法试剂和PPD法试剂的批内精密度均1%,批间精密度均2%,均有较好的精密度。AB法试剂测定范围为0.04~4.0mmol/L,PPD法试剂为0.06~2.60mmol/L。AB法试剂和PPD法试剂在干扰物质Hb5.0g/L时,对结果没有明显影响,在干扰物质TG13.0mmol/L时,用AB法试剂测定HDL-C没有明显影响,PPD法试剂在干扰物质TG≥13.0mmol/L时,检测结果偏差15%。两种试剂测量临床样本具有良好的相关性,回归方程为Y=0.867 X+0.164(r=0.982,P0.05)。结论 AB法试剂抗干扰能力优于PPD法试剂;两种试剂测定方法具有良好的相关性,符合临床检测要求。

Performance evaluation of two kinds of determination kit for high density li-poprotein cholesterol

Objective To compare two kits used respectively on the immune inhibitor direct method and selective inhibitor direct method so as to evaluate the performance on measuring high density lipoprotein cholesterol（HDL-C）.Methods On fullautomatic biochemical analyzer,the A kit measuring method is immune inhibitor direct method and the B kit measuring method is selective inhibitor direct method.The precision,measuring range,anti-interference capability and the correlation of the results of clinical specimens were measured by two kits respectively.Results The within run precision and between run precisionof A kit and B kit are both 〈1% and 〈2%,respectively.The two kits have both preferable precision.The measuring range of A kit and B kit are 0.04~4.0mmol/L and 0.06~2.60mmol/L,respectively.The analyzed results by two kits have not obvious impact when interfering substance Hb〈5.0g/L.The HDL-C results by A kit have not obvious impact when interfering substance TG〈13.0 mmol/L.The bias of analyzed results by B kit reached 15% when interfering substance TG≥13.0mmol/L.The correlation of the results of clinical specimens of two kits was preferable（Regression equation Y=0.867X＋0.164;r=0.982）.Conclusion The anti-interference capability of A kit was better than that of B kit.The measuring methods by two kits were preferable comparability.They all meet the needs of clinical detection of specimens.