两种高密度脂蛋白胆固醇测定试剂盒的性能评价  

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

作　　者：熊晓芸[1] 徐光[1] 朱宝立[1] 

机构地区：[1]江苏省疾病预防控制中心,南京210009

出　　处：《江苏预防医学》2014年第6期3-5,共3页Jiangsu Journal of Preventive Medicine

基　　金：卫生部卫生行业科研专项(200902006);江苏省医学领军人才与创新团队项目(LJ201130)

摘　　要：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Hb〈5.0g/L时,对结果没有明显影响,在干扰物质TG〈13.0mmol/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,P〈0.05）。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。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.

关 键 词：高密度脂蛋白 免疫抑制直接法 选择性抑制法 

分 类 号：R11[医药卫生—公共卫生与预防医学]