摘要
目的建立脂蛋白相关磷脂酶A2免疫荧光层析定量测定方法,并对其进行临床应用评价。方法利用双抗体夹心法,研制脂蛋白相关磷脂酶A2时间分辨免疫荧光层析试纸条,通过检测其线性范围、最低检测限、精密度等指标进行实验室性能评估;选取230例临床血清样本,同时使用本方法和美国Diadexus公司的脂蛋白相关磷脂酶A2试剂进行比对试验,进行临床应用评估。结果脂蛋白相关磷脂酶A2免疫荧光层析定量测定试剂线性范围为20μg/L^1 000μg/L,最低检测限为10μg/L,重复检测不同浓度的脂蛋白相关磷脂酶A2蛋白,批次内及批次间变异系数均小于10%;本试剂与美国的Diadexus公司的试剂检测临床样本的总符合率为90.87%,Kappa值为0.804,相关系数r=0.968,相关性具有统计学意义(P<0.01)。结论免疫荧光层析法测定脂蛋白相关磷脂酶A2,各项分析指标均能达到临床要求,且便捷准确,可用于临床血清样本的快速检测。
Objective To explore the quality of a reagent for quantitative immunofluorescence chromatography assay and evaluate the clinical value for diagnosis of lipoprotein-associated phospholipase A2. Methods Based on the technology of double-antibody sandwich method,the lipoprotein-associated phospholipase A2 immunofluorescence chromatography strip was established.The performance of kit was evaluated by the range of linearity,sensitivity,accuracy and precision. The kit for Lipoprotein-Associated Phospholipase A2 was compared with Diadexus PLAC Test ELISA Kit made in USA by the parallel experiment in 230 serum specimens.The clinical application were evaluated. Results The minimum limit of detection was 10μg/L.The linear range of lipoprotein-associated phospholipase A2 kit was 20 ~ 1 000μg/L.The coefficient of variation values for low,median and high concentration calibrators respectively were all less than 10%.The total coincidence rate of lipoprotein-associated phospholipase A2 kit and PLAC Test ELISA Kit was 90.87%,Kappa was 0.804,r = 0.968.The date showed there was no significant difference between the results of two kits. Conclusions The immunofluorescence chromatography method targeted at the lipoprotein-associated phospholipase A2 protein was convenient,rapid and sensitive.It is an excellent technique and readily applicable for clinical use.
出处
《中南医学科学杂志》
CAS
2017年第5期523-527,共5页
Medical Science Journal of Central South China
基金
基金项目:2015年科技型中小企业技术创新资金(合同编号:201501010052)
关键词
脂蛋白相关磷脂酶A2
免疫荧光层析
动脉粥样硬化
ipoprotein-associated phospholipase A2
immunofluorescence chromatography
atherosclerosis
