为了建立快速灵敏的乙肝磁性免疫层析检测方法，选用前S1抗原作为乙肝检测标志物，将前S1抗原的特异性单抗偶联到磁珠表面，制备了乙肝的特异性磁性纳米探针，并以此探针作为检测标记物制备了乙肝的磁性试纸条。采用乙肝临床血样，对所构建磁性试纸条的检测灵敏度、稳定性和重现性等检测性能进行了评价，并和市售的乙肝ELISA试剂盒进行了对比分析。与ELISA试剂盒的对比结果显示，研究所建立的乙肝磁性试纸条灵敏度较ELISA法高2倍，具有较好的稳定性（25℃可保存半年）和重现性；这两种方法对441份临床血样的检测结果一致性高达97％。研究可为今后乙肝的床边早期诊断产品开发提供技术支撑。%To establish a rapid and sensitive detection method for HBV in serum samples of people , in this study, PreS1 antigen was selected as markers for HBV detection .Specific antibody against PreS 1 was coupled onto the surface of magnetic beads to prepare mag-netic nanoprobe .HBV magnetic test strip labeled by magnetic nanoprobe was constructed .HBV clinical serum samples were used as detection samples .The detection performance of magnetic test strip including sensitivity , stability and repeatability was performed .The developed magnetic test strip was compared with commercially ELISA kit of HBV .Comparison results showed that the sensitivity of our test strip was two folds higher than ELISA method .Good stability ( can save half a year in 25 ℃) and reproducibility was assessed for the magnetic test strip .The consistency of these two methods was as high as 97%( n=441 ) .Our study can provide technological sup-port of point of care products for early diagnosis of HBV .
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