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山东博弘基因科技有限公司

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№ CN122922415AInvention
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一种肠道病毒EV71型抗原定量检测试剂盒

本发明公开了一种肠道病毒EV71型抗原定量检测试剂盒，属于体外诊断免疫检测技术领域。本发明试剂盒包括校准品、质控品、抗试剂、磁微粒试剂和发光底物，其中，抗试剂为异硫氰酸荧光素标记的EV71特异性捕获单抗和碱性磷酸酶标记的EV71特异性标记单抗；磁微粒试剂为异硫氰酸荧光素羊抗体偶联的羧基磁珠。本发明采用一对表位特异性不重叠、高基质耐受性的EV71‑VP1单克隆抗体配对，替代现有技术的多抗体系、适配体体系，大幅降低批间差异、提升检测稳定性与重复性；在临床应用方面，实现EV71抗原全自动精确定量，可输出病毒载量梯度，可用于轻症/重症感染风险辅助分层，突破传统抗原方法仅定性、无法预警重症的短板。

❖山东第一医科大学附属省立医院（山东省立医院）; 山东博弘基因科技有限公司吉兴照; 杨玉坤; 孙健; 靳晓英; 游文杰; 尚斌Oct 16, 2026§ 2/10 ClaimsG01N 33/569 (2006.01), G01N 33/543 (2006.01), G01N 33/58 (2006.01) +2