山东大学学报 (医学版) ›› 2020, Vol. 58 ›› Issue (10): 120-126.doi: 10.6040/j.issn.1671-7554.0.2020.0741
李焕杰1,2,欧兰香3,陈虹4,陈健2,耿军2,高志鹏5,王岩3,丁兴龙3,陈振3,朱之炜3,刘伦琴4,汪运山1,2
LI Huanjie1,2, OU Lanxiang3, CHEN Hong4, CHEN Jian2, GENG Jun2, GAO Zhipeng5, WANG Yan3, DING Xinglong3, CHEN Zhen3, ZHU Zhiwei3, LIU Lunqin4, Wang Yunshan1,2
摘要: 目的 开发一种快速检测SARS-CoV-2病毒的IgM-IgG抗体的胶体金免疫层析检测试剂盒,并优化研发及应用策略,分析IgM-IgG抗体联合检测在新冠病毒检测中的临床应用价值。 方法 表达纯化SARS-CoV-2病毒S蛋白的RBD和NTD结构域,通过胶体金制备工艺包被抗原及多克隆抗体,制备IgM-IgG抗体检测试剂盒;收集15例阳性患者的血清进行抗体检测分析,计算试剂盒检测的阳性率,分析SARS-CoV-2抗体IgM-IgG对病毒响应的过程。 结果 在15例核酸RT-PCR检测阳性的患者血清样本中,IgM-IgG联合抗体检测的阳性率为73.33%,其中IgM阳性占总标本数的53.33%,IgG阳性占总标本数的60.00%;5例境外人员中有3例为抗体阳性;对患者的流行病学分析发现,病毒感染1周以上的患者共7例,抗体检测全部为阳性;抗体检测试剂盒的灵敏度73.33%,特异性95.00%。 结论 IgM-IgG联合抗体检测法具有快速、方便、易操作等特点,可以作为核酸检测的辅助手段对疑似患者(尤其是境外人员及无症状患者)进行初筛;且IgM-IgG的检测结果可以作为推测患者病毒感染过程的依据;快速检测IgM-IgG抗体将为COVID-19疾病的诊断和治疗提供帮助。
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