圣湘生物公告，公司产品耶氏肺孢子菌、新型隐球菌、曲霉核酸检测试剂盒（荧光PCR法）近日获得国家药品监督管理局颁发的《医疗器械注册证》，注册类别为境内第三类体外诊断试剂，注册证有效期至2030年6月19日。该产品用于体外定性检测人痰液、肺泡灌洗液中深部感染真菌，包括耶氏肺孢子菌、新型隐球菌和曲霉DNA核酸。产品采用实时荧光PCR技术，一次检测即可覆盖三大高危肺部真菌病原体，进一步丰富了公司呼吸道类产品生态，为临床提供更高效精准的检测方案。
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