在呼吸道领域，本次获批的两款呼吸道"小联检"产品具备高灵敏度、高特异性、操作简便等优势，最快 30分钟即可出具报告。其中，肺炎链球菌、流感嗜血杆菌和卡他莫拉菌是社区获得性肺炎及儿童呼吸道 感染的主要致病菌，大肠埃希菌、鲍曼不动杆菌及嗜麦芽窄食单胞菌多见于医院获得性肺炎及呼吸机相 关肺炎患者，常累及基础疾病多、免疫功能受损或接受侵入性操作的高危人群。在呼吸道感染临床表现 高度相似、经验性用药风险较高的背景下，依托快速、精准的核酸检测尽早明确致病菌，对于实现精准 用药、降低耐药风险并改善患者预后具有重要价值。至此，公司"小联检"系列产品已扩展至10款，进一 步完善了圣湘"6/3+X呼吸道感染核酸快速检测"体系，可更好地应对当前多病原共流行和混合感染等复 杂局面，提供更加灵活、高效的检测选择，为临床精准用药和抗菌药物管理提供有力支撑。 针对EB病毒的普遍感染及潜伏感染特性，在精准监测领域，本次获批上市的EB病毒核酸检测试剂盒 （荧光PCR法）实现了重要技术升级，提升了检测灵敏度，并完善了对血浆、全血等多种标本类型的支 持能力。除引起传染性单核细胞增多症外，EBV还可导致慢性活动性EBV感染、EBV相关噬血细胞性淋 ...

Core Insights - Shengxiang Bio (688289.SH) has recently obtained three product certifications and registrations, including two Class III medical device registrations and one EU CE IVDR certification [1][2] - The newly launched products include a Norovirus nucleic acid detection kit and a combined detection kit for A group rotavirus, Norovirus, and F group enteric adenovirus, which will enhance the rapid identification and precise diagnosis of diarrheal pathogens [1] - The EB virus detection kit has received EU CE IVDR certification, expanding the company's herpes virus testing product line and demonstrating compliance with international quality and technical standards [2] Product Certifications - The company received the following certifications: - Norovirus nucleic acid detection kit (PCR-fluorescent probe method), registration number: 国械注准20253402188 [1] - A group rotavirus/Norovirus/F group enteric adenovirus nucleic acid detection kit (PCR-fluorescent probe method), registration number: 国械注准20253402226 [1] - EB virus nucleic acid detection kit (fluorescent PCR method), registration number: No.V120745520012Rev.00 [1] Market Impact - The introduction of the Norovirus and combined detection kits is expected to significantly improve clinical capabilities in identifying diarrheal pathogens, particularly benefiting vulnerable populations such as children and the elderly [1] - The EB virus is commonly associated with various diseases, including infectious mononucleosis and several types of cancer, highlighting the importance of the newly certified detection kit in public health [2] - The company aims to accelerate the global rollout of innovative products, contributing to public health and precision medicine [2]