近日，深圳市亚辉龙生物科技股份有限公司自主研发的可溶性CD146检测试剂盒（化学发光法）获得了 广东省药品监督管理局批准的医疗器械注册证。此举标志着亚辉龙在中枢神经系统疾病检测领域实现重 大突破，至此亚辉龙国内化学发光试剂产品累计已达到173个。 人类白细胞分化抗原CD146（CD146）是Ⅰ型跨膜糖蛋白，非Ca2+依赖性细胞黏附分子，属于免疫球蛋 白超家族。存在膜型和可溶性两种形式，膜型CD146的胞外区经过金属蛋白酶切割等生理过程，从细胞 表面脱落进入组织液中，形成可溶性CD146（sCD146）。 颠覆传统技术局限，彰显全球顶尖临床检测价值 强强联合，共铸医学创新里程碑 亚辉龙可溶性CD146检测试剂盒（化学发光法）为全球首创技术成果，由亚辉龙与阎锡蕴院士团队联合 开发。阎锡蕴教授是中国科学院院士、著名纳米生物学家，长期深耕肿瘤免疫学与纳米酶领域，首 创"纳米酶"概念并发现肿瘤血管新靶点CD146，成果获国家自然科学奖二等奖等多项重要荣誉。 sCD146的产学研转化成果，不仅革新了中枢神经系统免疫性炎性脱髓鞘疾病的诊断模式，更强化了我 国在该疾病诊断领域的国际领先地位，为全球患者带来更优质、高效的诊断解 ...

Core Insights - Shenzhen Yahui Long Biotechnology Co., Ltd. has received approval for its self-developed soluble CD146 detection kit (chemiluminescence method) from the Guangdong Provincial Drug Administration, marking a significant breakthrough in the detection of central nervous system diseases [1][2] - The company is the first globally to offer a soluble CD146 detection kit for cerebrospinal fluid, bringing its total number of domestic chemiluminescent reagent products to 173 [1] Group 1: Product Development and Innovation - The soluble CD146 detection kit demonstrates a notable increase in sCD146 concentration in cerebrospinal fluid among patients with multiple sclerosis (MS) and neuromyelitis optica, addressing the challenge of early and accurate diagnosis in these conditions [1][2] - Traditional laboratory testing methods have limitations, including complex procedures and long detection cycles, which the new chemiluminescence method overcomes by simplifying operations and enhancing sensitivity and specificity [1] Group 2: Clinical Implications and Market Position - The introduction of the soluble CD146 detection kit is expected to transition the field of central nervous system immune inflammatory demyelinating diseases from "diagnosable" to "precise and early diagnosis," laying a crucial foundation for disease intervention and prognosis improvement [2] - The collaboration with Academician Yan Xiyun, a prominent figure in nanobiology and tumor immunology, highlights the innovative nature of this project and strengthens China's international position in the diagnostic field for these diseases [2]