診断薬
使用贵金属胶体金、提供受托制造体外诊断药、各种检验套组。
除了历经长年培育累积的金胶体制造技术之外,还有将蛋白固定于金胶体之技术、抑制蛋白对金胶体的非特异性吸附之技术、增强抗原抗体之技术等,拥有比过去更具高性能的免疫层析试纸分析法试药相关的广泛/全面。
从体外诊断用原材料的供应到OEM制造,一律透过以ISO13485系统进行管理的安心生产体制来提供产品。
■受托内容
- 共轭金胶体溶液
- 开发及制造检查用试纸(免疫层析试纸分析法※)
- OEM制造
![OEM产品图片1](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block01_01.jpg)
![OEM产品图片2](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block01_02.jpg)
![OEM产品图片3](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block01_03.jpg)
■制造登记体制
- 体外诊断用医药品制造业登记
- 取得ISO13485认证
![ISO13485认证](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_tuv.gif)
※透过免疫层析试纸分析法的检出原理
检体中有抗原(病毒等)存在时,与金胶体标志抗体结合,形成复合体。这种复合体会因毛细现象而移动细胞膜,进一步与,被固定于判别部位的捕捉抗体结合并形成红色条状。以这一连串的制程判断是否有抗原的存在。
试纸说明图示
![[试纸说明图示] (检体的流程)左起:检体、胶体金、金胶体标志抗体、捕获抗体](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block02_01.jpg)
Reel-to-reel system
![Reel-to-reel system](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block02_001.jpg)
自动装盒装置
![自动装盒装置1](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block02_002.jpg)
![自动装盒装置2](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block02_003.jpg)
自动包装装置
![自动包装装置](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block02_004.jpg)
产品检查
![产品检查](https://prod-cn-bucket-wpmedia-oss-upload.oss-cn-shanghai.aliyuncs.com/wp-content/uploads/sites/images/ex/cn/products/images/f03/img_block02_005.jpg)