原则
The One Step HCG Pregnancy Test is a rapid qualitative one step assay for the detection of HCG in urine. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the HCG in the test samples with an extremely high degree of sensitivity. In less than 5 minutes, level of HCG as low as 25mlU/ml can be detected.
| 产品名称 | One Step HCG Urine Pregnancy Test |
| 品牌 | GOLDEN TIME, OEM-Buyer’s logo |
| 剂型 | 体外诊断医疗器械 |
| 方法 | 胶体金免疫层析法 |
| 标本 | 尿 |
| 格式 | 条 |
| 材料 | Paper + PVC |
| 规格 | 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm |
| 灵敏度 | 25mIU/ml 或 10mIU/ml |
| 包装 | 1/2/5/7/20/25/40/50/100 测试/盒 |
| 准确性 | >=99.99% |
| 特异性 | 与 500mIU/ml 的 hLH、1000mIU/ml 的 hFSH 和 1mIU/ml 的 hTSH 无交叉反应 |
| 反应时间 | 1-5分钟 |
| 阅读时间 | 3-5分钟 |
| 保质期 | 36个月 |
| 适用范围 | 各级医疗单位及家庭自检。 |
| 认证 | CE、ISO、NMPA、FSC |
试剂
One HCG pregnancy test strip per foil pouch.
Ingredients: Test device comprised colloidal gold coated with anti β-hCG antibody,
nitrocellulose membrane pre-coated goat anti mouse IgG and mouse anti α -HCG
提供的材料
每个小袋包含：
1.One One Step HCG Pregnancy Test strip
2.干燥剂
每个盒子包含：
1.One One Step HCG Pregnancy Test foil pouch
2.尿杯
3.包装插页
不需要其他设备或试剂。
储存和稳定性
Store test strip at 4~ 30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.
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