Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
Add to Cart
Easy to use high Accuracy Pregnancy home rapid Test CE certificate
| Product Name | Easy to use high Accuracy Pregnancy home rapid Test CE certificate |
| Formats | Strip(3mm)Device(4mm) Midstream(5mm) |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
A multi-center clinical evaluation was conducted comparing the results obtained using the hCG One Step Pregnancy Test Device (Urine) to another commercially available urine membrane hCG test. The study included 159 urine specimens, and both assays identified 88 negative and 71 positive results. The results demonstrated >99% overall accuracy of the hCG One Step Pregnancy Test Device (Urine) when compared to the other urine membrane hCG test.
hCG Reference Method
| Method | Other hCG Rapid Test | Total Results | |||
| hCG Test Device | Results | Positive | Negative | ||
| Positive | 78 | 0 | 78 | ||
| Negative | 0 | 72 | 72 | ||
| Total Results | 78 | 72 | 150 | ||
| Sensitivity: 100% (95%-100%)* | Specificity: 100% (95%-100%)* | ||||
| Accuracy: 100% (98%-100%)* | * 95% Confidence Intervals | ||||
