PRINCIPLE
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.
| Product Name | One Step HCG Urine Pregnancy Test |
| Brand Name | GOLDEN TIME, OEM-Buyer’s logo |
| Dosage Form | In Vitro Diagnostic Medical Device |
| Methodology | Colloidal gold immune chromatographic assay |
| Specimen | Urine |
| Format | Cassette |
| material | ABS |
| Specification | 2.5mm 3.0mm 4.0mm 5.0mm |
| Packing | 1/2/5/7/20/25/40/50/100 tests/box |
| Sensitivity | 25mIU/ml or 10mIU/ml |
| Accuracy | >=99.99% |
| Specificity | No across reactivity with 500mIU/ml of hLH, 1000mIU/ml of hFSH and 1mIU/ml of hTSH |
| Reaction Time | 1-5 minutes |
| Reading Time | 3-5 minutes |
| Shelf Life | 36 months |
| range of application | All levels of medical units and home self-test. |
| Certification | CE, ISO, NMPA, FSC |
REAGENTS
One HCG pregnancy test 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
MATERIALS PROVIDED
Each pouch contains:
1.One One Step HCG Pregnancy Test cassette
2.Desiccant
3.A dropper
Each box contains:
1.One One Step HCG Pregnancy Test foil pouch
2.Urine cup
3.Package insert
No other equipment or reagents are needed.
STORAGE AND STABILITY
Store test strip at 4~ 30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.