PRINCIP
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.
| ime proizvoda | One Step HCG Urine Pregnancy Test |
| Brand Name | GOLDEN TIME, OEM-Buyer’s logo |
| Dozni oblik | In vitro dijagnostički medicinski uređaj |
| Metodologija | Imunološki hromatografski test koloidnog zlata |
| Specimen | Urin |
| Format | Skinuti se |
| materijal | Paper + PVC |
| Specifikacija | 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm |
| Osjetljivost | 25mIU/ml ili 10mIU/ml |
| Pakovanje | 1/2/5/7/20/25/40/50/100 testova/kutija |
| Preciznost | >=99,99% |
| Specifičnost | Nema prekoreaktivnosti sa 500mIU/ml hLH, 1000mIU/ml hFSH i 1mIU/ml hTSH |
| Vrijeme reakcije | 1-5 minuta |
| Vrijeme čitanja | 3-5 minuta |
| Rok trajanja | 36 mjeseci |
| opseg primjene | Svi nivoi medicinskih jedinica i kućni samotest. |
| Certifikat | CE, ISO, NMPA, FSC |
REAGENSI
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
OBAVEZNI MATERIJALI
Svaka torbica sadrži:
1.One One Step HCG Pregnancy Test strip
2.Desiccant
Svaka kutija sadrži:
1.One One Step HCG Pregnancy Test foil pouch
2. Čaša za urin
3.Paketni umetak
Nije potrebna nikakva druga oprema ili reagensi.
SKLADIŠTENJE I STABILNOST
Store test strip at 4~ 30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.