PRINSIPYO
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.
| pangalan ng Produkto | One Step HCG Urine Pregnancy Test |
| Tatak | GOLDEN TIME, OEM-Buyer’s logo |
| Form ng Dosis | In Vitro Diagnostic Medical Device |
| Pamamaraan | Colloidal gold immune chromatographic assay |
| Ispesimen | Ihi |
| Format | Maghubad |
| materyal | Paper + PVC |
| Pagtutukoy | 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm |
| Pagkamapagdamdam | 25mIU/ml o 10mIU/ml |
| Pag-iimpake | 1/2/5/7/20/25/40/50/100 na pagsubok/kahon |
| Katumpakan | >=99.99% |
| Pagtitiyak | Walang buong reaktibiti na may 500mIU/ml ng hLH, 1000mIU/ml ng hFSH at 1mIU/ml ng hTSH |
| Oras ng Reaksyon | 1-5 minuto |
| Oras ng Pagbasa | 3-5 minuto |
| Shelf Life | 36 na buwan |
| saklaw ng aplikasyon | Lahat ng antas ng mga medikal na yunit at pagsusuri sa sarili sa bahay. |
| Sertipikasyon | CE, ISO, NMPA, FSC |
MGA REAGENTS
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
MGA MATERYAL NA IBINIGAY
Ang bawat pouch ay naglalaman ng:
1.One One Step HCG Pregnancy Test strip
2.Desiccant
Ang bawat kahon ay naglalaman ng:
1.One One Step HCG Pregnancy Test foil pouch
2. Tasa ng ihi
3.Package insert
Walang ibang kagamitan o reagents ang kailangan.
STORAGE AT KATATAGAN
Store test strip at 4~ 30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.