HCG Pregnancy Test Cassette
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.
ASSAY PROCEDURE
1.DETERMINATION OF TEST DATE
The test could be used from the first missing date.
2.SPECIMEN COLLECTION AND HANDLING
The One Step HCG Pregnancy Test is formulated for use with fresh urine specimens. The test should be used right after the specimen collection. Urine cup should be used to collect specimens, and the urine does not require any special pretreatment.
3.TEST PROCEDURE
1) Remove the test device from the foil wrapper by tearing along the slice
2) Using the urine dropper, withdraw the urine sample from the specimen cup and slowly dispense 3-5 drops (approximately 120uL) into the circular sample well, being careful not to overfill the absorbent pad.
3).Read result within five minutes .
DO NOT INTERPRET RESULT AFTER 5 MINUTES.
4) Discard the test device after single use in an appropriate place
Negative：If only one pink line appears in the control area, you can assume that you are not pregnant.
Positive :If two pink lines appear both in the control area and test area, you can assume that you are pregnant.
Invalid:If there is no distinct pink-purple colored band visible both in the TEST area and CONTROL area, or only a pink-purple colored band visible in Test area, the test is invalid .It is recommended that in this case the test be repeated.
