HCG Pregnancy Test Midstream
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|
|Specification||3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm|
|Sensitivity||25mIU/ml or 10mIU/ml|
|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|
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
Each pouch contains:
1.One One Step HCG Pregnancy Test midstream
Each box contains:
1.One One Step HCG Pregnancy Test foil pouch
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.
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.
1) Remove the test stick from the foil pouch
2) Remove the cap to expose the absorbent tip
3)Hold the stick by the thumb grip with the exposed absorbent tip pointing downward. Urinate on the absorbent tip only until it is thoroughly wet.
4)Lay the test stick down on a flat surface with the windows on top while you wait for the test result .Read the result in one to five minutes .DO NOT INTERPRET RESULT AFTER 5 MINUTES.
5) Discard the test device after single use in a dustbin.
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.