product

Urine HCG Pregnancy Test Strip

Short Description:

One Step HCG Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.


Product Detail

Test Procedure

OEM / ODM

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 Strip
material Paper + PVC
Specification 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm
Sensitivity 25mIU/ml or 10mIU/ml
Packing 1/2/5/7/20/25/40/50/100 tests/box
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 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

MATERIALS PROVIDED

Each pouch contains:

1.One  One Step HCG Pregnancy Test  strip

2.Desiccant

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.


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  • 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 strip from the foil wrapper

    2) Immerse the strip into the urine with the arrow end pointing toward the urine.  Do not cover the urine over the MAX (maximum) line.  You may take the strip out after a minimum of 15 seconds in the urine and lay the strip flatly on a non-absorptive clean surface. (See picture below)

    3) Read the result within 5 minutes .

    DO NOT INTERPRET RESULT AFTER 5 MINUTES.

    4) Discard the test device after single use in a dustbin.

    HCG Pregnancy Test Strip01

    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

    OEM / ODM

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