IVD CE certificate H

Intended Use of HCG Test Strip (Urine/ serum)

The HCG Rapid Test Device (Urine/Serum) is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

Principle of HCG Test Strip (Urine/ serum)

The HCG Rapid Test Device (Urine/Serum) detects human chorionic gonadotropin through visual interpretation of color development in the internal strip. Anti-hCG antibodies are immobilized on the test region of the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti-hCG antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient hCG in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Catalog and detail information of HCG Test Cassette ( Urine/Serum)

1. Open the sealed pouch by tearing along the notch.

2. Remove the test from the pouch.

3. Immerse strip into the urine with the arrow end pointing towards the urine. Do not past the MAX line.

4. Take the strip out after 3 seconds and lay the strip flat on a clean, dry and onabsorbent surface (e.g., mouth of the urine container).

5. Wait for colored bands to appear. Depending on the Concentration of HCG in the test specimen , positive results may be observed in as short as 40 seconds. However to confirm negative results, the complete reaction time (5 minutes) is required.

Do not read results after 10 minutes

INTERPRETATION OF RESULTS

1. Negative: Only one color band appears on the Control region. No apparent band on the Test region. There is no pregnancy.

2. Positive: Distinct color bands appears on the Control and Test regions. Both Test line and Control line indicate that you are pregnant. Color intensity of the Test bands may vary. Different stages of pregnancy have different concentrations of HCG hormone.

3. Invalid: No visible bang at all. Repeat test with a new test kit.

STORAGE AND STABILITY

The test kits can be stored at room temperature (18 to 30℃) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTION

1. For in vitro diagnostic use only.

2. Do not use test kit beyond expiry date.

3. The test device should not be reused.

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