for export factory direct sales early pregnancy card

Intended Use

The One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay used for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples, helping professionals and home users detect pregnancy early.

SUMMARY AND EXPLANATION

The One Step HCG Urine Pregnancy Test measures the presence of Human Chorionic Gonadotrophin (HCG) in human urine to detect pregnancy early on. During pregnancy, the placenta produces HCG once the embryo attaches to the uterine lining. This test can detect pregnancy on the first day after a missed period. As pregnancy progresses, urine contains higher levels of HCG, reaching concentrations of 25 mIU/ml or higher. The HCG concentration in non-pregnant women is typically 5.0 mIU/ml. At the time of the last missed menstrual period, urine HCG levels are approximately 100 mIU/ml, with peak levels ranging from 10,000 to 20,000 mIU/ml.

PRINCIPLE

The HCG test is a rapid one-step test based on immunochromatographic technology. A membrane with an absorbent pad over a strip of fiber glass paper is impregnated with a colloidal conjugate of gold particles and monoclonal antibodies against HCG. Additional absorbent pads at the end of the test absorb excess sample fluid. The urine sample is introduced into the chromatographic membrane. As it comes into contact with the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the HCG antigen will bind to the antibodies in the colloidal solution. As the conjugate moves along the membrane, the anti-HCG monoclonal antibodies attached to the test zone (“T”) will bind the HCG-gold conjugate complex, resulting in a pink line (“T”). Any sample will produce a pink line in the control zone. ne (“C”). This line is formed by the binding of polyclonal antibodies (Anti-mouse IgG) attached to the control zone on the sample-colloidal gold conjugate. The presence of this line indicates that the test was performed correctly. In less than 5 minutes, HCG levels as low as 2.5 mIU/ml can be detected.

CONTENTS, STORAGE AND STABILITY

Each box contains: 1 foil pouch and Instructions for use.

Each pouch contains: 1 Step HCG Urine Pregnancy Test Cassette, 1 Dropper, and 1 Desiccant.

The test kit can be stored at room temperature (39°F–86°F; 4℃-30℃The expiration date must be indicated on the sealed pouch. The test kits should be stored away from direct sunlight, moisture, and heat. Do not freeze.

REQUIRED MATERIALS BUT NOT PROVIDED

Specimen collection container, Timer

PRECAUTIONS

1. 1. FOR IN-VITRO DIAGNOSTIC USE ONLY (IVD), NOT for internal use
2. 2. Read the usage instructions carefully before conducting this test. Follow each step exactly as described.
3. 3. Do not use the product beyond the expiration date indicated on the foil pouch.
4. 4. Each Cassette Test can only be used once; do not reuse the Cassette Test.
5. 5. Do not use the Cassette Test if the foil pouch is damaged.
6. 6. Once the foil pouch has been opened, the Cassette Test should be used immediately.
7. 7. Discard each Cassette Test after use. Treat urine samples and used test devices as if they were potentially infectious. Avoid contact with skin.
8. 8. Keep out of children's reach.