INTENDED USE

One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

SUMMARY AND EXPLANATION

One Step HCG Urine Pregnancy Test measures the presence of the hormone, Human Chorionic Gonadotrophin (HCG), in human urine for the early detection of pregnancy. During pregnancy, the placenta produces HCG after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after a missed period. As pregnancy progresses, urine contains higher levels of HCG at concentrations of 25mIU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mIU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mIU/ml with peak levels of 100,000 to 200,000mIU/ml.

PRINCIPLE

The HCG assay 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 to HCG. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the HCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-HCG monoclonal antibodies affixed on the test zone (“T”) will bind the HCG-gold conjugate complex, forming a pink line (“T”). Any sample will cause a pink colored line to appear in the control zone (“C”). This line is formed by the binding of polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly. In less than 5 minutes, levels of HCG as low as 25mIU/ml can be detected.

CONTENTS, STORAGE AND STABILITY

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

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

The test kit can be stored at room temperature (39F- 86F; 4℃-30℃) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.  Do not freeze.

MATERIALS REQUIRED BUT NOT PROVIDED

Specimen collection container, Timer

PRECAUTIONS

1. 1. FOR IN-VITRO DIAGNOSTIC USE ONLY (IVD), NOT for internal use
2. 2. Read directions for use carefully before performing this test. Perform each step exactly as described.
3. 3. Do not use beyond the expiration date marked on the foil pouch.
4. 4. Each Cassette Test can only be used once; do not re-use 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 REACH OF CHILDREN.