INTENDED USE

One Step HCG Urine Pregnancy Test Kit (Strip) 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 the 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.

CONTENTS

Each box contains:  the pouch and the operating instruction.

Each pouch contains: the Pregnancy Test Strip and the Desiccant.

STORAGE AND STABILITY

The test kit can be stored at room temperature (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.

TEST PROCEDURE

1. SAMPLE COLLECTION AND HANDLING

To perform this test, collect a urine sample into a clean and dry container. Urine samples collected first thing in the morning are ideal because they generally contain higher concentration of HCG. However, urine samples collected at any time of the day may also be used.

2. DIRECTIONS FOR USE

· Bring the sealed pouch to room temperature.

· Remove the strip from the foil pouch.

· Immerse the strip into the urine with the arrow end pointing toward the urine cup. Do not cover the urine over the MAX (maximum) line.

· Take the strip out of the cup after a minimum of 15 seconds and lay it flatly on a non-absorptive, clean surface.         

· Read the result in 5 minutes.

· Discard the test device after a single use. 

3. HOW TO READ THE RESULT

Positive: If two pink/purple colored lines appear on the one step HCG pregnancy Test, one in the control area and one in the test

area, then this means HCG has been detected in the urine and there is a strong possibility of pregnancy. The lines seen may be

faint and one line may be lighter than the other; however this is still a positive result. The lines do not have to match in strength or

color.

Negative: If one colored pink/purple line appears in the control area on the one step HCG pregnancy Test and there is no line in

the test area, then this indicates a negative result. This means no HCG has been detected in the urine. This indicates you are

either  not pregnant or you have tested tooearly. If you are not sure repeat the test in 48 hours.

Invalid: If no lines appear anywhere on the control zone, the test is invalid and repeat the test using another strip.

Invalid Test Results can be caused by:

· The absorbent tip not being wetted thoroughly.

· Reading the test result too early or too late. A 5 minutes reaction time is required.

For further information, see LIMITATIONS OF THE PROCEDURE.