- Open the foil pouch and take out the test. Remove the cap.
- Prepare a urine cup with at least 3cm of urine sample.
- Hold the Test Stick vertically, carefully dip it into the urine for at least 15 seconds so that adequate urine goes into the absorbent pad.
- Recap the Test Stick and lay it on a flat surface with the Result Window facing up. Read test results at 5 minutes after the "C" (control) Lines appear.
INTERPRETATION OF RESULTS
As the test kit begins to work, a purple line (Control Line indicated as letter "C" on the cassette) will appear in the result window. If the "C" line appears as expected it means that sufficient urine was present to activate the test, that it is working properly, and that the reading has begun to take place.
The result window in 25, 100, 500, 2000, 10000 mIU/ml columns indicates the test results. If another purple line appears at the result window, this band is the Test Line (indicated as letter "T" on the cassette).
POSITIVE:
25mIU/ml Zone: Two purple color lines in the 25 mIU/ml Column of the Result Window, regardless of what the other columns show, indicate that the specimen contains about 25 mIU/ml of hCG. See Fig. 2
NEGATIVE:
If there is only one purple color line in the 25 mIU/ml Column, regardless of what the other columns show, this indicates that the hCG level in the urine is less than 25 mIu/ml.
Note: The "T" line and the "C" line do not have to have the same color intensity. One may be fainter or darker than the other.
You can also determine the approximate hCG level in your urine by comparing your test results to the diagrams below. This will be an estimate (depending on the concentration of your urine) of the amount of pregnancy hormone circulating in your blood stream.
 100mIU/ml Zone: If there are two purple color lines in the 100 mIU/ml Column of the Result Window, this indicates that the specimen contains about 100 mIU/ml of hCG. See Fig. 3.
500mIU/ml Zone: If there are two purple color lines in the 500 Column of the Result Window, this indicates that the specimen contains about 500mIU/ml. See Fig 4.
2,000mIU/ml Zone: If there are two purple color lines in the 2000 Column of the Result Window, this indicates that the specimen contains about 2000mIU/ml. See Fig. 5
10,000 mIU/ml Zone: If there are two purple color lines in the 10000 Column of the Result Window, this indicates that the specimen contains about 10000 mIU/ml or higher. See Fig. 6
INVALID: The test is invalid if no color line appears in the "C" line area of the corresponding Result Window. A distinct purple line should always appear in the "C" line area of each Result Window.
Limitations of the Test
- In addition to pregnancy, hCG has been found in patients with both gestation and non-gestation trophoblastic diseases.
- Although the test can detect and indicate hCG levels at 25 mIU/ml and higher, a low incidence of false results can occur.
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