The One Step Pregnancy Test Strip is an in vitro diagnostic home use test device intended for the rapid detection of Human Chorionic Gonadotropin (HCG) in urine to aid in the early detection of pregnancy. You can easily carry out this test yourself. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
HOW DOES IT WORK?
Human chorionic gonadotropin (hCG) is a hormone, produced by the developing placenta and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone. When the sample end of the test is dipped in the urine specimen, the urine specimen is absorbed by the strip and migrates along the strip. When hCG in the sample reaches the Test Zone region of the membrane, it will form a colored line. Absence of this colored line suggests a negative result.
A colored line will appear at the Control Zone region if the test has been performed properly.
CONTENT OF THE TEST KIT
1. One pouch containing a test strip.
2. Insert with instructions for use.
WHAT ELSE DO YOU NEED?
1. A clean, dry, plastic or glass container to collect the urine.
2. Timer or clock.
1. This kit is for external use only. Do not swallow.
2. Discard after first use. The test strip cannot be used more than once.
3. Do not use the test after the expiration date printed on the foil pouch.
4. Do not use the kit if the pouch is punctured or not well sealed.
5. Keep out of the reach of children.
STORAGE AND STABILITY
1. Store at 39°F to 86°F (4ºC to 30ºC) in the sealed pouch up to the expiration date.
2. Keep away from direct sunlight, moisture and heat.
3. DO NOT FREEZE.
4. You should perform the test soon after opening the pouch. You should keep the test in a dry environment before use.
WHEN TO COLLECT URINE FOR THE TEST?
For many women, HCG may be detectable with this test by the day after the missed period. Any urine specimen will work for Pregnancy Testing but the first morning urine specimen is optimal because of its highest concentration of HCG.
HOW TO COLLECT URINE?
Urine specimens may be collected in any clean, dry, plastic or glass container.
HOW TO DO THE TEST?
1. The test strip and urine have to be at room temperature 59-86ºF (15-30°C) for testing.
2. Remove the test strip from the sealed pouch.
3. Immerse the strip into the urine with the arrow pointing towards the urine. Take the strip out after 3 seconds and lay the strip flat on a clean, dry, non-absorbent surface (such as the mouth of the urine container).
IMPORTANT: Do not allow the urine level to exceed the MAX (marker line), otherwise the test will not perform correctly.
4. Read results in five minutes. Positive results may sometimes appear as early as one minute but you should wait the full 5 minutes before determining a negative result. Do not read results after more than 5 minutes.
HOW TO READ THE RESULTS
Negative (not pregnant):
Only one color band appears in the Control Zone. No apparent band in the Test Zone. This indicates that no pregnancy has been detected.
Distinct color bands appear in the Control and Test Zones. This indicates that you are pregnant.
If no band is visible, or there is a visible band only in the test region and not in the control region, the result is invalid. Repeat with a new test kit.
NOTE: If the color in the Test Zone is weak, it is recommended that the test be repeated in 48 hours, or if the test shows negative but you suspect you may still be pregnant, the test may be repeated after a few days.
WHAT TO DO WHEN YOU KNOW THE RESULT
-IF THE RESULT IS POSITIVE (TWO LINES)
Consult your physician. He or she should confirm your pregnancy after evaluating all clinical and laboratory findings. In some rare situations the test may give a false positive result. He or she will also give you further information and advice on your pregnancy.
See also “Understanding test results”.
-IF THE RESULT IS NEGATIVE (ONE LINE)
If you have reasons to believe that you are pregnant (e.g. no menstrual bleeding), you can repeat the test a few days later. If the test is still negative, consult your physician.
See also “Understanding test results”.
UNDERSTANDING TEST RESULTS
1. If a urine sample is too diluted (ie, low specific gravity) it may not contain a representative level of HCG. If pregnancy is still suspected, another urine specimen should be collected 48 hours later and tested.
2. Low concentration of HCG in a very early pregnancy can give a negative result. In this case, another specimen should be obtained at least 48 hours later and tested.
3. Any treatment with HCG may cause false results.
Although the HCG levels in normal early pregnant women are variable, One Step Pregnancy Urine Test is generally capable of detecting pregnancy as early as 1 day after the first missed menses.
One Step HCG Test has a sensitivity of 25 mIU/ml.
The following potentially interfering substances were added to HCG negative and positive specimens and no interference was observed.
Acetaminophen, aspirin, ascorbic acid, atropine, caffeine, glucose, hemoglobin, tetracycline, ampicillin , albumin, bilirubin.
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