The Pregnancy Detection Test is an express pregnancy test that you can easily perform yourself. This test detects the presence of human chorionic gonadotropin (hCG), which appears in the urine at the beginning of pregnancy.

For self-diagnosis in vitro only. For external use only.

HOW DOES IT WORK?

Human Chorionic Gonadotropin (hCG) is a hormone produced by the placenta during its development soon after fertilization and is excreted in the urine. The pregnancy test contains antibodies that specifically react with this hormone.

When the strip is immersed in a urine sample, the sample migrates along the membrane in a capillary fashion. When the hCG in the sample reaches the test section of the membrane, it results in a stained line. A lack of a stained line indicates a negative result.

As a control procedure, a stained line will appear in the control area (C) if the test has been performed correctly.

WHAT ELSE DO YOU NEED?

1. A clean, dry, plastic or glass urine collection container.

2. a timer (clock or chronometer).

PRECAUTIONS

1. this set is for outdoor use only. Do not swallow.

2. Dispose of after the first use. The test strip is for single use only.

Do not use the test kit after the expiration date.

4. Do not use the kit if the bag has holes or is poorly sealed.

5. Keep out of the reach of children.

STORAGE AND STABILITY

Store at 2ºC to 30ºC in a sealed bag until expiration date.

Store in a place protected from direct sunlight, moisture and high temperature.

Do not freeze.

4. It is advisable to open the bag only for a short time before performing the test.

SAMPLE COLLECTION AND PREPARATION

WHEN TO COLLECT URINE FOR THE TEST?

Any urine sample is suitable for a pregnancy test, but a first morning urine sample is optimal given its high concentration of hCG.

HOW TO COLLECT URINE

A urine sample can be collected in any clean, dry, plastic or glass container.

HOW TO PERFORM THE TEST?

1. The test strip and urine must be brought to room temperature (15-30 ° C) to perform the test.

2. Remove the test strip from the sealed package.

3. Immerse the strip in the urine with the arrow pointing in the direction of the urine. Remove the strip after 3 seconds and place it horizontally on a clean, dry, non-absorbent surface (such as the neck of a urine container).

IMPORTANT: Do not allow the urine level to exceed the MAX level (marking line) or the test will not be performed correctly.

4. Positive results can be observed in as little as 1 minute. However, a full reaction time of 3 minutes is required to confirm negative results. Does not read results after more than 5 minutes.

HOW TO READ THE RESULTS?

Negative (not pregnant)

Only one colored band appears in the test section. No band is visualized in the test section. This indicates that no pregnancy is detected.

Positive (pregnant)

Clear colored bands appear in the control and test areas. This indicates that you are pregnant. The intensity of the coloring of the test strips may vary because the hCG hormone concentrations vary at different stages of pregnancy.

Invalid

The strip is not visualized at all, or is only visualized in the test area but not in the control area. Repeat the test with a new test. If the test fails again, contact the distributor or store where you purchased the product with the lot number.

WHAT SHOULD YOU DO WHEN YOU FIND OUT THE RESULT?

If the result is positive (TWO LINES)

Talk to your doctor. He or she must confirm that you are pregnant after evaluating all clinical and laboratory data. Under certain conditions, the test may give a false-positive result. Your doctor will give you more information and advice about your pregnancy.

If the result is negative (ONE LINE)

If you have reason to believe that you are pregnant (e.g. no menstrual bleeding), you can repeat the test after a few days. If the test result is still negative, see your doctor.

LIMITATIONS

1. As with all diagnostic procedures, the final diagnosis of pregnancy can only be confirmed by a physician after evaluation of all clinical and laboratory tests.

2. If the urine sample is too dilute (i.e. has a low relative density), it may not contain sufficient hCG levels. If pregnancy is still suspected, another urine sample should be collected after 48 hours and tested.

A low hCG concentration early in the pregnancy can give a negative result. In this case, collect another sample at least 48 hours later and test it.

4. Elevated hCG levels can be caused by conditions other than pregnancy. Therefore, the presence of hCG in a urine sample should not be used to diagnose pregnancy unless these conditions have been ruled out.

5. A normal pregnancy cannot be distinguished from an ectopic pregnancy by hCG levels alone. In addition, a spontaneous spontaneous miscarriage can cause difficulties in interpreting the test results.

6. Infertility medications based on hCG can cause false results. Consult your physician.

EXPECTED RESULTS

Negative results are expected in healthy non-pregnant women and healthy men. Although hCG levels vary among healthy women in early pregnancy, the pregnancy detection test can detect pregnancy as early as 1 day of menstrual delay.

PERFORMANCE CHARACTERISTICS

Sensitivity

The pregnancy detection test detects hCG in urine at a concentration of 20 mU/mL or higher.

Specificity

The specificity of the pregnancy detection test was determined by cross-reactivity studies with known concentrations of human luteinizing hormone (LH), human follicle stimulating hormone (FSH), and human thyrotropic hormone (TSH). All test results obtained using 300 mMU/ml human LH, 300 mMU/ml human FSH, and 1000 µMO/ml human TTH were negative.

QUESTIONS AND ANSWERS

1. The control lines of the two tests are very different. Is this a problem?

No. Variations in the coloration of the control strip will not affect the test result.

2. Can the test results be interpreted later than five minutes later?

No. The test results should be read immediately after 3 to 5 minutes. Although a positive result will not change for several days, a negative result can change to a false positive within minutes of the end of the test time. It is always best to read the results at the 5 minute mark of the test and then dispose of the test to avoid confusion.

3. During the test, a pink background and vertical streaks appeared in the result area. Is this a problem?

No. Each urine sample will have a different chemical profile, as will the humidity level of the room (room) where the test is performed. Such differences in physical conditions may cause vertical streaks and/or a pale pink background, but will not affect the test results. As long as the control strip appears within five minutes, the test will be performed correctly.