Xy

Pregnancy test

CE medical device.

Principle
The Early Pregnancy Test is a rapid, single-step lateral flow immunochromatographic stick test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the purpose of diagnosing pregnancy. The test uses a combination of antibodies, including anti-hCG monoclonal antibody, to selectively detect elevated hCG levels. The test is performed by dipping the absorbent end of the stick directly into the urine stream or into the urine collected in a container. The results are determined by the appearance of colored lines.

Indications for performing the test
1. Open the sealed package, take out the stick (pen) and take a careful look at the product.
2. Remove the colored cap to reveal the absorbent end and place it over the handle.
3. Hold the stick by the handle, placing the absorbent tip directly under the urine stream for at least 10 seconds, until completely humidified. Be careful not to get the transparent windows of the T Test Result and Control C Results. You can optionally collect the urine in a clean, dry container, then dip the absorbent tip of the stick into the urine for at least 10 seconds.
4. After removing the stick from the urine, immediately reinsert the colored cap on the absorbent tip and place the stick on a flat surface with the T and C windows facing up. Start the time count.
5. As the test begins to react, a pink flow can be observed moving through the clear windows T and C.
Wait 3 minutes to read the result.
If no colored line appears, wait another 1 minute. In some cases, positive results may be seen after approximately 1 minute, depending on the hCG concentration. Do not read the results beyond 10 minutes.

Reading the results
Pregnancy: Two distinct lines appear. One line in control window C and another in test result window T. One line may be lighter than the other, it doesn't matter, they don't necessarily have to be the same. The presence of the two lines indicates that you are most likely pregnant.
Non-Pregnancy: A colored line appears in the control window C. No lines appear in the test result window T. This indicates that you are most likely not pregnant.
Invalid: The test result is considered valid if no line appears in the control window C. Even if a line appears in the result window of the T test the result is considered invalid. The test must be repeated with another stick.

Limits
The test may produce incorrect results. Consult your physician before making any medical decisions.
1. Medicines that contain hCG (such as Pregnyl, Profasi, Pergonal, APL) can produce false pregnancy results. Alcohol, oral contraceptives, pain relievers, antibiotics, and hormone therapies that do not contain hCG should not interfere with the results.
2. Certain medical conditions, other than pregnancy, including ovarian cyst or extra uterine pregnancy, can cause hCG levels to rise, giving a false pregnancy result.

Format
Pack of 1 test stick.