Description
DERMAcotton
Description
Self-test for pregnancy.
The Rapid Pregnancy Test is a one-step rapid test for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early diagnosis of pregnancy. The test is intended for in vitro self-diagnosis.
Human chorionic gonadotropin (hCG) is a hormone produced by the placenta shortly after conception and secreted into the urine. The pregnancy test contains antibodies that react specifically with this hormone. When the urine sample comes into contact with the absorbent tip of the test, capillary action moves the sample along the membrane. When the hCG in the sample reaches the test zone of the membrane, a colored line will form. The absence of this colored line suggests a negative result. As a check, a colored line will appear in the control zone if the test was performed correctly.
How to use
Allow the test cassette and urine specimens to equilibrate to room temperature (20-30°C) before performing the test.
1. Remove the test stick from the foil pouch by tearing the notch and remove the cap from the test stick.
2. To perform the test, rotate the stick so that the absorbent tip is facing down and hold the stick in your urine stream so that urine contacts the absorbent area.
Place it for at least ten seconds so that urine enters sufficiently into the absorbent part of the tip. Do not let urine splash into the result window.
3. Close the pregnancy test stick and place it on a horizontal surface with the result window facing upwards.
4. Wait for red lines to appear. The test should be read in approximately 3-5 minutes. Do not interpret results after the specified reaction time.
Reading the results
Positive: Two distinct red lines will appear, one in the test region (T) and one in the control region (C). Positive test results are possible, but not definitive for the diagnosis of pregnancy. It is strongly recommended that you obtain an additional urine sample after 48-72 hours and retest, or consult your doctor.
Negative: A single red line appears in the control region (C). No apparent red or pink line appears in the test region (T). Negative test results mean you are not pregnant, but you should repeat the test with the first morning sample obtained 48-72 hours later.
Invalid: The control band does not appear, which probably means incorrect testing procedures or reagent deterioration. In any case, repeat the test. If the problem persists, immediately discontinue use of the lot and contact your local distributor.
Warnings
1. For in vitro diagnostic use only.
2. Do not use after expiration date.
3. The test strip must remain in the sealed pouch until use. Do not use if the pouch is damaged or opened.
4. Read the instructions for use carefully before performing the test. Avoid contact of the skin, eyes or clothing with the test area.
5. As with all diagnostic tests, a confirmed pregnancy diagnosis should be made by a physician only after evaluating all clinical and laboratory findings.
6. Do not reuse the test strip. Discard it after one use.
7. All urine specimens and the used strip should be considered potentially infectious and avoid contact with skin.
8. Follow local regulations for disposing of used tests.
9. For external use only, do not swallow.
Limitations
1. As with any diagnostic procedure, a confirmed pregnancy diagnosis should only be made by a physician after evaluating all clinical and laboratory findings.
2. If a urine sample is too dilute (i.e., low specific gravity) it may not contain a representative level of hCG. If pregnancy is still suspected, another urine sample should be collected 48 hours later and tested.
3. A low concentration of hCG in a very early pregnancy can give a negative result. In this case, it is necessary to collect another sample at least 48 hours later and analyze it.
4. High levels of hCG can be caused by some 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 based on hCG levels alone. Additionally, miscarriage can cause confusion in interpreting test results.
6. Infertility treatments based on hCG may cause incorrect results. Consult your doctor for further diagnosis.
7. This test is a qualitative screening test. It is not designed to determine the quantitative concentration of hCG.
8. The device is only suitable for testing human urine.
9. Dirty samples or pollutants in urine may cause false results.
10. An unclean test device or incorrect operation may cause false results.
Conservation
Store the kit as packaged in the sealed pouch at room temperature (4-30°C).
The kit is stable until the expiration date shown on the label.
Once the pouch is opened, the test strip must be used within one hour. Prolonged exposure to environmental humidity causes the product to deteriorate.
Do not freeze. Keep away from direct sunlight, moisture and heat.
Do not reuse.
Preferably open the bag only shortly before carrying out the test.
Code 221
Self-test for pregnancy.
The Rapid Pregnancy Test is a one-step rapid test for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early diagnosis of pregnancy. The test is intended for in vitro self-diagnosis.
Human chorionic gonadotropin (hCG) is a hormone produced by the placenta shortly after conception and secreted into the urine. The pregnancy test contains antibodies that react specifically with this hormone. When the urine sample comes into contact with the absorbent tip of the test, capillary action moves the sample along the membrane. When the hCG in the sample reaches the test zone of the membrane, a colored line will form. The absence of this colored line suggests a negative result. As a check, a colored line will appear in the control zone if the test was performed correctly.
How to use
Allow the test cassette and urine specimens to equilibrate to room temperature (20-30°C) before performing the test.
1. Remove the test stick from the foil pouch by tearing the notch and remove the cap from the test stick.
2. To perform the test, rotate the stick so that the absorbent tip is facing down and hold the stick in your urine stream so that urine contacts the absorbent area.
Place it for at least ten seconds so that urine enters sufficiently into the absorbent part of the tip. Do not let urine splash into the result window.
3. Close the pregnancy test stick and place it on a horizontal surface with the result window facing upwards.
4. Wait for red lines to appear. The test should be read in approximately 3-5 minutes. Do not interpret results after the specified reaction time.
Reading the results
Positive: Two distinct red lines will appear, one in the test region (T) and one in the control region (C). Positive test results are possible, but not definitive for the diagnosis of pregnancy. It is strongly recommended that you obtain an additional urine sample after 48-72 hours and retest, or consult your doctor.
Negative: A single red line appears in the control region (C). No apparent red or pink line appears in the test region (T). Negative test results mean you are not pregnant, but you should repeat the test with the first morning sample obtained 48-72 hours later.
Invalid: The control band does not appear, which probably means incorrect testing procedures or reagent deterioration. In any case, repeat the test. If the problem persists, immediately discontinue use of the lot and contact your local distributor.
Warnings
1. For in vitro diagnostic use only.
2. Do not use after expiration date.
3. The test strip must remain in the sealed pouch until use. Do not use if the pouch is damaged or opened.
4. Read the instructions for use carefully before performing the test. Avoid contact of the skin, eyes or clothing with the test area.
5. As with all diagnostic tests, a confirmed pregnancy diagnosis should be made by a physician only after evaluating all clinical and laboratory findings.
6. Do not reuse the test strip. Discard it after one use.
7. All urine specimens and the used strip should be considered potentially infectious and avoid contact with skin.
8. Follow local regulations for disposing of used tests.
9. For external use only, do not swallow.
Limitations
1. As with any diagnostic procedure, a confirmed pregnancy diagnosis should only be made by a physician after evaluating all clinical and laboratory findings.
2. If a urine sample is too dilute (i.e., low specific gravity) it may not contain a representative level of hCG. If pregnancy is still suspected, another urine sample should be collected 48 hours later and tested.
3. A low concentration of hCG in a very early pregnancy can give a negative result. In this case, it is necessary to collect another sample at least 48 hours later and analyze it.
4. High levels of hCG can be caused by some 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 based on hCG levels alone. Additionally, miscarriage can cause confusion in interpreting test results.
6. Infertility treatments based on hCG may cause incorrect results. Consult your doctor for further diagnosis.
7. This test is a qualitative screening test. It is not designed to determine the quantitative concentration of hCG.
8. The device is only suitable for testing human urine.
9. Dirty samples or pollutants in urine may cause false results.
10. An unclean test device or incorrect operation may cause false results.
Conservation
Store the kit as packaged in the sealed pouch at room temperature (4-30°C).
The kit is stable until the expiration date shown on the label.
Once the pouch is opened, the test strip must be used within one hour. Prolonged exposure to environmental humidity causes the product to deteriorate.
Do not freeze. Keep away from direct sunlight, moisture and heat.
Do not reuse.
Preferably open the bag only shortly before carrying out the test.
Code 221
