Pregnancy test - disposable test for self-testing

Product Description

Pregnancy Test

Indications

Pregnancy Test by Sofarmapiù is a rapid immunochromatographic test for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. The test uses a combination of antibodies, including the hCG monoclonal antibody, to selectively detect elevated levels of hCG. The test is performed by pouring urine onto the hydrophilic dipstick and interpreting the result based on the colored lines that appear.

Directions for use

Sample collection and preparation

The urine sample must be collected in a clean, dry container. A sample from the first morning urine is preferable, since it is not suitable for early pregnancy. Urine samples generally contain the highest concentration of hCG. However, urine samples collected at any time of day can be used. Urine samples containing visible particles should be centrifuged, filtered, or allowed to settle to obtain a clear sample for testing. If testing is not possible immediately, urine samples can be stored at 2-8°C for up to 48 hours before testing. For extended storage, samples can be frozen and stored at temperatures below -20°C. Frozen samples must be thawed and mixed before testing.

Testing Procedure

Allow the test and sample to reach room temperature (15-30°C) before testing. Remove the test stick from the foil pouch and use it within one hour. Remove the test stick cap. Hold the stick by the handle, placing the absorbent end under your urine stream or immersing it (≥2/3) in urine collected in a clean container for at least 15 seconds. Do not urinate in the result window. Cover the stick with the cap and leave it on a clean, flat surface. Start the timer immediately. Read the result after 3 minutes; do not interpret it after 10 minutes.

Reading the results

• Positive: Two colored lines appear, the control line (C) and the test line (T). One line may be lighter than the other; they do not have to be the same. This indicates that you are probably pregnant.
• Negative: The control line (C) appears. The test line (T) does not appear. This indicates that you are probably not pregnant.
• Invalid: The control line does not appear, so the result is invalid even if the test line (T) appears. Repeat the test with a new test stick.

Warnings

For in vitro diagnostic use. For external use only. Before performing the test, read all the information in the package insert. Keep out of reach of children. Do not use if the pouch is torn or damaged. Do not open the test stick until you are ready to start the test. The used test stick must be disposed of according to local regulations. Do not use after the expiration date printed on the foil pouch. The test may produce incorrect results. Consult your doctor before making any medical decisions. Medications that contain hCG (such as Pregnyl, Profasi, Pergonal, APL) may produce false-positive results. Alcohol, oral contraceptives, painkillers, or hormone therapies that do not contain hCG should not interfere with results. Very dilute urine samples, characterized by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a new first-morning urine sample should be collected and tested 48 hours later. Immediately after fertilization, hCG levels in urine samples are very low (less than 50 mIU/mL). However, because a significant number of first-trimester pregnancies end naturally, a weakly positive result should be confirmed with a second test performed on a first-morning urine sample collected 48 hours later. This test may produce false-positive results. A number of conditions other than pregnancy, including trophoblastic disease and some non-trophoblastic malignancies, including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated hCG levels. Therefore, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions are excluded. The test may produce false-negative results. False-negative results may occur when hCG levels are lower than the sensitivity level of the test. If pregnancy is still suspected, a new first-morning urine sample should be collected and tested 48 hours later. If pregnancy is suspected but the test continues to produce negative results, consult a doctor for further diagnosis. The test provides a presumptive diagnosis of pregnancy. A confirmatory diagnosis should be made only by a doctor after evaluation of all clinical laboratory tests.

Storage

Store in its original packaging at room temperature or in the refrigerator (2-30°C). Do not freeze. Shelf life: 24 months.

Format

The kit contains: test stick and package leaflet.