SOFARMAPIU' SELF-DIAGNOSTIC PREGNANCY TEST

Description
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 monoclonal antibody hCG, to selectively detect elevated levels of hCG.
The test is performed by pouring urine onto the hydrophilic stick and interpreting the result based on the colored lines that appear.

How to use
Sample collection and preparation
The urine sample must be collected in a clean, dry container.
A first-morning urine sample is preferable, as it generally contains 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 analysis.
If testing is not possible immediately, urine samples can be stored at 2-8°C for up to 48 hours before analysis. For extended storage, samples can be frozen and stored at temperatures below -20°C. Frozen samples must be thawed and mixed before analysis.

Test procedure
Before proceeding with the analysis, allow the test and the sample to reach room temperature (15-30°C).
Remove the test stick from the foil pouch and use it within one hour. Remove the cap from the test stick.
Hold the stick by the handle, placing the absorbent end under the 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, then leave it on a flat, clean surface.
Start the timer immediately. Read the result after 3 minutes; do not interpret it after 10 minutes.

Interpretation of 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 necessarily 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, therefore the result is to be considered 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 pouch is torn or damaged.
Do not open the stick until you are ready to start testing.
The used stick must be disposed of in accordance with 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 containing 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 the 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 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 have been ruled out.
The test may produce false-negative results. False-negative results can occur when hCG levels are below the sensitivity of the test. If pregnancy is still suspected, a new morning urine sample will need to 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 physician after evaluating all clinical laboratory tests.

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

Format
The kit contains:
- stick test;
- package leaflet.

Cod. SF003