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 hCG monoclonal antibody, 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.

Instructions for use
Sample collection and preparation
The urine sample should be collected in a clean, dry container.
A first morning urine sample is preferable, as they generally contain the highest concentration of hCG. However, it is possible to use urine samples collected at any time of the day.
Urine specimens with visible particles should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for analysis.
If testing is not possible immediately, urine samples can be stored at 2-8°C for up to 48 hours before testing. In case of prolonged storage, samples can be frozen and stored at temperatures below -20°C. Frozen samples must be thawed and mixed before analysis.

Testing procedure
Before testing, allow the test and sample to reach room temperature (15-30°C).
Remove the stick from the foil pouch and use it within an hour. Remove the stick cap.
Hold the stik by the handle, placing the absorbent end under the urine stream or immersing it (≥2/3) in the urine collected in a clean container for at least 15 seconds. Do not urinate in the results 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 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: 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, the result is therefore to be considered invalid even if the test line (T) appears. Repeat the test with a new stick.

Warnings
For in vitro diagnostic use.
For external use only.
Before carrying out the test, read all the information contained in the information leaflet.
Keep out of reach of children.
Do not use if pouch is torn or damaged.
Do not open the test stick until you are ready to begin the test.
The used stick must be disposed of in accordance with local regulations.
Do not use after the expiry date printed on the foil pouch.
The test may produce incorrect results. Consult your doctor before making any medical decisions.
Drugs that contain hCG (such as Pregnyl, Profasi, Pergonal, APL) may produce false positive results. Alcohol, oral contraceptives, pain relievers, or hormone therapies that do not contain hCG should not interfere with your results.
Very dilute urine samples, characterized by low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a new sample of the matti's urine will need to be collected and tested