Pregnancy and Fertility Rapid Tests

Procedure

Remove the cap, hold the absorbent tip in the urine stream as directed in the IFU, replace the cap and lay the test flat with the result windows facing upward. Read the result within 1-5 minutes. A control line must appear for the test to be valid.

Practical use tips

• ✓ Check the expiry date and confirm that the foil pouch is sealed and undamaged before use. Do not use a test from an opened, torn or moisture-damaged pouch.
• ✓ Allow a refrigerated test to reach room temperature before opening the pouch. Open the pouch only when ready to test and use the device immediately.
• ✓ Do not touch the absorbent tip or result window. After sampling, replace the cap and place the device on a clean, flat, dry surface with the result window facing upward.
• ✓ Use the exposure time stated in the product IFU. Insufficient wetting, excessive immersion or urine entering the result window may cause an invalid result.
• ✓ Read the result only within the stated 1-5 minute window. Changes appearing after 5 minutes must not be interpreted.
• ✓ The control line confirms that the test has run correctly. If no control line appears, discard the device and repeat the test with a new one.
• ✓ For the best chance of detecting a very early pregnancy, use first-morning urine and avoid excessive fluid intake immediately before testing.
• ✓ The device is for single use only. Do not reuse, disassemble or compare line darkness as a quantitative measurement of hCG concentration.

Important precautions and limitations

• ! A negative result may occur when testing is performed too early or the urine is dilute. If pregnancy is still suspected, use first-morning urine and repeat after 24-48 hours.
• ! hCG may remain detectable after delivery or abortion and may also be associated with certain medical conditions.
• ! Very high hCG concentrations above 500,000 mIU/mL may cause a prozone effect and a false-negative result; follow the IFU's dilution and retest instruction.
• ! A positive result indicates that hCG has been detected; it does not by itself confirm the location or normal progression of a pregnancy.
• ! An unexpected positive, repeated negative or invalid result should be reviewed using a new specimen and, when appropriate, a healthcare professional's assessment.
• ! A test result should not replace clinical evaluation when symptoms or medical history require professional assessment.