The X-Epil Digital Pregnancy Test Pen is an in vitro diagnostic (IVD) medical device intended for self-testing. It is designed to detect human chorionic gonadotropin (hCG) in urine at concentrations of 25 mlU/ml or higher.

The digital display provides a clear test result by indicating either "Pregnant" or "Not Pregnant".

Intended Use

The X-Epil Digital Pregnancy Test Pen is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for self-testing by lay users.

Package Contents

• 1 × X-Epil Digital Pregnancy Test Pen
• 1 × Instructions for Use

Please read the Instructions for Use carefully before performing the test.

Before Testing

• Allow the test device and the urine sample to reach room temperature (15–30°C) before use.
• For best results, the first morning urine is recommended, as it generally contains the highest concentration of hCG. The test may also be used with urine collected at any time of the day.
• Do not hold the test with the absorbent tip pointing upward during testing.

Test Procedure

Direct Sampling

1. Remove the test device from the foil pouch and remove the protective cap.
2. Hold the device by the handle with the absorbent tip pointing downward.
3. Place the absorbent tip in the urine stream for 5 seconds, ensuring that urine does not come into contact with the plastic housing.

Sample Collection Method

1. Collect urine in a clean, dry container.
2. Immerse the entire absorbent tip in the urine sample for 10 seconds.

After sample collection:

1. Replace the protective cap.
2. Place the test on a clean, flat surface with the display facing upward.
3. A flashing hourglass symbol indicates that the test is processing.
4. Read the result after approximately 3 minutes.
5. The display will show either "Pregnant" or "Not Pregnant". The result remains visible for approximately 1 hour.

READ THE INSTRUCTIONS FOR USE FOR POTENTIAL RISKS, OR ASK YOUR DOCTOR!

Frequently Asked Questions

1. How accurate is the Digital Pregnancy Test?

A clinical evaluation involving 150 urine specimens tested by healthcare professionals compared the results of the Digital Pregnancy Test with those of another commercially available urine hCG test. The overall accuracy was >99%.

An additional clinical evaluation involving 100 urine specimens tested by lay users compared the results of the Digital Pregnancy Test with those of another commercially available ECLIA hCG test. The overall accuracy was >99%.

2. How does the test work?

The test detects the pregnancy hormone hCG (human chorionic gonadotropin) in urine. During pregnancy, the body produces hCG, and its concentration increases during the early stages of pregnancy. The Digital Pregnancy Test can detect hCG in urine at concentrations as low as 25 mlU/ml.

3. Do I have to use my first morning urine?

The test can be used at any time of the day. However, first morning urine is typically the most concentrated and may provide more accurate results.

4. What should I do if the result shows "Pregnant"?

You may be pregnant. Please consult your healthcare professional to confirm the result and receive appropriate medical advice.

5. What should I do if the result shows "Not Pregnant"?

You may not be pregnant, or your hCG level may not yet be high enough to be detected. If your menstrual period does not begin within one week of the expected date, repeat the test using a new test. If the repeat test also shows "Not Pregnant" and your period is still delayed, consult your healthcare professional.

6. A "?" symbol is displayed on the screen. What does it mean?

The "?" symbol indicates that an error occurred during testing. Please read the instructions carefully and repeat the test using a new device. Refer to the "Test Errors" section.

7. I used the test, but no result appeared on the display. What does this mean?

If no result appears on the display, please refer to the "Test Errors" section.