Pregnancy (HCG) Test Strip User Manual

How Does It Work?

Human chorionic gonadotropin (hCG) is a hormone produced by the developing placenta and secreted into the urine. The pregnancy test contains antibodies that specifically react with this hormone. When the sample end of the test strip is dipped in a urine specimen, the urine is applied to the strip and migrates along it. When hCG in the sample reaches the Test Zone region of the membrane, it forms a colored line. The absence of this colored line suggests a negative result. A colored line will appear at the Control Zone region if the test has been performed properly.

The test strip has distinct zones: a 'SAMPLE END' for dipping into urine, a 'TEST ZONE' where the hCG reaction occurs, and a 'CONTROL ZONE' where a control line appears to indicate the test is working correctly. A 'MAXIMUM LEVEL LINE' (marker line) indicates the maximum urine level for proper testing.

Contents of the Test Kit

• One pouch containing a reaction strip and a desiccant. The desiccant is for storage purposes only and is not used in the test procedures.
• Leaflet with instructions for use.

When to Collect Urine for the Test?

For many women, hCG may be detectable with this test by the day after the missed period. Any urine specimen is appropriate for pregnancy testing, but the first morning urine specimen is optimal because of its highest concentration of hCG.

What Else Do You Need?

• A clean, dry, plastic or glass container to collect the urine.
• Timer or clock.

Precautions

• This kit is for external use only. Do not swallow.
• Discard after first use. The test strip cannot be used more than once.
• Do not use the test past the expiration date printed on the foil pouch.
• Do not use the kit if the pouch is punctured or not well sealed.
• Keep out of the reach of children.

Storage and Stability

• Store at 39°F to 86°F (4°C to 30°C) in the sealed pouch up to the expiration date.
• Keep away from direct sunlight, moisture, and heat.
• DO NOT FREEZE.
• Perform the test soon after opening the pouch. Keep the test in a dry environment before use.

How to Collect the Urine Sample?

Urine specimens may be collected in any clean, dry, plastic or glass container.

How to Perform the Test?

• Ensure the test strip and urine are at room temperature (59-86°F / 15-30°C) for testing.
• Remove the test strip from the sealed pouch.
• Immerse the strip into the urine with the arrow pointing towards the urine. Take the strip out after 5 seconds and lay the strip flat on a clean, dry, non-absorbent surface (such as the mouth of the urine container).
• Important: Do not allow the urine level to exceed the MAX marker line, otherwise the test will not perform correctly.
• Read results in five minutes. Positive results may appear as early as one minute, but wait the full 5 minutes for a negative result. Do not read results after more than 5 minutes.

How to Read the Results?

Negative (not pregnant): Only one color band appears in the Control Zone. No apparent band on the Test Zone. This indicates that no pregnancy has been detected.

Positive (pregnant): Distinct color bands appear in the Control and Test Zones. It indicates that you are pregnant.

Invalid: No visible band at all, or a visible band only in the test region and not in the control region. Repeat with a new test kit.

The document illustrates results with labels 'C' for Control line and 'T' for Test line. A positive result shows bands at both C and T. A negative result shows a band only at C. An invalid result shows no band at C, or a band only at T.

Note

If the color in the Test Zone is weak, it is recommended to repeat the test in 48 hours. If the test shows negative but pregnancy is still suspected, the test may be repeated after a few days.

Expected Results

Although hCG levels vary in normal early pregnant women, the easy@Home Pregnancy (HCG) Test Strip is generally capable of detecting pregnancy as early as 1 day after the first missed menses.

Questions & Answers

1. Is there a big difference between the control lines of two tests? Is this a concern?
No. Variations in the color of the control band will not affect the test result.

2. Can test results be interpreted after more than five minutes?
No. Test results must be read within 5 minutes. A negative result may change to a false positive within minutes after the testing period, which would not be an accurate reading. It is always best to read the results at the 5-minute testing period and then discard the test to avoid confusion.

What to Do When You Know the Result?

If the Result is Positive (Two Lines): Consult your physician. They should confirm your pregnancy after evaluating all clinical and laboratory findings. In some rare situations, the test may give a false positive result. They will also provide further information and advice on your pregnancy.

If the Result is Negative (One Line): If you have reasons to believe that you are pregnant (e.g., no menstrual bleeding), you can repeat the test a few days later. If the test is still negative, consult your physician.

Understanding Test Results

• If a urine sample is too dilute (i.e., low specific gravity), it may not contain a representative level of hCG. If pregnancy is still suspected, another urine specimen should be collected 48 hours later and tested.
• Low concentration of hCG in a very early pregnancy can give a negative result. In this case, another specimen should be obtained at least 48 hours later and tested.
• Any treatment with hCG may cause false results.

Contact Information

• For questions or comments, please call toll-free at 1-855-822-6999 (Monday-Friday 9:00 a.m. - 5:00 p.m. Central Time).
• Email: service@healthcare-manager.com
• Manufacturer: Easy Healthcare Corporation, 360 Shore Dr., Burr Ridge, IL USA 60527
• To learn more, please visit: www.premom.com

Meaning of Symbols on Package

• [Sun symbol] Keep away from sunlight
• [Thermometer symbol] Store between 39°F and 86°F (4°C to 30°C)
• [Droplet symbol] Keep dry
• [Recycle symbol] Do not re-use