easy home Pregnancy Test Strip User Manual

easy home Pregnancy Test Strip

• Please read all the information in this user manual before performing the test. easy@Home Pregnancy (HCG) Test Strip is an in vitro diagnostic home-use test device intended for the rapid determination of human chorionic gonadotropin (CG) in urine to aid in the early detection of pregnancy. You can easily carry out yourself.
• It is intended for over-the-counter (OTC) use.
• For in vitro diagnostic home use only.

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 is dipped in the urine specimen, the urine specimen is applied to the strip and migrates along the strip. When CG in the sample reaches the Test Zone region of the membrane, it will form 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.

CONTENTS OF THE TEST KIT

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

WHAT ELSE DO YOU NEED?
A clean, dry, plastic or glass container to collect the urine. Timer or clock.
PRECAUTIONS

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

STORAGE AND STABILITY

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

WHEN TO COLLECT URINE FOR THE TEST?
For many women, HG 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.

HOW TO COLLECT THE URINE SAMPLE?
Urine specimens may be collected in any clean, dry, plastic, or glass container.
HOW TO PERFORM THE TEST?

1. The test strip and urine have to be at room temperature 59-86°F (15-30°C) for testing.

2. Remove the test strip from the sealed pouch.

3. 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.

4. Read results in five minutes. Positive results may sometimes appear as early as one minute but you should wait the full 5 minutes before determining a negative result. Do not read results after more than 5 minutes. 5

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 there is a visible band only in the test region and not in the control region. Repeat with a new test kit.

NOTE: if the color in the Test Zone is weak, it is recommended iS that the test be repeated in 48 hours, or if the test shows negative but you suspect you may still be pregnant, the test may be repeated after a few days.

WHAT TO DO WHEN YOU KNOW THE RESULT?

IF THE RESULT IS POSITIVE (TWO LINES)

• Consult your physician. He or she should confirm your pregnancy after evaluating all clinical and laboratory findings. In some rare situations, the test may give a false positive result. He or she will also give you further information and advice on your pregnancy. See also “Understanding test results”.

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.
• See also “Understanding test results”.

UNDERSTANDING TEST RESULTS

1. If a urine sample is too dilute (ie, low specific gravity) it may not contain a representative level of CG. If pregnancy is still suspected, another urine specimen should be collected 48 hours later and tested.
2. 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.
3. Any treatment with hCG may cause false results.

EXPECTED RESULTS

Although the hG levels in normal early pregnant women are variable, 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. There is much difference between the control lines of the 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 in 5 minutes. A negative result may change to a false positive within minutes after the end of 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.

• If you have any questions, please call us toll-free at 1-855-822-6999 (Monday-Friday 9:00 a.m. – 5:00 p.m.
• Central Time). Our professional staff will be happy to assist you.
• To learn more, please visit us at www.premom.com

STABILITY

• Real-time studies have been conducted by 3 lots of the corresponding easy@Home Pregnancy (HCG) Test Strip. The results demonstrate that the easy@Home Pregnancy (HCG) Test Strip unopened (shelf-life) stability is 36 months at 39 ~ 86 °F (4~30° C).
• MANUFACTURED FOR Easy Healthcare Corporation
• 360 Shore Dr. Unit B, Burr Ridge, IL USA 60527
• Made in China

MEANING OF SYMBOLS ON PACKAGE

• Keep away from sunlight
• Store between 39°F and 86°F
• Keep dry
• Do not re-use
• www.premom.com
• Questions or comments?
• Please call toll-free:
• 1-855-822-6999 M-F9 a.m.-5 p.m. CST
• E-mail:service@healthcare-manager.com
• Easy Healthcare Corporation 360 Shore Dr. Burr Ridge, IL USA 60527

Documents / Resources

| easy home Pregnancy Test Strip [pdf] User Manual
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