FIRST RESPONSE Gold® Digital Pregnancy Test
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Instructions and Use
When to Use the FIRST RESPONSE Gold® Digital Pregnancy Test
Instructions
Reading Your Results
Questions and Answers


PLEASE READ ALL THE INFORMATION IN THIS
LEAFLET BEFORE PERFORMING THE TEST.

  • Do not use after the expiration date stamped on the side of the carton.
  • Store in a dry place below 86°F (30°C). Do not freeze.
  • Keep out of reach of children.
  • For in-vitro diagnostic use. Not to be taken internally.
  • Single-use device. Do not reuse.


If you have any questions please call us toll-free at 1-800-367-6022, Monday-Friday from 7:00AM to 5:00PM Eastern Time.
Visit us online at www.TellsYouFirst.com.



The FIRST RESPONSE GOLD® Digital Pregnancy Test is so sensitive it can detect hCG (human chorionic gonadotropin) as early as 4 days before your expected period. You can use the FIRST RESPONSE® test at any time of day or night, and while you do not have to use first-morning urine, in general, your first-morning urine contains the highest level of pregnancy hormone.



THIS DEVICE SELF-ACTIVATES UPON REMOVAL FROM THE WRAPPER. DO NOT OPEN WRAPPER UNTIL YOU ARE READY TO USE.

• After reading the insert when you are ready to perform the test remove the test stick from the foil wrapper and remove the Overcap. (Upon removal from the wrapper, check the Display Screen for the presence of a steady clock symbol . The device is ready for use. Do not use the test unless the steady clock symbol is on the Display Screen.)


STEP 1


  • Hold Thumb Grip so that the Absorbent Tip is pointing downward and the Display Screen is facing away from your body.
  • Place the Absorbent Tip in your urine stream for 5 seconds. Be careful not to get the urine on the plastic holder. During testing, never hold the device with the Absorbent Tip pointing upward.
  • You may collect your urine in a clean, dry cup and immerse the entire Absorbent Tip in the urine for 5 seconds.


STEP 2


  • While still holding the stick with the Absorbent Tip facing downward, replace the Overcap and lay the stick on a flat non-absorbent surface with the Display Screen facing up.
  • The clock symbol will begin to blink in about 30 seconds after urine is applied to indicate the test is working.

STEP 3

  • In approximately 3 minutes, an unmistakable "YES+" or "NO-" will appear on the Display Screen.


Q: How does the test work?
 A: The FIRST RESPONSE GOLD® Digital Pregnancy Test detects human chorionic gonadotropin (hCG), the hormone your body produces during pregnancy. The FIRST RESPONSE® test is so sensitive that it can detect hCG as early as 4 days before your expected period. The amount of pregnancy hormone increases as pregnancy progresses. In clinical testing, FIRST RESPONSE® detected the hormone levels in 58% of women 4 days before their expected period, in 80% of women 3 days before their expected period, in 90% of women 2 days before their expected period, and in 94% of women 1 day before their expected period.

Q: How accurate is the test?
 A: In laboratory studies of the FIRST RESPONSE GOLD® Digital Pregnancy Test with urine samples from pregnant and non-pregnant women, the accuracy was greater than 99% accurate. **
** However, some pregnant women may not have detectable amounts of pregnancy hormone in their urine on the first day of their missed period or may have miscalculated the first day of their period. In a study of pre-, peri-, and post-menopausal aged, non-pregnant women, about 0.2% of the women (over age 47) had very low levels of hCG that gave positive test results. If you are in this category of women and get a positive result, you should have your result confirmed by your doctor.

Q: What do I do if the result on the Display Screen is "YES+" (pregnant)?
 A: A "YES+" test result shows that the pregnancy hormone (hCG) was detected, which normally indicates pregnancy. You must see your doctor to confirm that you are pregnant.

Q: What do I do if the result on the Display Screen is "NO-" (not pregnant)?
 A: You may not be pregnant, or it may be too early to tell. If you do not get your period within 7 days, you should retest with another FIRST RESPONSE GOLD® Digital Pregnancy Test. It is possible that you miscalculated the length of your cycle or your urine may not have had enough pregnancy hormone for the test to register a "YES+" result. If upon retesting you get another "NO-" result and your period has still not started, you should call your doctor.

Q: The blinking clock has disappeared followed by a "?" on the Display Screen. What does this mean?
 A: A "?" symbol indicates an error has occurred during testing. You should retest with another FIRST RESPONSE GOLD® Digital Pregnancy Test, carefully following all directions.

Q: The Display Screen is blank. What is wrong?
 A: If the display screen goes blank at any time before yielding a result, an error has occurred. You should retest with another FIRST RESPONSE® Digital Pregnancy Test, carefully following all directions.

Q: How long will my result show on the Display Screen?
 A: Your result will be displayed for at least 30 minutes. Read your results within this time frame. Once you have read your result, discard the stick.
Note: This device contains a battery with a removal feature on the reverse side of the Thumb Grip. Be sure to dispose of the battery according to local regulations.

Q: What will happen if the plastic holder gets wet?
 A: Some splashing while using the test will not damage the test, but if it becomes very wet it can become damaged. If the test becomes damaged, the Display Screen will either go blank or an error "?" message will appear.

Q: Do any drugs or medications affect the test?
 A: Only medications containing the pregnancy hormone (hCG) can affect the result (for example, A.P.L.1, Pregnyl2, Profasi3 and Pergonal3). The test should not be affected by hormone therapies containing Clomiphene citrate (for example Clomid4 and Serophene5), alcohol, antibiotics or the contraceptive pill.

Q: I removed the device from the wrapper and the clock symbol appeared on the Display Screen; however, I'm not ready to use the test. What should I do?
 A: Once removed from the wrapper, the device must be used within 12 hours. Keep the device dry before use.

If you have any questions, call us toll-free at 1-800-367-6022, Monday-Friday from 7:00AM to 5:00PM Eastern Time. Visit us online at www.TellsYouFirst.com.

To increase your chances for a healthy pregnancy for you and your baby, you should consider the following:
  • Maintain a healthy diet.
  • Stop smoking.
The period from conception through the third month of pregnancy is a very important time. You should see your doctor regularly throughout your pregnancy for proper care and nutritional counseling.

WARNING: According to the Surgeon General, women should not drink alcoholic beverages during pregnancy due to the risk of birth defects.

Understanding Your Ability to Get Pregnant
FSH (follicle stimulating hormone) is one of the leading single indicators of a women’s fertility potential. The FIRST RESPONSE® Fertility Test for Women is an accurate test of FSH level to assess ovarian reserve (egg quantity and quality). Using the test on day 3 of your menstrual cycle can help you determine your ability to get pregnant.

Trying to get pregnant...
Many women do not know that their most fertile days are the days leading up to ovulation (when your ovary releases an egg to be fertilized by the sperm). To become pregnant sooner, you should become more familiar with your ovulation cycle. The FIRST RESPONSE® Ovulation Test kit is an at-home, one-step test designed to predict ovulation by monitoring changes in your hormone levels. With the help of the FIRST RESPONSE® Ovulation Test kit, you can pinpoint your peak fertility days and get pregnant sooner.




Distributed by Church & Dwight Co., Inc. Princeton NJ 08543
FIRST RESPONSE is a registered trademark of Church & Dwight Co., Inc.


    1 A.P.L is a registered trademark of Wyeth-Ayerst Laboratories Division of American Home Products Corp.
    2 Pregnyl is a registered trademark of Organon, Inc.
    3 Profasi and Pergonal are registered trademarks of Ares Trading SA.
    4 Clomid is a registered trademark of Merrell Pharmaceutical.
    5 Serophene is a registered trademark of Serono Laboratories, Inc.