Sensitive enough to give you results 6 days before your missed period (5 days before the day of your expected period)2, our FIRST RESPONSE™ Digital Pregnancy Test also offers easy to read Yes+ / No- results. The unique ‘test is working’ indicator lets you know the test is ready for use.
ALWAYS READ THE LABEL. FOLLOW DIRECTIONS FOR USE.
The FIRST RESPONSE™ Digital Pregnancy Test detects in urine the hormone your body produces during pregnancy; human chorionic gonadotropin (hCG)2
It is important to follow the instructions in the product leaflet. With the FIRST RESPONSE™ Digital Pregnancy Test you hold the test in the stream of urine for 5 seconds ONLY. It is recommended to use a watch/clock to time the 5 seconds. You may collect your urine in a clean dry cup and immerse the entire Absorbent Tip in the urine for 5 seconds only if preferred.
The FIRST RESPONSE™ Digital Pregnancy Test is designed to detect hCG as early as 6 days before your missed period (5 days before the day of the expected period). The amount of pregnancy hormone increases as pregnancy progresses2.
The FIRST RESPONSE™ Digital Pregnancy Test is >99%2 accurate from the day of the expected period in laboratory studies.
However, some pregnant women may not have detectable amounts of pregnancy hormone in their urine on the day they test or may have miscalculated the first day of their period.
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™ 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.
A ‘?’ symbol indicates an error has occurred during testing. You should retest with another FIRST RESPONSE™ Digital Pregnancy Test, carefully following all directions.
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.
Your result will be displayed for at least 30 minutes. Read your results within this timeframe. 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.
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.
Once removed from the wrapper, the device must be used within 12 hours. Keep the device dry before use.
Only medications containing the pregnancy hormone (hCG) can affect the result. The test should not be affected by hormone therapies containing Clomiphene citrate, alcohol, pain killers, antibiotics, or the contraceptive pill. Consult your doctor on which drugs can affect the test.
READING YOUT RESULTS AT 3 MINUTES
in approximately 3 minutes, an unmistakeable ‘YES+’ or ‘NO-‘ will appear on the Display Screen.
PLEASE READ ALL THE INFORMATION IN THIS INSERT BEFORE PERFORMING THE TEST
If you have any questions please call our advice line.
(Monday to Friday 8.30am – 5.00pm AEST)
AUS: 1800 222 099 NZ: 0800 380 218
2 In a study conducted by Church & Dwight Co. Inc under diagnostic protocol #330 to evaluate the First Response Digital pregnancy test’s ability to detect hCG hormone as an aid in the early detection of pregnancy in the days before the missed period, a total of 504 urine samples from 50 characterized cycle segments taken from conceptive cycles were collected from 50 different pregnant women. The study showed that the hCG hormone was detected in 60% of pregnant women, 6 days before the missed period (5 days before the day of expected period), in 86% of pregnant women 5 days before their missed period, in 96% of pregnant women 4 days before their missed period, >99% of pregnant women 3 days before their missed period.
Church & Dwight Co. Inc. conducted a study based on protocol # 332 to determine First Response Digital pregnancy test’s analytical accuracy and determine equivalence of this device to the predicate device.
A total of 600 urine samples were tested 300 of these were urine samples collected from non- pregnant women and 300 from pregnant women. Each sample was tested with both one predicate device (Firt Response Early Result In Stream) and one from the randomized subject device (First Response Gold Digital
The results of the study demonstrated an overall laboratory accuracy of 100 % for each of the three batches. The combined analytical accuracy of the three batches is also at 100 % with the lower limit of the 95% confidence level at 99.5%
Based on the results obtained on the study the First Response Gold Digital Pregnancy Test is >99%and is also substantially equivalent to the predicate First Response early Pregnancy Test.