Our unique multi-pack offers both in-stream and digital tests for your peace of mind. The FIRST RESPONSE™ Early Result In-Stream Pregnancy Test is sensitive enough to give you results 6 days before your missed period (5 days before the day of your expected period)1. When a positive result is indicated, the FIRST RESPONSE™ Digital Pregnancy Test can be used to confirm the result. It offers you easy to read Yes+ / No- results with a unique ‘test is working’ indicator that lets you know the test is ready for use and is over 99% accurate2.
ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.
The First Response™ In-Stream and Digital Pregnancy Test detects in urine the hormone your body produces during pregnancy; human chorionic gonadotropin (hCG).1 & 2
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 progresses. 2
First Response™ In-Stream and Digital Pregnancy Test is >99% 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.1 & 2
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.
If you test positive, but think you may not be pregnant, you should check with your doctor.
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.
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.
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 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.
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.
A positive (pregnant) test result shows that the pregnancy hormone (hCG) was detected. You should see your doctor to confirm that you are pregnant. Because this test detects very low levels of hCG, some women may test positive even if they are not pregnant.
You may not be pregnant, or it may be too early to tell. If you do not get your period within a few days, you should retest with another First Response™ In-stream 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 First Response™ In-stream Pregnancy Test to give a positive result. If you retest and again no hCG is found, and your period has still not started, you should call your doctor.
Your result should appear within three minutes. There should be at least one pink line in the Result Window at five minutes to indicate that the test is completed and that you have done it correctly. If not, the test is invalid. This could be due to insufficient urine on the Absorbent Tip or not holding the device with the Absorbent Tip pointing downward while replacing the Overcap. You should retest with another First Response™ In-stream Pregnancy Test, carefully following all directions.
Remove test stick from foil wrapper and remove the Replaceable Overcap. Holding the test stick by the Thumb Grip with the Absorbent Tip pointing downward and the Result Window facing away from your body, place the Absorbent Tip in your urine stream for 5 seconds only. It is recommended to use a watch/clock to time 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). With the Absorbent Tip still pointing downward, replace the Overcap* and lay the stick on a dry flat surface with the Result Window facing up. You may soon see a pink colour moving across the Result Window to indicate that the test is working. Read your results at 3 minutes, but within 10 minutes.
Remove test stick from foil wrapper and remove the Replaceable 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. Holding the test stick by the Thumb Grip with the Absorbent Tip pointing downward and the Display Screen, place the Absorbent Tip in your urine stream for 5 seconds only. It is recommended to use a watch/clock to time 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). With the Absorbent Tip still pointing downward, replace the Overcap* and lay the stick on a dry flat surface with the Display Screen facing up. Be careful not to get the urine on the Plastic Holder. During testing, never hold the device with the Absorbent Tip pointing upward. The clock symbol will begin to blink in about 30 seconds after urine is applied to indicate the test is working.
* Replacement of the Overcap is not necessary for the proper functioning of this test. The Overcap cap allows you to save the test in order to show a positive result to your partner or doctor.
CAUTION: THIS PRODUCT CONTAINS A LITHIUM COIN BATTERY.
This battery is hazardous and must be kept away from children.
This battery can cause severe or fatal injuries in 2 hours or less if it is swallowed or placed inside any part of the body.
Seek immediate medical attention if it is suspected the battery has been swallowed or placed inside any part of the body.
FIRST AID: For advise, contact a Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766), or a doctor at once.
PREGNANT
TWO PINK LINES
in the result window.
(One line may be lighter than the other, they do not have to match.)
NOT PREGNANT
ONE PINK LINE
in the result window.
(There will be no react of a second line.)
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
1 Church & Dwight Co. Inc. conducted a study based on protocol # 172 to determine First Response In Stream pregnancy test’s ability to detect hCG hormone as an aid in the early detection of pregnancy in the days before the missed period. Approximately 575 urine samples from 52 different conceptive cycles were used. The study detected an increase in hCG hormone in 62% of women, 6 days before the missed period (5 days before the day of expected period), in 78% of women 5 days before their missed period, in 87% of women 4 days before their missed period, in 98% of women 3 days before their missed period and in 99% of women 2 days before their missed period
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.
6 Church & Dwight Co. Inc. conducted a study based on protocol # 187 to determine First Response In Stream pregnancy test’s analytical accuracy of over 99 % and results in 3 minutes. A total of 201 early pregnancy urines were tested 100 of these being hCG negative and 101 being hCG positive. Three batches were used for the accuracy studies and all results showed correct negative and positive results. The results of the study indicated that First Response In Stream Pregnancy Test when tested with urines from non -pregnant woman and early pregnancy urines demonstrated an overall laboratory accuracy of over 99 %. The results were also visually read and recorded at 3 minutes.
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.
