New Test Gives Women Two Essential Answers and More Information Than They Have Ever Had Before
CINCINNATI--(BUSINESS WIRE)--At the 61st Annual Clinical Meeting of the American Congress of Obstetricians and Gynecologists (ACOG) in New Orleans, Clearblue unveiled the newest addition to their family of products that will change women's home pregnancy test experiences forever. Cleared by the Food and Drug Administration (FDA), the new Clearblue Advanced Pregnancy Test with Weeks Estimator not only tells a woman if she is pregnant but also estimates the number of weeks since ovulation (when egg is released to be fertilized by sperm).
“Confirming pregnancy is a life-changing moment in any woman's life, and it sparks so many immediate questions like when did I get pregnant? That's why we are thrilled to be able to bring the new Clearblue Advanced Pregnancy Test with Weeks Estimator to women in the United States,” said Kirsten Suarez, Clearblue brand manager. “This test was created based on years of qualitative and quantitative consumer research and a clear understanding that a woman wants as much information as possible as soon as she receives a positive result. The Clearblue Advanced Pregnancy Test with Weeks Estimator gives her more information right at the beginning of this new phase in her pregnancy journey than she's ever had before.”
Currently, the majority of physicians estimate weeks of pregnancy using a formula based on a woman's last menstrual period. However, one in six women do not have a last menstrual period recorded1 and approximately 70 percent are uncertain of their last menstrual period.2
The Clearblue Advanced Pregnancy Test with Weeks Estimator uses new technology that takes two measurements instead of one and not only gives an accurate pregnancy result but also estimates the number of weeks since ovulation. The test is more than 99 percent accurate in detecting pregnancy from the day of the expected period, and it is approximately 93 percent accurate in estimating how many weeks based on time since ovulation3. All results should be confirmed by a doctor, especially when making decisions about future medical care.
“The new Clearblue Advanced Pregnancy Test with Weeks Estimator is an exciting innovation that clearly demonstrates the amazing advancements we've made in this category over the last 30 years,” said Michael Zinaman, MD. “While women must still make appointments with their physicians to confirm, date and monitor pregnancy, this test provides women and their physicians with valuable information from the very beginning of pregnancy, more than any other test currently available.”
How It Works
All home pregnancy tests are designed to detect the hormone hCG in urine to determine pregnancy. However, the Clearblue Advanced Pregnancy Test with Weeks Estimator also measures the concentration of hCG, which helps estimate when fertilization occurred. If the test is positive, ‘Pregnant' will be clearly indicated in words on the display along with an estimate of how many weeks have occurred since ovulation: 1-2 weeks, 2-3 weeks or 3+ weeks.
The launch of this product is supported by a wealth of clinical data. A multi-center, prospective study was conducted in the US to evaluate the Weeks Estimator results. Women were recruited pre-conception, providing 153 pregnancies for analysis. In this study, agreement between Clearblue Advanced Pregnancy Test with Weeks Estimator results and time since ovulation (when the egg is released to be fertilized by sperm) was 93% 3.
The Clearblue Advanced Pregnancy Test with Weeks Estimator will be available in stores and online in September 2013. This will be the second product innovation added to the Clearblue product portfolio this year as the Clearblue Advanced Digital Ovulation Test, the first and only test that typically identifies 4 fertile days, was introduced in early 2013.
Indications for Use
The Clearblue Advanced Pregnancy Test with Weeks Estimator is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test detects hCG in some cases from 4 days before the expected period (which is 5 days before the day of the missed period). The test is only intended for individual use at home. It is not intended for use in a healthcare setting. This test contains a Weeks Estimator. The Weeks Estimator is meant solely as an estimate for the consumer and is not intended as a substitute for a doctor's clinical diagnosis. The Weeks Estimator is not intended for multiple pregnancies. The estimate provided by the device may be inaccurate in these cases. This test cannot be used to determine the duration of pregnancy or to monitor the progression of pregnancy. Your doctor determines how many weeks pregnant you are based on the first day of your last menstrual period and ultrasound results. This test provides a different estimate that cannot be substituted for a doctor's determination of gestational age. Only your doctor can monitor pregnancy progression. You should seek qualified prenatal care if you suspect you are pregnant.
Always read full information on pack and package insert before use.