Since its drugstore debut in 1977, the home pregnancy test has allowed countless women to know whether they’re expecting. But information was limited to this binary; to find out how pregnant she was, a woman had to receive an ultrasound. Now that process has an intermediary, a home pregnancy test that indicates with 93 percent accuracy whether a woman is 1-2, 2-3, or more than three weeks pregnant.
How The Test Works
The test comes from Clearblue, whose Advanced Pregnancy test with Weeks Estimator has already been available in Europe since 2008. In Dec. 2012, the Food and Drug Administration approved its use stateside, and on Sept. 1 the product will hit the shelves of all major retailers. The test itself uses two strips compared to most tests’ single strip, checking for the hormone human chorionic gonadotropin (hCG), which gets released after fertilization. The first strip confirms pregnancy, while the second strip estimates time since ovulation.
Clinical trials leading up to the test’s release totaled 5,000 urine samples from 2,000 women. Clearblue claims the test is 99 percent accurate at testing pregnancy from the day of a woman’s expected period, and about 93 percent accurate in estimating the number of weeks, TIME reports.
The test comes as a result of consumer preference, officials note, as many women want the maximum amount of information regarding their pregnancy in the shortest amount of time.
“We are living in an era where everyone wants an instant and immediate answer and have as much information as they can get," said Dr. Rebecca Brightman, an OBGYN at Mount Sinai School of Medicine in New York. “There are certain women with underlying medical problems or behaviors that I would like to see sooner rather than later for pre-pregnancy counseling. The more information I can get the more it helps me as a clinician.”
“Sooner rather than later” was a theme echoed by the test’s manufacturers, who specify the majority of women believe dating their pregnancy is crucial in the earliest weeks of their pregnancy.
“Through our consumer research, we found consumers were really wanting more information at the beginning of pregnancy,” Ryan Daly, marketing director at Procter & Gamble, who makes the test, told TIME. “In fact, 78% of women in our research study feel that knowing how far along you are at the beginning of pregnancy is very important.”
Not A Substitute For Ultrasounds
A home pregnancy test isn’t meant to act as a substitute for an ultrasound administered by a doctor, however. While tests can provide some information, truly accurate readings require clinical diagnosis — typically from a physician who can date the pregnancy based on the woman’s last menstrual period. Some doctors see minimal benefit outside women who experience irregular periods and, therefore, have a harder time retracing the exact date.
“I think some patients [for] who have really irregular periods [it] might be helpful,” said Dr. Christine Proudfit, assistant professor in the obstetrics and gynecology department at NYU Langone Medical Center. “But I think that for most women who have regular monthly periods, I don’t think it is going to give them a lot more information.”
However, many women simply find joy in using a home pregnancy test. Its efficacy in dating a pregnancy holds less importance than marking their impending motherhood — contrasted with the stigma of years past, when positive readings were generally considered a negative.
“We’re excited to bring this to the U.S. because there is nothing else like it,” Daly noted. “Consumers have been looking for more information and answers in the pregnancy test category and there hasn’t been any innovation since the digital pregnancy test was launched.”