FDA OKs Saliva-Based Ovulation Test
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) - Women wishing to become pregnant are about to
get a new way to predict when they are fertile: The government
has approved the sale of the nation's first saliva ovulation test.
Women's estrogen levels gradually rise each month, peaking with
ovulation, the time each month that they can conceive.
A woman can predict ovulation by measuring her body temperature's
rise with estrogen's rise, undergoing a blood test to check hormone
levels, or - more common - using a urine test that detects a surge
in an estrogen-related hormone 24 to 36 hours before ovulation.
The new TCI Ovulation Tester is a reliable alternative that women
may find less messy to use, Food and Drug Administration reviewer
Veronica Calvin said Friday.
Roughly 50 years ago, scientists realized that as estrogen surges,
the salt content of saliva increases, too, Calvin explained. When
the saliva of an about-to-ovulate woman dries, the salt leaves
a crystal pattern called ferning - it actually looks like a fern
plant - that can be seen under a microscope.
The new test is a round device that pairs tiny slides with a handheld
Touch a little brush to saliva in your mouth, then dab it onto
one of the slides. Let it dry and look through the eyepiece. If
there's only a little of the salt - potassium chloride - seen as
little dots, then ovulation isn't near yet. Test the next day and
you may see the dots starting to form chains. Once a true fern pattern appears, ovulation is imminent.
In studies comparing the saliva test to urine tests, the TCI Ovulation
Tester proved more than 90 percent reliable in indicating ovulation,
In fact, "one of the things that's interesting about this
test is you may be actually getting a little bit of warning that
you're getting close to ovulation by watching the pattern gradually
appear", said FDA medical device chief Dr. David Feigal.
With urine tests, in contrast, women have a chance of missing
ovulation depending on when they test, because the results are
given as a simple yes or no instead of suggesting whether hormones
are increasing, he said.
Manufacturer TCI Optics said it will begin selling the nonprescription
test, for $59.95, in a few weeks. Sales will begin via the company's
Internet site - www.ovulationtester.com - or by telephone at 1-866-OVULATION.
But the company is negotiating with larger medical firms in hopes
of beginning drugstore sales as well, a spokesman said.