-- Forget the office visit. Home-health exams can save time and
money, and give patients some control.
Twice a year, Mary Shomon officially checks her ever-fluctuating
thyroid hormones -- but without bothering to leave her home for a
trek to a lab or doctor's office.
Instead, she pricks her finger with a tiny lancet provided in a
thyroid test kit she orders over the Internet. The blood spots
onto a small filter strip, which Shomon then mails to a lab.
There, it's analyzed for the levels of thyroid hormones and
antibodies. The results are sent directly to her home in
Kensington, Md. Shomon shares the results with her doctor, who
then adjusts treatment, or not, accordingly.
"I monitor my thyroid condition between doctor's visits or when I
want to get a little more information," said Shomon, who has
written several books on thyroid disease, including the 2004
bestseller "The Thyroid Diet: Manage Your Metabolism for Lasting
Weight Loss" after her diagnosis with Hashimoto's hypothyroidism
in 1995. Hashimoto's disease is an autoimmune condition in which
antibodies attack the thyroid gland. "I have a very cooperative
doctor who has always been a partner."
Like Shomon, health-obsessed, time-pressed and cost-conscious
Americans are discovering that home-health tests can give them
some control over their own health and medical conditions. Some
tests are used to monitor existing conditions such as diabetes
and high cholesterol; others screen for new problems.
If test results detect no changes or no new conditions, an
expensive and time-consuming doctor's visit can often be avoided.
If the tests detect an ailment or change, the results add impetus
to the need for care. For the uninsured and, sometimes, even the
insured, a test can cost less than a co-pay or a visit to an
out-of-network doctor. At $200, Shomon's thyroid test, which
includes lab work, is less expensive than visiting her doctor
(who is not a provider on her insurance plan) and paying the
subsequent lab fee. The thyroid medications, which Shomon's
doctor tweaks according to the lab readings, are covered by her
insurance, however, and become a part of Shomon's medical
That's not to say testing always saves money. A urinary tract
infection kit may cost only about $13.99 at a pharmacy, but if
the test is positive, treatment will require a prescription from
a doctor. And the doctor will likely want to confirm the
diagnosis with another test. Unless the test is negative, that's
hardly a savings if one must pay the test cost, plus a doctor's
visit fee or co-pay.
But the twin benefits of control and empowerment are essential to
people who want more nuanced information about their health than
perhaps their doctor deems necessary or than their insurance
company is willing to fund. Home-health tests allow a consumer to
get information without being at the mercy of a physician's
"Home-health tests that are safe and effective allow patients
more control over some of their care," wrote Dr. Diane
Rittenhouse, a family and community medicine specialist at UC San
Francisco, who responded by e-mail. "A patient who self-diagnoses
high cholesterol can change their diet and exercise, share
results with their physician or do nothing. Ideally, care occurs
in a partnership between patients and physicians."
Added Dr. Lori Heim, president of the American Academy of Family
Physicians: "People are paying for these tests out-of-pocket, so
that tells me that there is tremendous market out there."
Analysts for marketing and consulting companies specializing in
healthcare estimate that Americans spent about $4.5 billion in
2008 on over-the-counter home health tests, compared with $3
billion in 2005. The annual growth rate is projected at 7% to 8%
a year, presumably reaching $5.68 billion by 2013, according to
Scientia Advisors, an international consulting firm.
About 85% to 90% of the market is blood glucose and pregnancy
testing. But the array of tests now available to consumers is
significantly larger. Tests for cholesterol, colon cancer, drug
and alcohol abuse, blood glucose, hepatitis C and HIV can be
found in pharmacies. And a veritable arsenal of tests is
available for sale online, including ones for strep, sexually
transmitted diseases, and bowel and prostate cancer.
Just last month, the Los Angeles County Department of Public
Health launched a program offering free home-collection test kits
for gonorrhea and chlamydia (available online at
www.dontthinkknow.org or by calling  758-0880). The program
is modeled after a successful outreach program based in Maryland
that tests for gonorrhea, chlamydia and trichomonas vaginalis (a
sexually transmitted parasite).
Untreated, gonorrhea and chlamydia, the latter of which affects
mostly women ages 15 to 24, can cause infertility, pelvic
inflammatory disease and dangerous ectopic pregnancies.
Test specimens (a vaginal swab is placed in a specimen bag and
mailed postage paid to the Public Health Laboratory) are
processed in a week; confidential results are available online or
by phone. Women can choose to be notified by e-mail or text
Those who test positive are given nearby clinic locations and
free or no-cost treatment (both diseases are treated with
antibiotics). The department is also offering free counseling by
health educators at (800) 758-0880.
"Physicians are very concerned that people won't seek testing
[for sexually transmitted diseases] because of embarrassment and
privacy concerns," Heim said. "At-home tests eliminate those
concerns; without such privacy, some patients might never get
Treatment, of course, requires a doctor's guidance, especially if
prescription drugs are involved. And doctors say that's for the
"As good as it is for patients to be actively involved in their
own healthcare," Heim said, "it also has a downside if the
patient is acting alone without anyone there to guide them or
It's worth noting, however, that many physicians also feared the
effect of at-home HIV tests. "There was a concern that people
would not go and get proper counseling because they would decide
[a positive result] was a death sentence," Heim said. That fear
In 1996, the FDA approved the first (and to-date only) test for
HIV -- the Home Access HIV-1 Test System or the Home Access
Express HIV-1 System, which includes post-test counseling.
(Beware the many impostor HIV tests illegally marketed online,
the FDA warns.) Sometimes, the tests rule out possible infections
or diseases. But positive results should be reviewed by a doctor.
Physicians view tests results through the prism of family
history, individual health history, age, lifestyle habits and
other factors detected through a physical exam.
"If the results of a test do not fit a patient's clinical
profile," Heim said, "then the doctor gives the test again.
Sometimes a patient will have something in their blood like
antibodies that interfere with the formulations of a test. A
physician can see red flags easier than a patient can."
As for Shomon, home-health tests simply allow her to take charge
of her chronic condition so that she and her doctor can fine-tune
treatment as stress and hormonal changes affect how well her
thyroid functions and how she feels day-to-day.
"Medical test kits put some aspects of the decision process in
the hands of the patient instead of the HMO, or the insurance
company or the doctor," Shomon said. "Given the wait lists for
doctors appointments and HMOs that sometimes put cost containment
above patient interests, there are benefits to patients having
Interested in a test you have seen marketed online? To check its
FDA status, go to www.fda.gov, search for "IVD Over-the-Counter
Database" and then check for FDA approval. Or call (888) INFO-FDA
or (888) 463-6332.
** CORRECTION: An article in Monday's Health section said
the Home Access HIV-1 Test System (also known as the Home Access
Express HIV-1 Test System) was the first home HIV test to receive
Food and Drug Administration approval. The Confide HIV Testing
Service received FDA approval first, on May 14, 1996. That test
was later taken off the market by its manufacturer because of a
lack of demand. The Home Access HIV-1 Test System received FDA
approval on July 22, 1996.