Oak Lawn’s Thomas Stanton had no pain, no family history of heart problems and no reason to think he was a ticking time bomb. Still, to humor his son-in-law, he agreed to try a new, comprehensive at-home cholesterol test.
When the results returned in the mail, they suggested the 72-year-old retired insurance broker visit his doctor. When Stanton did, he was promptly admitted to the hospital, where surgeons discovered what they call widow makers: several clogged arteries, including one that was 90 percent blocked.
“I wouldn’t have him here today if it wasn’t for that home test,” said Stanton’s wife, Helen, who also tried the $29.95 Cholesterol Panel created by the Lake Forest-based company Biosafe Medical Technologies. “We didn’t have a clue he had a heart problem.”
Self-tests have come a long way since pregnancy tests were first carted home in the 1970s. Not only can women test for menopause, but consumers also can screen themselves for diseases and conditions such as high cholesterol, hepatitis C, HIV, colon cancer, prostate cancer, male infertility and food allergies, all in the comfort of their own bathroom.
Convenience, rising health care costs and a desire for privacy are several reasons why the market is expanding. Some offer results within minutes, while others must be mailed off to a certified lab for analysis. Regardless, officials with the Food and Drug Administration and test manufacturers say the products are designed to calm fears and assist doctors, not replace them.
Westchester’s Peggy Falduto, 37, who takes the anticoagulant Coumadin, made weekly trips to the doctor for testing until she bought a $2,000 home blood testing machine.
Though it was ex-pensive, she wouldn’t trade it for anything. Her results are ready in three minutes.
“It’s been life changing and given me peace of mind,” said Falduto, a nurse who suffers from Marfan syndrome, a connective tissue disorder. “I know that if I’ve eaten a salad, which makes clotting increase, I can check it that night. Or if I had a cocktail, which makes my blood thinner, I can check it again.”
But Falduto, a good candidate for at-home tests given her nursing background, is still the exception among patients on anticoagulants, sometimes called blood thinners, even though the technology exists.
“This is only speculation, but the limits on the tests are that people don’t like to stick themselves, or draw blood on their own,” said Steve Gutman, director of the FDA’s office of In Vitro Diagnostic Device Evaluation and Safety.
And whether some of these tests really work and whether they encourage people to bypass the doctors’ office altogether concern both physicians and the American Medical Association, which is warily watching direct-to-consumer advertising for diagnostic tests.
Thanks to the Internet, consumers have access to non-FDA-approved tests that promise to do everything from determine the gender of a child to screen for Alzheimer’s and osteoporosis. (The three cannot be done accurately through home testing, experts say.)
Even FDA-approved tests have limitations.
The missing link
“The problem with many of them is there is no trained advice,” said David Baldwin, an endocrinologist at Rush University Medical Center. “You get a number and then what do you do? You go back and do what you should have done in the first place: See a doctor who can put it in context with your overall health and family history.”
The twin epidemics of obesity and diabetes are fueling the U.S. self-diagnostics market, which totaled $842.9 million in sales in 2003, according to the research firm Mintel International Group. The most popular home tests are the old standbys that doctors generally trust: blood pressure monitors, glucose meters and pregnancy tests.
Although the market is broader than ever, it also is largely untapped. A recent poll found that 49 percent of the respondents expressed interest in home cholesterol kits, but less than 2 percent of the poll takers reported using them, according to the research group FIND/SVP Inc.
That could change, especially with new, more intensive guidelines for lowering cholesterol recently issued by the National Cholesterol Education Program. Under the recommendations, more than one in six people nationwide should get cholesterol-cutting drugs known as statins, to reduce the chance of heart attack and stroke.
Companies producing and marketing the testing products believe that if more people are taking prescription drugs, there could be a greater desire to monitor the results. In addition, if cholesterol medications become available over the counter, the FDA will want consumers to have more testing, rather than less, said Dave Fleisner, president of Biosafe.
“There are probably 10 million people on cholesterol reduction medication, and none of them knows how well it’s working,” Fleisner said.
Incomplete picture
One problem has been that home testing kits were fast and convenient but, until recently, gave only the total blood cholesterol level.
“Total cholesterol means nothing,” Baldwin said. “You need to do a full profile, and the only way to do that is to send it to a lab.”
The better way, physicians say, is to get a full lipoprotein profile, which includes a breakdown of the amount of high-density lipoprotein cholesterol (HDLs), the kind that helps protect the heart; low-density lipoprotein (LDLs), which can clog the arteries; and trigylcerides, which are fats in the blood.
The FDA-approved Biosafe cholesterol panel test, which is available through the Internet and expected in Osco-chain stores by September, allows consumers to draw their own blood sample and mail it to a lab. The results are reviewed by physicians and returned by mail.
“Often, we give people slips to get their blood cholesterol taken and three months later it’s stuck in a book or they forget to show up for the followup,” said Dr. Vincent Bufalino, President of Midwest Heart Specialists in Naperville, which is conducting a pilot program on home cholesterol testing.
Hoffman Estates-based Home Access Health, which sells an FDA-approved home test for total cholesterol, has a full-profile test in the pipeline. Home Access also produces the only FDA-approved tests for HIV and hepatitis C and markets an at-home allergy test.
The company works with the American Medical Association and has a referral base of physicians and social workers on hand who are trained in disease counseling.
Power to the patient
“The key is to make sure we’re empowering patients,” said Joe Smith, a spokesman for Home Access Health. “A doctor’s time is so stretched that it’s much better if people come in as informed consumers.”
For Stanton, now 74, there was no question that the home test was useful. A diabetic, he already monitored his blood sugar and made frequent trips to the doctor. Still, no one suspected heart trouble and he likely wouldn’t have had his cholesterol tested if his son-in-law wasn’t Jack Maggiore, Biosafe’s chief scientific officer. The day before Stanton was hospitalized, he played nine holes of golf and cut the grass.
He even waited a month between getting the bad results and taking them to his doctor. “If they hadn’t found that cholesterol thing, I would have just gone on my merry way,” said Stanton, has used the test several times during the last two years and watched his cholesterol levels improve. “It was just an act of God I was handed that kit.”
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The kits at a glance
Note: More detailed, specific instructions come with each kit.
THE MYALLERGY TEST
($69.95) BY IMMUNETECH
by ImmuneTech
Claim: Blood samples will determine if you have allergies to 10 common allergens.
Your job: Send in a small blood sample; results available via the Internet or mail.
www.homeaccess.com
ALLERGEN ALERT FOR THE HOME ($49.99)
BY IMMUNETECH
Claim: Assess indoor air quality by detecting and identifying the levels of common allergens.
Your job: Deploy dust collector traps, then send the traps to the lab. Results sent via mail in three to four weeks.
Quote: “False positives are high with home allergy test kits,” said Brian Smart, an allergist with the DuPage Medical Group in Glen Ellyn and a spokesman for the American Academy of Asthma, Allergy and Immunology. “The reality is they have not been proven to be helpful. One weakness is it’s hard for someone using it to know what is normal and what is not.”
www.homeaccess.com
EARLY ALERT ALZHEIMER’S HOME SCREENING TEST ($19.95)
Claim: Measures loss of smell, an early indicator of Alzheimer’s disease.
Your job: Scratch, sniff and correctly identify 12 scents. The questions are multiple choice.
The test itself warns: “Poor performance on this screening test does not necessarily mean you have Alzheimer’s.”
www.alzheimerstestkit.com
THE BIOSAFE CHOLESTEROL PANEL BLOOD TEST ($29.95)
FDA approved
Claim: measures the amount of total cholesterol in your blood, including the amount of HDL cholesterol, triglyceride level and LDL cholesterol value.
Your job: Prick your finger, dab blood on four spots and mail to the lab.
Quote: “It’s great from the standpoint that the main components of a lipid profile are reported,” said Julie Kozlowski, an advance practice nurse with Midwest Heart Specialists in Naperville. “However, it currently does not report liver enzymes, which some patients need once or twice a year. The drawback is that some patients still need to come in for additional labs.”
www.ebiosafe.com
CHOLESTRAK HOME CHOLESTEROL TEST
($17 for two tests)
FDA approved; available in drugstores
Claim: Measures total cholesterol.
Your job: Draw a few drops of blood; results available in 10 to 12 minutes.
Instant results, but most experts say the biggest drawback are these tests don’t give a total breakdown of cholesterol levels.
www.accutech-llc.com
HOME ACCESS EXPRESS HIV TEST ($59.95)
The only FDA-approved home test kit; available in drugstores
Claim: 99.9 percent accurate.
Your job: Send a small blood sample to the certified lab. Using a code, call for results after three business days.
Home Access is your best bet. The FDA cautions against using HIV home test systems and kits found on the Internet that claim to detect antibodies to HIV in blood or saliva samples and provide results in the home in 15 minutes or less. “The FDA has not approved these rapid HIV-1 home test kits being promoted on the Internet for use and marketing in the United States.”
www.homeaccess.com
HOME ACCESS HEPATITIS C TEST ($59.95)
FDA approved, available in drugstores
Claim: 99 percent accuracy.
Your job: Call and register; send a small blood sample to the lab. Call the same toll-free number in 10 business days for test results and post-test counseling.
Quote: “They are a nice, confidential way to decide whether you do need see doctor,” said Jackie Dominguez, director of the American Liver Foundation. “Some people prefer the convenience, and they can be a less expensive way for initial testing.”
www.homeaccess.com
MENOCHECK MENOPAUSE INDICATOR TEST ($19.95)
FDA approved, available in drugstores
Claim: Rapidly detects surges in levels of a hormone called follicle stimulating hormone (FSH).
The woman’s job: Urinate on the absorbent tip of the test device or into a cup and dip the tester into the cup. Check the results after five minutes.
Quote: “I like the concept of the FSH test,” said Dr. Michael Zinaman, a reproductive endocrinologist at Loyola University Medical Center. “It behooves women to really read through the educational material. Menopause is a natural process–you’re not ill or sick–but it’s also a time when symptoms can be quite bothersome. If women want more information, of course, they should sit down with a gynecologist who understands the nuances of the test.”
www.menocheck.com
BABY START MALE INFERTILITY TEST ($32.99)
Available in drugstores
The male’s job: Add a semen sample to a test cassette; results available in 15 minutes.
Claim: “The test determines whether your sperm concentration is above or below 20 million sperm cells per milliliter.”
Quote: “The tests are based on whether enough moving sperm in an ejaculation can turn the kit positive,” said Randy Morris, a Chicago endocrinologist and fertility expert. “It’s not bad for a basic understanding. There are lots of ways it can be fooled, but if a couple is just starting out and is worried there aren’t enough [viable] sperm, they might go to the doctor sooner rather than later.”
www.lakeconsumer.com
GENSELECT GENDER SELECTION ($199)
Claim: Adjusts the body’s condition to influence gender during impregnation.
The woman’s job: Take nutriceutical supplements, track ovulation and body temperature, douche to influence the acidity of the vagina and follow a controlled diet.
Quote: “It might be fun for entertainment purposes perhaps, but to select or predict the gender of child, it’s pretty much useless,” said Chicago endocrinologist and fertility expert Randy Morris. “The only real method that affects the sex is invitro with pre-implantation genetic diagnosis (PGD).”
www.genselect.com
— J.D.
