CRISTINA MARTINEZ BYVIK
/ Union-Tribune
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For nearly four decades, women have used home tests to find out if they are pregnant.
More recently, they've been able very early in the pregnancy to determine if the child is a boy or a girl.
Now, men can use a home testing kit to find out if Junior is really theirs. And with the latest innovation in home testing, both parents cainvestigate with 97 percent certainty whether Junior is on drugs.
At-home diagnostic kits – there are several hundred, all approved by the Food and Drug Administration – allow people to test themselves and family members in these circumstances and more. The kits offer privacy and confidential results without the hassle of a doctor's appointment.
The kits, available online and over-the-counter at drug stores, analyze saliva, urine and blood for numerous conditions, including HIV and ovulation. The most popular tests by far are those that help diabetics keep track of glucose levels in their blood.
DAN TREVAN / Union-Tribune
Monitoring blood-glucose levels at home has turned into a $5.5 billion-a-year business.
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Top-selling home
diagnostic tests
Market segment size in 2005
Blood-glucose monitoring – $5.5 billion
Pregnancy – $400 million
Ovulation – $50 million
Blood-thinner monitoring – $30 million
Others (cholesterol, occult blood, urine) – $60 million
Total – $6.04 billion
Source: Enterprise Analysis Corp.
TO LEARN MORE
 For more information about how to choose and use over-the-counter medical tests, go to www.labtestsonline.org.
For information about HIV home tests, go to www.fda.gov/cber/.
The FDA's Office of In Vitro Diagnostic Device Evaluation and Safety provides basic information about home-use medical tests as well as a link to a search mechanism that allows you to check whether a test is approved by the FDA. If you don't know the name of a test, just put in “ovulation” or “glucose” or another general term.
FDA info: www.fda.gov
Search link: www.accessdata.fda.gov
– FROM STAFF AND WIRE REPORTS
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Once a source of concern and controversy in medical circles, the tests are now considered a convenient, relatively safe way for patients to claim a piece of their own health care.
Some over-the-counter kits require a sample to be collected at home and mailed to a lab for results. For example, customers can purchase a paternity test for $400 from Genelex Corp., a Seattle company that offers DNA testing. The test-taker swabs his cheek and sends the sample to the company's lab. Results are available in five days. Genelex has reported a 300 percent growth in home paternity test sales since September 2002, with 2,300 kits purchased.
Other tests offer at-home answers and are often less expensive. A test that indicates whether a woman has started menopause, for example, sells for $19.99 at most drug stores.
Petrie Rainey, director of the clinical chemistry lab at the University of Washington Medical Center, said such tests are good for consumers. But even professionals can make mistakes in the lab, Rainey cautioned.
“So a lay person, I'm sure, can do an even better job of misconstruing instructions,” Rainey said.
Worldwide sales of at-home diagnostic kits (which reveal results at home) have increased from $2.9 billion in 1999 to more than $6 billion in 2005, said Mark Hughes, a consultant with Enterprise Analysis Corp., a health-care market research company in Stamford, Conn. Some doctors are even prescribing the tests for their patients.
A prescription test that monitors levels of blood-thinning medications is growing in popularity, said James Nichols, director of clinical chemistry for Baystate Medical Center in Springfield, Mass., and an associate professor of pathology at Tufts University in Medford, Mass.
The at-home tests are a “natural growth out of this preventive medicine trend,” Nichols said.
For busy patients and doctors, testing at home just makes sense, said Ken Adams, owner of AbDiagnostics Inc., a Melbourne, Fla., company that sells about 40 at-home tests online.
“If a test is (positive), then they obviously go into the doctor to have further evaluation,” said Adams, who founded the company 10 years ago. “If everything is fine, then you don't have to waste half a day” going to the doctor.
Of course, autonomous testing also means patients are potentially alone when they receive devastating news.
To address that, the FDA requires companies that provide HIV and hepatitis C results over the phone to offer counseling for people who receive positive results.
Opting to test yourself is one thing, but scrutinizing your child's bodily fluids for evidence of an infectious disease or drug use raises ethical red flags, said Helene Starks, assistant professor of medical history and ethics at the University of Washington.
The FDA recently approved the first at-home test for prescription drugs. The test detects methadone, oxycodone, antidepressants, barbiturates and benzodiazepines, as well as a battery of illicit drugs in urine. Results are available in five minutes.
First Check Diagnostics, a Lake Forest company that makes the First Check 12 Drug Test, has said parents can use its product to check their children for drugs. The FDA suggests sending the sample to a lab to double-check results.
“It certainly gets murky,” Starks said. “You have to ask parents to clearly define for themselves: What's the benefit of this? Are there other less intrusive ways that might not undermine trust?”
