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Test cases

Patient, test thyself.

The expanding world of home medical tests is making it easier for us to monitor and maintain our own bodies. Kits are available now over the counter that can check blood sugar, look for colon cancer, test blood pressure, detect urinary tract infections, determine cholesterol levels and discover pregnancy -- as well as the best time of month to make it happen.

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The benefits of home testing are clear, physicians say. An early awareness of pregnancy can translate into better prenatal care. Closer monitoring of glucose can mean fewer diabetic complications. Early cancer detection may lead to more successful treatment of the disease. Discovering a high cholesterol level can promote a healthier lifestyle to prevent heart disease.

Also, the tests are approved by the Food and Drug Administration, many are cheaper than their laboratory counterparts, and -- praise to the universe -- you don't have to make a doctor's appointment to get the information you want.

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Yet caveats exist.

"Not all people are reliable observers and reliable testers, especially if they want to deny any decline in their health status," says Dr. M. Roy Schwarz, senior vice president for medical education and science for the American Medical Association. And, he says, the tests should not be a substitute for regular checkups or a more complete evaluation of a person's overall health.

Some physicians have raised concerns about the nation's first home testing kit for cholesterol, approved by the FDA in March. Designed to measure overall cholesterol levels, the test does not check the HDL, or "good" cholesterol, and the LDL, or "bad" cholesterol. Physicians worry that consumers might not realize the necessity of seeking such detailed information.

"It is important not only to measure total cholesterol, which is what the kits do, but also to measure fractions or components of cholesterol," says Dr. Robert Vogel, director of the division of cardiology at the University of Maryland Medical Center.

No substitute for diagnosis

"Home tests are no substitute for the initial diagnosis or treatment plan," he says.

But he does approve of home tests as part of physician-monitored treatment. For example, if a person has already been diagnosed as having high cholesterol, the home test can help monitor it.

In order to be approved by the FDA, home tests must be proven as safe and effective as those used in professional laboratories. But the agency does caution that the chance for error with home testing is increased because the test does not take place in a laboratory setting.

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Dr. Daniel Symonds, chief of pathology at Union Memorial Hospital, suspects that many home test users lack sufficient knowledge to evaluate some of the results.

"In some cases, the test is all or nothing -- like a pregnancy test -- but in most situations, if you measure anything in the body you will find that there is no one normal number -- there is a range of normal numbers," he says.

"Sometimes patients who get their own lab results focus on very borderline abnormalities and do not realize that they may not be significant. . . . A physician has had years of experience with many patients with similar problems, and he can assess the significance of a test's results objectively."

Because medical tests carry so many psychological implications, the FDA has not approved any home tests for the detection of AIDS. Health care workers believe such sensitive data must be accompanied by expert counseling.

Diabetes success story

Perhaps the biggest medical success in home testing has been the glucose monitoring kit. Last week the American Diabetes Association announced that multiple daily monitorings of glucose levels -- a breakthrough made possible by home kits -- can dramatically reduce the medical complications associated with insulin-dependent diabetes.

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"Patients have more control of their own situation," says Dr. Philip Levin, associate professor of pediatrics at the University of Maryland Medical Center and one of the principal investigators for the national Diabetes Control and Complications Trial, which produced the new data.

"Home tests won't eliminate visits to the doctor, but there will be less guesswork and more facts to work with. It will be more of a team effort, with the patient a bigger part of the team."

Arthur Caplan, director of the Center for Biomedical Ethics at the University of Minnesota in Minneapolis, says home kits can lower health care costs by shifting testing out of more expensive locations. He doubts the growing market will threaten the pathology business, however, partly because many home test consumers would not necessarily have visited a lab instead.

"I guess the crass truth is that if a home test screening picks up some condition, the labs still need to do the follow-up," he says. "Home tests are not supplanting the role of the pathology labs, they end up feeding them more business -- like confirming false positives."

Spawning hypochondria

He believes that as home medical testing increases consumers' awareness of their health, it will also lead to more hypochondria. He imagines that more people than ever will stew over whether they have such minor conditions as lactose allergies -- and he foresees an increase in health hypocrisy.

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"I can't tell you the number of people I see out there who are already testing their body chemistry -- things like their fat levels -- while they're still smoking. There's a lot of that kind of thing out there: You know, the people-who-don't-exercise-but-take-lots-of-vitamins syndrome."

A nation of testers?

Dr. Caplan says home tests feed the national passion for self-evaluation. Americans love testing themselves, he says, whether they use a cholesterol kit or a questionnaire that rates their intimate relationships.

The growth in home testing may also indicate problems in American health care, says Dr. Daniel Ford, assistant professor of medicine, epidemiology and health policy at the Johns Hopkins School of Medicine.

"When you have to do cancer screening at the home or the work site, it's a failure of the system. We should be able to provide primary care facilities that patients feel are user-friendly and affordable. That should still be the ideal we strive for."

BEFORE TESTING

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Home medical tests are never 100 percent accurate, cautions the FDA. Agency staff-member Dixie Farley recommends you consider the following before taking such a test:

* Note the expiration date of test kits that contain chemicals.

* Pay attention to whether the product needs storage protection from heat or cold.

* If directions aren't clear, don't guess what they mean. Consult a pharmacist or health professional or check the package insert for a toll-free 800 number.

* Review what the test is intended to do and its limitations.

* Note any precautions, such as avoiding exercise or food or drugs before taking the test.

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* Follow the sequence of instructions exactly. Don't skip a step.

* Wash urine specimen containers with distilled water, which is usually purer than tap or bottled water.

* When a step is timed, be precise. Use a stopwatch or a watch with a second hand.


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