Testing goes home

[Guest guest]

Testing goes home

Health officials offer caveats as products proliferate

By Schroeder

The Journal Gazette

Home testing has come a long way from a hand laid gently on the head and a thermometer tucked under the tongue.

Playing to consumers’ desire for convenience, potential cost savings and even added privacy, the home testing industry has continued to improve technology in areas ranging from cholesterol checks to HIV tests to blood glucose monitoring systems for diabetics. New tests are more accurate and easier to use.

Still, health officials caution consumers to choose products from reputable companies – especially if shopping on the Internet – and always read directions and warnings. For their part, consumers – perhaps wary of playing doctor – seem slow to embrace the full line of diagnostic tests.

Dan , a pharmacist at ’s Pharmacy in Village of Coventry, says he’s seen tremendous growth in demand for blood glucose monitoring systems.

Diabetics must regularly check their blood sugar levels. And they can’t run to the lab for every blood sugar check, tests that occur several times a day, said. Newer monitoring systems require less blood and provide more accurate results, he said.

The less painful, more reliable kits come at a cost, however. Depending on which bells and whistles they include, the price can range from less than $20 to about $80.

CVS.com lists a TrueTrack Smart System for $17.99 that features 30-day averaging of blood glucose levels. The Ascensia Contour Blood Glucose Monitoring System, which costs $79.99, even allows users to download their results on a personal computer.

But the real cost is test strips, used for each blood sugar test. Packs of 50 generally range from about $35 to $40, estimated. He said that Medicare Part B and many insurance companies cover the systems and strips, he said.

That’s not the case with diagnostic tests or perhaps the mother of all home tests, the pregnancy test. Yet at $10 to $15 – less than a typical co-pay at an OB/GYN – there’s savings to be had just the same. For this reason, many women check at home first before going to their gynecologist.

In general, however, consumers don’t seem to be supplementing doctors’ visits with home testing, according to Dr. Gutman. The pathologist directs the U.S. Food and Drug Administration’s Office of In Vitro Diagnostic Device Evaluation and Safety, which regulates in-home and laboratory diagnostic tests.

“Generally, people are smart enough to know they are not lab techs,” Gutman said. Rather than keeping people away from doctors’ offices, the tests complement those checkups by giving the “worried well” another tool to monitor their health, he said.

Gutman said home tests and monitoring systems – namely those to check blood glucose – have had a “profound positive impact” on care. While test options continue to expand in areas such as colorectal disease and Hepatitis C, there hasn’t been overwhelming demand for diagnostic tests.

For that reason, ’s Pharmacy stocks only the basics: pregnancy tests, ovulation tests (used to determine the optimal time to conceive), blood glucose monitoring systems and blood pressure machines.

Still, there is a market. So tests – such as the BIOSAFE Prostate Screen Kit, which is meant to be used to aid in the detection of prostate disease such as prostate cancer – are carried by many major pharmacies or at the very least available for order through their Web sites.

It’s in cyberspace that the market really opens up.

“The Internet is a very colorful marketplace,” Gutman said. Not only is it challenging to regulate, but many products from outside the country aren’t subject to FDA rules, he said.

Even products that claim to be FDA-approved might not be. If you’re not sure, Gutman recommends cross-checking tests with the FDA’s database on its Web site.

But Rudrappa Gangadhar has a different recommendation. The pathologist with Muncie-based Pathologists Associated, which has offices in Fort Wayne, thinks people should leave testing to professionals entirely.

Unlike Gutman, Gangadhar fears that patients using tests to diagnose an illness will not go to the doctor.

If they do, they have just paid twice for the same service, he said, once to check out a problem at home and again to have a doctor run a comparable test. In a worst-case-scenario, a patient could get a false negative and never go to the doctor at all, he said.

Gutman says accuracy rates for FDA-approved tests are comparable to lab tests and ease of use is a prerequisite to approval. In many cases, blood samples and the like collected at home are sent to outside labs for evaluation. That’s true of the Home Access HIV-1 Test System, which boasts a 99.9 percent accuracy rate. Still, Gangadhar, who insists he is not motivated by financial gain, believes that people should see their doctor to have tests.

“I’m not comfortable with any tests (that are) to be done by the layperson,” he said.

mschroeder@...

Home test tips

•Read the label carefully. The simplest step is often the most neglected and can lead to potentially serious testing errors.

•Make sure the source of your test kit is reputable. Though pharmacies are a safe bet, the Internet is wide open. If you’re not sure a test you’ve found is FDA-approved, visit .html.

•When in doubt about test results, call your doctor. And don’t skip out on regular visits.

•Don’t change your medication or dosages based on the results of a test without first consulting a doctor.

•Don’t go it alone. Call the manufacturer’s toll-free number on the test if you have any questions.

Source: U.S. Food and Drug Administration

http://www.fortwayne.com/mld/journalgazette/business/15056349.htm?source=rss & channel=journalgazette_business

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

http://www.homeaccess.com/

For Hepatitis C Testing Kits

http://www.homeaccess.com/02/02/