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Dealing with over-the-counter tests.

Dealing with over-the-counter tests Wandering down the aisles of my local pharmacy recently, I came across an array of pregnancy test kits, glucose monitoring kits, blood collection supplies, occult blood kits, etc. Next to video cassette rentals, home test kits seemed to be the hottest items in the store.

Pharmacies have also become gateways to more complicated testing. They now sell home collection kits for drug screening and sexually transmitted disease tests; the specimens are mailed to a reference lab for analysis. Clearly, much of our work is leaving the clinical laboratory.

The reasons behind the exodus are fairly obvious. Our the years, reagent test kits have become user friendly with easy-to-follow directions and methodologies. In addition, the miniaturization of analyzers has made clinical instruments less costly, easier to use, and more accurate.

From the perspective of physician and patient, self-testing offers several advantages. The first is patient convenience. For example, a diabetic can routinely check glucose levels in the comfort of home and avoid periodic trips to a hospital lab for blood drawing. Under certain circumstances, home testing can also lead to better medical care. To stay with the same example, by acquiring a "real time" glucose value rather than a "snapshot" value, the diabetic can more effectively control his or her disease.

Despite the advantages, many of us in the laboratory field have serious questions regarding self-testing. Our prime concern, of course, is quality. Most individuals performing tests at home have no training beyond reading the package insert. How frustrating it must be for college-educated technologists to be required to run positive and negative controls for the same pregnancy test that home users perform without QC.

Another major concern centers on specimen integrity, especially for the newer mail-in versions of over-the-counter tests. Sending specimens via mail without standard precautions or preparation may increase the chances for specimen degradation or mix-up of critically important values.

Cost is also a point of concern to us, on two fronts. First, home testing may prove more costly to the patient in terms of repeat testing or laboratory confirmation ordered by skeptical physicians. Second, it could lead to an increase in our labs' average cost per test if we lose many high-volume, low-cost, high-profit tests but must retain more costly and complex procedures.

I am somewhat surprised that the proliferation of self-testing has not met with much objection from the professional community. Laboratory societies should intensify their efforts to insure that home testing is limited to products of proved quality and reliability that clearly benefit the patient and have no potential for misuse.

Laboratory regulations should be amended to take into account the development of consumer test kits. Most states still operate under a double standard, requiring a physician's order for hospital or independent lab tests, but none for the same test self-ordered and performed and interpreted at home. If a test is available over the counter at the pharmacy, it should also be available over the counter in the laboratory. Lab professionals should be able to give advice and information to consumers, as pharmacists do.

Undoubtedly, we will see more testing outside the laboratory, in patients' homes and physicians' offices, and even in the work-place. Will this mean an end to the clinical laboratory? Not really, but there will be significant shifts in test mix. Simple tests may leave our laboratories, but we will develop other, more complex procedures at a faster pace. Emphasis will be placed on research and development to offset losses in routine volume. Many of us will also act as consultants to patients needing follow-up to home test results.

I think I can put the over-the-counter test situation in perspective by comparing it to computer use. Even with an abundance of personal computers, we still need mainframes at the office or in the factory for the big jobs. Think of your lab as a mainframe site performing the heavy-duty portion of laboratory medicine.
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Title Annotation:medical test kits for personal use won't replace medical labs
Author:Maratea, James M.
Publication:Medical Laboratory Observer
Date:Jan 1, 1987
Previous Article:A microcomputer test-costing program.
Next Article:CAP offers voluntary standards for nontraditional test sites.

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