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Patient Self-Testing:

Tap Into Stong Consumer Trend To "Grow" Your POL Business
(Part 1 of a 2-part series)

by Dr. Sheila Dunn

Reprinted with Permission from Washington G-2 Reports, Physician Office Testing, February 1999

Americans are increasingly performing diagnostic tests in the privacy of their own homes. In the last 15 years, we've seen an explosion of home diagnostic kits being marketed in pharmacies, grocery story chains, television spots, newspaper ads, and even on billboards.

These kits have enabled consumers to test for pregnancy, blood pressure, blood glucose, cholesterol, cancer, and HIV. And there's a lot more in the pipeline: heart attack monitors, ulcer and gastritis tests, and sexually transmitted disease tests, among others.

Predictions are that patient self-testing will continue to skyrocket because of rising consumer expectations, technological innovations, and managed care coverage limitations. Significantly, a large aging population--the "baby-boomers"--is more involved than any previous generation in managing their own health. Already, they've made it a multi-billion dollar market, and they're willing to pay for much of it out-of-pocket.

In this surge of consumer activism in healthcare, the physician office laboratory is uniquely positioned to run a Patient Self-Testing Program that can expand quality testing services and follow-up and ultimately improve patient outcomes. In this two-part article, we'll examine how to develop and administer such a patient-friendly program that will markedly distinguish you from your competition.

Current Universe Of Home Tests
Consumers can buy tests ranging from clinical laboratory tests to physiological tests for a variety of purposes, from skin cancer detection to monitoring anti-coagulant therapy (Figure 1).

Several tests, such as those which detect antibody to HIV, consist of a specimen collection unit only; tests on the specimen are performed in a referral laboratory. Other home tests require physician intervention to act on the results. Still other tests allow patients to self-manage their conditions based on results from tests performed by the patient, such as glucose testing for diabetes.

Thus, the various types of home-based testing offer consumers a range of participation and independence from the physician from high to moderate to low, as illustrated below:

  • High -- Patient Self-Management. Patient performs the test and can adjust therapy independent of the physician.
  • Moderate -- Patient Self-Testing. Patient performs the test and relays results to the physician who must follow up on results by adjusting therapy, scheduling an appointment, etc.
  • Moderate -- Patient Specimen Collection. Patient collects urine, saliva, blood, etc., and mails the specimen to a testing facility. Consultation is available via telephone. The laboratory does not share the results with the patient's physician.
  • Moderate -- Patient Self-Referral (also known as direct access testing and authorized within limits by certain states). Patient has tests performed in a pharmacy or retail laboratory without a physician's order. Results are not shared with the physician.
  • Low -- Home Health Testing. Patient has the testing performed at home by home health personnel. Results become part of the patient's chart and are acted on immediately.

All laboratory tests approved for home use are waived under federal regulations governing CLIA (Clinical Laboratory Improvement Amendments). More CLIA-waived tests may someday be approved for home use. Among these: erythrocyte sedimentation rate; hemoglobin instrument; microhematocrit test; Helicobacter pylori kit; Streptococcus pyogenes (Group A Strep) kit; gastric occult blood card test; glycosylated hemoglobin (A1c) instrument; mononucleosis test kit; nicotine urine test; and vaginal pH test.

Situations Suited To Home Testing
For patients with certain conditions, home testing is particularly applicable. For example:

  • Patients who must take warfarin (Coumadin) or heparin therapy and need to have appropriate drug levels established; are high risk; newly anti-coagulated patients whose drug levels are not yet stable; and those who are taking warfarin for a limited period of time, such as a few weeks of prophylaxis following hospital discharge for orthopedic surgery.
  • Patients who are starting or stopping a drug which interferes with anti-coagulation therapy.
  • Patients who self-manage diabetes.
  • Patients who have a high-risk condition that requires frequent monitoring.
  • Patients with poor venous access. Point-of-care testing that uses whole blood fingerstick samples is more comfortable for these patients.
  • Patients who do not have easy access to laboratory services but require frequent testing. Many seniors relocate to warmer climates in the winter months or travel extensively throughout the year and find home testing convenient for their mobile lifestyle.
  • Patients who meet one or more of the above conditions, are capable of performing a test themselves, and can afford to purchase the test kit.

Test kits and instruments designed for home use are relatively simple to master and provide reliable results when used correctly. An ideal patient who is motivated to test, is reliable, and can master the testing process will provide his or her physician with dependable data. But most patients are not ideal. That's why a Patient Self-Testing Program you develop and administer must include initial training of both patients and the program's personnel, as well as periodic competence evaluation (more about this next month).

Most patient self-testing instruments today contain built-in data storage, but most designs rely on external programs to receive and manipulate the data. Some tests are performed without use of an instrument, such as diagnostic test kits, and in these instances the consumer must be relied on to communicate the results. More development is needed in automatic data transmission, especially for testing requiring close professional supervision.

Future Of Patient Self-Testing
Anticipating growth in the home testing market, manufacturers are devoting major resources to development of non-invasive tests. Efforts to find less invasive glucose tests accelerated with reports that glucose levels in interstitial fluid (just below the skin) are proportional to blood glucose concentrations. Some devices in development tap "minimally invasive" processes to extract small amounts of this fluid for analysis instead of blood.

The fact that patients dislike needles is well known, yet the extent to which it compromises care and undermines public health has not been determined. It is well known that diabetics don't monitor their blood glucose level or take their insulin as often as they should because of this dislike and discomfort. Now it appears that a virtually needle-less future may be plausible.

In the next decade, expect to see non-invasive tests such as wristwatch-style devices that monitor blood glucose levels and sound an alarm when intervention is needed. Imagine a patch that draws out interstitial fluid slowly, or a laser beam that creates a tiny port from which fluid is extracted. Other research focuses on electromagnetic radiation to measure blood glucose in such areas as the eye, which is a painless process.

Couple this with a non-invasive drug delivery system, such as a skin patch or a painless microneedle which blasts drugs in powder form through the skin at high speed. Or go one step farther and imagine an implantable microchip that performs diagnostic tests, delivers immediate results both to the patient and to a physician at a remote terminal, and provides time-release medication. The physician (or patient, in some circumstances) would program a dosage adjustment based on the test result.

Expect to see, in the near future, technology that integrates training capabilities within analyzers designed for home use, even small hand-held devices. The further miniaturization of electronics and optics at both the detector stage and the data processing stage will enable even a greater degree of portability than presently available.

Despite obstacles, the future of home testing is bright. In the next decade, expect point-of-care testing networks to extend from the home to the most sophisticated acute care settings. Put your POL at the forefront of this movement. Catch the wave! Next month: Designing and running a POL Patient Self-Testing Program.

>> Go to Part 2: Patient Self-Testing: Putting Together A Program Tuned To Patient Staff Needs


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Figure 1:
(Return to text.)

Home Tests
 Analyte/Test  Device/Specimen
 Alcohol  Breath
 Body fat  Bioimpedance Monitor
 Blood, occult  Kit for collecting stool samples
 Blood pressure monitoring  Instrument with Digital Display
 Cholesterol  Card Type Test Kits/whole blood
 Drugs of abuse  Kit/urine
 Ear infection  Tympanometer
 Fructosamine  Instrument/whole blood
 Glucose  Dip strip/urine, Instrument/whole blood
 Heart rate, pulse, oxygen use  Instrument, Pulse oximeters
 hCG  Kit/urine
 HIV  Kit for collecting blood sample
 Ketones  Dip strip/urine
 Leutinizing hormone (LH)  Kit/urine
 Lung function  Peak Flow Meter/Spirometer
 Protein  Dip strip/urine
 Prothrombin time (PT)  Instrument/whole blood
 Urinary tract infection
(leukocyte esterase and nitrite)
 Dip strip/urine

Note: Self-tests which consist mainly of patient education materials, such as vision screening charts and skin growth monitoring systems, are not included in this figure.

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