Healthcare costs for American families in 2012 exceeded $20,000 for the first time according to the annual Milliman Medical index (MMI) which measures the total cost of healthcare for a typical family of four. The 2012 MMI is $20,728, an increase of $1,335 or 6.9% over 2011.This means that for many people, their health care costs are higher than their annual mortgage payments!
As patients become more empowered and engaged they are looking on their own for ways to reduce some of these costs, particularly office visits and lab fees. As a result, many turn to home testing.
Home test kits are available to detect ailments from high cholesterol to cancer and HIV. Using a few, drops of blood, a urine sample, or a snippet of a child’s hair, home tests now provide results related to such serious issues as colon cancer, cardiovascular disease and whether or not your child may be using illicit drugs.
For years, pregnancy tests and ovulation predictors dominated the home test kit market. The fact that they produce speedy results and early confirmation present an opportunity for patients and health-care providers to discuss options, and for patients to seek early education about pregnancy and birth.
Kidney disease, one of the most devastating complications of diabetes, but detectable and treatable in its earliest stages, can also benefit from a home test kit.The kit enables diabetics to test for glucose and even small amounts of protein in their urine–an early sign of kidney dysfunction. It is safe as long as the results are communicated to the patient’s physician and together the patient and doctor map out a treatment plan.
On the other hand, home tests raise red flags among health care professionals because:
(1) They fear that a patient misunderstanding and misinterpreting test results could lead to serious, potentially fatal health issues.
(2) These tests frequently present false positives or negatives which cause misunderstanding, trauma and confusion that requires a clinician’s input to straighten out.
(3) Since most patients are not medically trained, they may not be able to follow the instructions which can be quite obtuse.
(4) There is also the issue of how to insure proper collection, storage and shipment of specimens from home tests, so they are usable for an accurate read. Samples held too long, or subjected to severe temperature changes could generate inaccurate results. Urine samples taken too early or too late in the day,or foods eaten that mimic the metabolites being measured also can produce inaccurate readings.
Steven Gutman, M.D., Director of the Food and Drug Administration’s Division of Clinical Laboratory Devices warns that “consumers need to be wary about buying and using kits on their own. People need to carefully read the test-kit labeling and instructions and pay heed to the warnings about the product,” he says.
The FDA recently tested a number of unapproved home HIV test kits sold on the Internet that were confiscated during a criminal investigation.None produced accurate results. The FDA’s Center for Biologics Evaluation and Research, which reviews all blood-related products, continues to investigate firms and people involved in the illegal sale of unapproved HIV home test kits in the United States.
There are a number of other bogus home tests not cleared by the FDA that can be inconsistent and inaccurate and will lead patients to draw false conclusions about their health.
Home test kits are not meant to replace the office visit.In spite of the fact that we encourage people to become e-patients who take charge and assume responsibility for their health care, it is also critically important that e-patients realize the pitfalls, issues, and dangers of home testing without consultation with a clinician who can evaluate results within the context of the whole health picture, not just one test. Additionally, smart patients know that they should use only those home test kits that have received FDA approval.
For more information on where to buy valid home tests or how to manage results, check the FDA website at www.fda.gov/oc/buyonline/