It's Your Health
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A growing number of Canadians are using medical test kits in their homes to diagnose or monitor certain health conditions. These test kits are considered to be medical devices. Like all medical devices, they provide potential benefits, but they can also present risks.
Advances in technology have made it possible for Canadians to self test for a variety of medical conditions. Medical test kits for home use can help do the following:
Some of the benefits of using home test kits are obvious. They can help you take an active role in monitoring and even improving your health. They offer privacy because the tests are conducted at home. In many cases, the tests also provide quick results, sometimes in a matter of minutes.
But health and sickness are very complex issues. It is important to realize that do-it-yourself medical tests are not a replacement for professional health care. Medical kits for self-testing are best used when they are part of a comprehensive program that is supervised by a health care professional.
Home-use test kits are medical devices, and medical devices must be licensed by Health Canada before companies can sell them in Canada. The licence from Health Canada provides the assurance that the product is safe and effective when used as directed. It is important to be sure that the product being used is licensed by Health Canada. See the Need More Info? section for more on this.
Some companies advertise and sell test kits over the Internet and/or by mail order. In some cases, the products they offer may not be licensed for sale in Canada. If you send money to companies that are not reliable and reputable, you may end up getting a defective product, or no product at all. A defective test kit may indicate a health condition when none is present. Worse, it may fail to identify a condition you do have.
Legitimate companies will market their products using legal distribution channels. An unlicensed test kit (bought from either a foreign or a Canadian supplier) very likely does not meet Canadian requirements of safety and effectiveness.
Even when test kits have been licensed by Health Canada, the results may not be 100% accurate. Faulty results can happen if all of the directions for storing and using the test kits are not followed. Sometimes people try to save money by doing things like cutting glucose test strips in half so they will last twice as long, or trying to "mix and match" parts from different kits. Tampering with the contents of a test kit means you are less likely to end up with accurate results.
If you don't consult a qualified health care professional, there is also a significant chance that you may interpret test results incorrectly and/or decide to change your treatment or lifestyle unnecessarily. Interpreting test results should always be part of a comprehensive health assessment.
The following steps will help to minimize the risks associated with home-use medical tests:
Remember that do-it-yourself tests are not a replacement for a qualified health care professional. These tests are best used as part of an overall approach to health that is supervised by a qualified health care professional.
When buying a test:
Read and follow the directions for storing the test kit. If you don't store the test kit properly, it could affect the accuracy of the test results.
Before using the test:
After conducting the test:
Medical devices, including test kits for home use, must be licensed by Health Canada before companies are allowed to import and sell them in this country. The Medical Devices Regulations require that all medical devices imported and sold in Canada be safe, effective, and of quality manufacture. This is achieved through both a pre-market review of medical devices (before licensing), and post-market surveillance of problems and adverse events (after licensing).
To report problems with medical devices, visit Health Canada's Health Product and Food Branch Inspectorate website.
For more information visit the following web pages:
For safety information about food, health and consumer products, visit theHealthy Canadians website
For more articles on health and safety issues, go to the It's Your Health web section.
You can also call toll free at 1-866-225-0709 or TTY at 1-800-267-1245*.
Updated: May 2011
Original: September 2005
ęHer Majesty the Queen in Right of Canada, represented by the Minister of Health, 2005