Home Diagnostic Tests

HOME DIAGNOSTIC TESTS

Home diagnostic tests are devices available for purchase in pharmacies. They are designed to monitor chronic illnesses or test for symptoms, in a manner similar to tests done in a doctor's office or medical laboratory.
Examples of home diagnostic tests include:
- Blood glucose testing
- Blood/urine ketone testing
- Pregnancy tests
- Ovulation predictors
- Thermometers
- Blood pressure monitors
Specific products mentioned:
- TRUE Plus™
- OneTouch Verio® Family of Meters
The accuracy and the cognitive aspects of the measurement should be taken into account, such as matching test results to color charts within specific time frames to avoid misinterpretations.

Home diagnostic tests are not intended to replace professional healthcare.
These tests serve as supplementary tools alongside professional consultations.
It is essential that healthcare professionals remain involved with pre- and post-test counseling.
Patients may sometimes be instructed to adjust medication doses based on the results (e.g., insulin doses).
Caution: Patients should not change hypertension medication based solely on blood pressure readings collected at home.
Healthcare professionals can evaluate test results within the context of the patient’s overall health, providing interpretation, information, and support along with follow-up advice.

What is a medical device?
- Regulated by Health Canada.
- Defined broadly to encompass various products used in treatment, mitigation, diagnosis, or prevention of diseases or abnormal physical conditions.
Examples of medical devices include:
- Pacemakers
- Artificial heart valves
- Hip implants
- Medical laboratory diagnostic instruments
- Test kits for diagnosis, including contraceptive devices, condoms, BP monitors, and glucometers.
Medical devices (including diagnostic tests) must comply with the Canadian Medical Devices Regulations.

Medical devices are categorized by risk into four classes: Class I, II, III, and IV.
- Class I: Lowest potential risk; does not require a license for sale.
- Class II: Moderate risk; requires a manufacturer’s declaration of safety and effectiveness.
- Class III and IV: High risk; subject to in-depth regulatory scrutiny and require proper licensing before sale.
Devices must be purchased from reputable suppliers, with pharmacies being a primary source.
Caution is advised for online purchases, as jurisdiction may vary, leading to potential risks for the buyer.

Class I Examples: Surgical instruments, laboratory culture media.
Class II Examples: Contact lenses, pregnancy test kits, endoscopes, ultrasound scanners, blood pressure monitors.
Class III and IV Examples: Orthopedic implants, glucose monitors, dental implants, hemodialysis machines, cardiac pacemakers, angiography catheters, cranial shunts.

Class I devices do not require a device license; however, establishments producing or distributing these devices must be licensed.
For manufacturing and selling Class II, III, and IV devices, manufacturers must acquire a Health Canada license, with annual renewals required.

Proper quality assurance practices guarantee accurate results. Important practices include:
- Correct storage of devices
- Checking expiration dates
- Ensuring specimens are collected, stored, and shipped properly to mitigate inaccuracies.
Potential issues include:
- False negatives: Conditions present but tests show negative results.
- False positives: Conditions absent but tests show positive results.

Important considerations include:
- Proper arm cuff size (finger should fit under the cuff)
- Cuff placement (1 inch or 2.5cm above the elbow)
- Display readability
- Memory storage capability for readings

Recommendations include:
- Avoiding exercise, smoking, or caffeine 30 minutes prior to measurement.
- Resting seated for at least 5 minutes before taking measurements.
- Proper posture is essential: feet flat on the floor, arm at heart level, and back supported.
- Clothing should be removed from the upper arm, and no talking or distractions should occur during the measurement.

Home pregnancy tests detect the hormone HCG in urine, which is released after an egg has implanted in the uterus.
Testing options include:
- Testing urine stream directly
- Collecting urine in a container for testing
For best results, especially when testing early, it is recommended to use the first urine of the day.
Post-testing: A line or symbol typically indicates a positive result, often accompanied by a control indicator. New digital tests now provide a clear “pregnant” or “not pregnant” output.

Thermometers are medical devices used at home to measure body temperature, aiding in detecting fevers.
Various types of thermometers available:
- Rectal Thermometers: Most accurate and recommended for infants under 3 months (considered invasive).
- Oral Thermometers: Non-invasive, requiring placement under the tongue for 30 seconds to one minute.
- Oral Pacifier Thermometers: Require correct positioning in the mouth for 3 to 6 minutes.
- Ear (Tympanic) Thermometers: Use infrared technology; non-invasive and require only a few seconds. Not suitable for infants under three months due to ear canal size and the influence of ear wax as well as improper placement issues.
- Forehead Thermometers: Also use infrared technology and provide quick readings, generally easy to use.
- Axilla (Armpit) Thermometers: Least accurate but can be used for screening fevers, requiring placement for 30 seconds to one minute under the armpit.

Glucometers are devices that measure glucose concentration in the blood.
Useful for diabetes patients who may need to conduct tests multiple times a day.
Various types of glucometers exist to cater to individual patient needs.