Spectrum MDX strives to provide the highest quality diagnostic screening devices with value-added solutions to help enhance patient treatment and care. All products we offer are Health Canada licensed and FDA 510k cleared. We partner with reputable manufacturers that are ISO 13485 certified, guaranteeing quality products with accurate results.
The Significance & Importance of Health Canada Licensing
Any product that is designed for use on humans requires special licensing from Health Canada. Rapid drug screening products are classified as either Class II or III medical devices, and specific regulations and guidelines apply for each license category to ensure patient safety.
Health Canada and the FDA in the United States work closely together to manage the safety and efficacy of all medical devices (ie: rapid POCT devices).
Why does Health Canada Matter?
According to Canada.ca and the Government of Canada, Health Canada’s role is to help Canadians maintain and improve their health. While the provinces and territories are responsible for delivering healthcare to the majority of Canadians, the federal government also has a number of key roles and responsibilities in areas that affect health and healthcare”2
It is highly recommended that proper due diligence is taken when purchasing these devices, as this could pose a tremendous liability for your organization. The main purpose of maintaining compliance is to ensure patient safety.
Manufacturers and suppliers MUST have standard operating procedures (SOP’s) in place to resolve any issues affecting the patient’s health (as a result of using these devices) and the integrity of the product (e.g. defective product, quality control, product recalls etc…).
Rapid POCT devices are being used to screen patients to ultimately enhance their treatment, so it’s imperative that these devices (and companies selling them) comply with all Health Canada regulations. These regulations are in place to protect the health and safety of Canadians.
We wouldn’t consider using a pharmaceutical drug without FDA or Health Canada approval, so why is a drug test any different?
Our screening solutions have been designed to meet industry trends and to help our customers optimize their screening programs. We offer a wide range of quality brands and products for accurate, reliable results. Our diverse menu of rapid diagnostic test kits include:
Urine Drug Screening (POCT)
Our point of care tests (POCT) can rapidly detect the presence of prescription medications and illegal substances in urine within minutes. We offer several high quality, accurate solutions including multi panel drug test, cassette and split specimen cups that may be fully customized to suit your needs. Several different tests and formats are available to accommodate any screening program.
We are pleased to announce that Spectrum MDX recently launched our own brand of rapid POCT screening devices for substance abuse detection called ‘SpecCheck’. Our brand is synonymous with high quality, accurate products designed to enhance patient treatment. We strive for continuous innovation and improvement, making us the leader and preferred choice for all point of care needs.
Oral Fluid Drug Screening (POCT)
Oral fluid drug screening provides a reliable preliminary result and is ideal for use as a secondary screening tool in many programs. These tests are non-invasive and may be used to determine recent drug use (as early as 5-10 minutes). Several configurations are available to suit your screening requirements.
We offer a number of solutions for rapid alcohol detection including breath, urine and saliva screening devices.
Rapid alcohol screening devices may be used to determine whether a person is above or below a 0.02% screening cut-off level for alcohol. Our solutions also include various breathalyzers (Alcohol Screening Devices (ASDs) and Evidential Breath Testers (EBTs)) for non-DOT and DOT analysis.
Adulteration test strips (Specimen Validity Tests) are an efficient and cost-effective way of determining if a urine specimen has been adulterated or tampered with by the donor or patient. Various external agents may be used to alter the constituents of the urine, thereby eliciting false negative drug test results. It is recommended that a specimen be pre-screened to avoid this issue. The most common adulteration test includes a panel that can detect pH, Creatinine, Specific Gravity, Nitrite and Oxidants.
Nicotine (Cotinine) Screening
Rapid screening devices are available to detect the presence of Cotinine (Nicotine) in urine at either 100 ng/mL or 200 ng/mL.
This product is typically used in clinical research, smoking cessation programs, health or life insurance application processes and more.
Women’s Health Screening
We offer a number of rapid, qualitative tests in our fertility product menu including hCG (human chorionic gonadotropin), LH (ovulation) and FSH (menopause) in human urine/serum specimens. Tests are available in cassette, mid-stream or dip formats and are ideal for professional clinical use.
Certification Training (DOT & non-DOT):
We also offer value-added services to help enhance your screening procedures. Our web-based DOT-Regulated & Non-Regulated Drug Collector Training and Certification programs comply with all corporate drug screening policies to help you access superior training at lower costs. This can help businesses maximize efficiency and implement best practices for your drug and alcohol screening programs. Courses are thorough, covering all aspects of DOT rules and regulations, and are fully DOT compliant.
- DOT Certified Professional Specimen Collector (CPSC)
- Breath Alcohol Technician (BAT)
- Designated Employer Representative (DER)
- Screening Test Technician (STT)
- Supervisor Awareness Training (SAT)
Our highly accurate point of care rapid tests provide a cost-effective solution for the detection of parthenogenic micro-organisms such as bacteria, parasites, viruses and fungi.
These easy to use tests acquire specimens to detect bacteria in urine, blood, sputum, cerebrospinal fluid and more.
We strive to provide the highest quality diagnostic screening devices with value added solutions, and our portfolio includes over 50 products to help enhance patient treatment and care.