Diagnostic Laboratory Quality Assurance: Proficiency Testing
Did you know that laboratories (and the technicians that work there) that test your blood (and other samples) have to pass a proficiency test three times every year? Microbix is a key player in that market.
Currently, there are over 150,000 registered laboratory facilities in North America offering diagnostic services. They range in size and scope from a physician’s office testing for seasonal flu to the largest hospitals and clinical laboratories diagnosing rare and complex diseases. To ensure doctors and patients can rely on a consistent test quality from these labs, a system of accreditation and oversight has been established.
In 1988 the US Congress passed the Clinical Laboratory Improvement Act (CLIA), which set standards for facilities performing laboratory testing on human specimens for health assessment, diagnosis, prevention and treatment. Laboratories are required to maintain high standards of accuracy to retain their license to operate.
Proficiency Testing (PT), formally known as External Quality Assessment, measures laboratory testing competency. A licensed Proficiency Testing supplier provides the commercial clinical laboratories with ‘blind’ samples; the laboratories then perform the standard test to determine what disease state a sample represents. A wide range of disease states is represented in the samples provided. The laboratory submits its results to the proficiency authority for verification, which uses un-blinded sample codes for comparison. Results are summarized and published. Laboratories correctly identifying all sample disease states pass the Proficiency Examination and have their operating license renewed for another year. Those not performing to standard are subject to review and inspection, and in some cases have their license suspended until they can demonstrate they meet the proficiency standard. This oversight process ensures laboratories deliver timely, accurate results to real patients.
Because of Microbix’ highly respected reputation for virology products, the Company has established relationships with all major PT Providers. We prepare samples on their behalf for a wide range of respiratory, gastrointestinal and sexually transmitted diseases. Microbix shipped over 75,000 samples to laboratories globally in 2015. Since entering this market in 2010 we have become the largest provider of virus samples in the world. Adding to our sample portfolio each year, we expanded this product line in 2016 to include PT samples for the Molecular Diagnostics* market. We are well positioned to keep pace with the rapidly changing technological landscape while increasing the sensitivity and accuracy required for new generational tools in the diagnostics market.
Traditional immunodiagnostic assays rely on a complex antibody/antigen reaction to identify a current or previous infection. These assays may occasionally have lower sensitivity (ability of a test to correctly identify patients with the disease) and clinical specificity (ability of a test to correctly identify patients without the disease). *Molecular Diagnostics (MDx) technology, which Microbix’ products now support, relies on the analysis of nucleic acid (DNA or RNA) of a virus for a currently active infection, allowing for rapid diagnosis with very high clinical sensitivity and specificity.