Best Practices for Maintaining Quality in Molecular Diagnostic Testing
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Summary
Molecular diagnostics has quickly become one of the leading global technologies for infectious disease testing. As such, clinicians and physicians rely on the results generated from these tests for accurate patient diagnoses. The field is constantly growing and evolving to meet the demands of infectious disease testing, but what remains constant is the importance for laboratories to maintain rigorous quality management practices, including quality control, to help ensure reliable test results.
With multiple regulatory and accreditation bodies like ISO, CLIA, CAP, and CLSI weighing in on good laboratory and quality practices, it can be challenging to implement a quality management system for your laboratory. This webinar will elucidate the current landscape of considerations for implementing a quality system in laboratories running molecular diagnostic assays, including quality controls.
At the end of this webinar, attendees will be able to:
1. Describe the relevant regulatory and quality system management principles as they apply to laboratories running molecular diagnostic tests.
2. Design appropriate quality control strategies for molecular/PCR-based testing methodologies.
3. Identify tools to help implement effective quality management of molecular diagnostic tests.
How can ZeptoMetrix help laboratories maintain quality in molecular diagnostic testing?
ZeptoMetrix quality controls offer a unique, full process testing solution for NAATs. Utilizing ZeptoMetrix® NATtrol™ Controls on a consistent basis helps to monitor testing performance and provides additional confidence in the quality and reliability of laboratory operations.
- Non-infectious and refrigerator stable
- Mimics a true clinical specimen
- Purified, intact whole organisms
- Full process controls to monitor extraction and amplification steps
- Available in different formats (single or multiple analytes)
- Can be used across various molecular testing platforms and assays
Speakers
Jack J. Zakowski, PhD, FAACC
Principal
IVD Consulting LLC
Jack Zakowski’s career in the IVD industry includes management roles in R&D, product development, technical support, and scientific affairs. He has spoken often on topics of interest to the clinical laboratory. He has been active with AACC in many capacities and twice sat on its board of directors.
At the Clinical and Laboratory Standards Institute (CLSI), Zakowski worked to advance healthcare through the development and use of voluntary consensus standards and guidelines within the healthcare community. He is a Past-President of CLSI.
In pursuit of the same values and goals, he was also recently chair of ISO Technical Committee 212 (TC212) on Clinical Laboratory Testing and IVD Test Systems, overseeing multiple project teams developing international standards. Zakowski is a principal in his IVD Consulting LLC practice.
Jessica VanAllen – PhD
Lead Technical Support Specialist
ZeptoMetrix
Jessica holds a bachelor’s degree in chemistry from Nazareth College and a doctorate in biochemistry from the University of Rochester. In 2012, Jessica joined ZeptoMetrix within the molecular department and worked as a senior molecular biologist, eventually becoming the manager of QC for the department. Over the years in these roles, she has focused on all aspects of NATtrol molecular quality control development including manufacturing, working with assay developers to design and develop new products, data collection and analysis, QC testing, and stability testing. More recently, she has taken a role as lead technical support specialist, incorporating her years of experience and expertise to better serve customers around the world.