Real-time PCR, also known as quantitative PCR (qPCR), is the gold-standard for sensitive, specific detection and quantification of nucleic acid targets. This technology allows for powerful assay design algorithms, optimized master mixes, intuitive data analysis software, and diverse applications in infectious disease testing, pharmacogenomic analysis, oncology testing, and more. The analytical validation (AV) of qPCR research assays can, however, be a complex and time-consuming task.
The need for analytical validation for qPCR and what it takes to execute
In this webinar, Victoria Quiett, Sr. Technical Project Manager at Thermo Fisher Scientific, explores the need for AV and dives into what it takes to complete AV for a qPCR workflow. Victoria shares her insights into the AV journey, focusing on the most accepted validation guidelines, challenges, and solutions for a successful AV.
The webinar begins with an overview of the validation requirements and test performance specifications set by some of the most prominent guiding agencies, as well as a suggested strategy for meeting requirements of multiple agencies.
Analytical validation consulting services through Thermo Fisher Scientific
The talk concludes with an overview of the AV consulting services provided by Thermo Fisher Scientific for the validation of qPCR-based assays and panels. With a track record of over 350 successful AV consulting service engagements completed, our team of seasoned consultants follow industry-quality standards and regulatory guidelines to help labs decide on the most suitable panel content and instrumentation for their workflow, including installation, qualification and training. The consulting service also addresses common struggles laboratories encounter with validation, including project management, obtaining control materials, data analysis, and documentation.
Key benefits of AV consulting services include:
- Acceleration of launch time – completion of validation process can be 75% faster on average*, compared a typical laboratory-managed AV
- A reduction in costs that add transparency to a workflow investment
- Facilitation of lab compliance with documentation templates
Be sure to watch this informative webinar to discover what it takes for a clinical laboratory to complete analytical validation for a qPCR workflow.
Explore additional educational content for molecular testing in clinical laboratories:
- Webinar series: Demystifying the Development and Implementation of Molecular Tests in a Clinical Laboratory
- Educational paper: An introduction to diagnostic testing in laboratories
*Each engagement is unique and average times may vary.
About the speaker
Victoria Quiett is a Senior Technical Project Manager at Thermo Fisher Scientific for the Global Compliance Professional Services team. In this role, she aids laboratories in the development and optimization of qPCR molecular applications for lab-developed tests. She specializes in designing and executing Analytical Validations on qPCR assays based on US regulatory organizations. Victoria began her career in the clinical laboratory industry in 2014 as a Genetic Laboratory Manager performing high complexity molecular diagnostic tests supporting Pharmacogenomic, hereditary cancer, and microbial panels adhering to various accrediting agencies.