All Masterclasses will include English subtitles.
Utilization of Unity data management solutions for assessment of quality control of viral load assays based on clinical decision-making needs
Viral load assays play an important role in diagnosis and management of a variety of infections and require robust quality programs to ensure accurate result reporting. Acceptability of results necessitates utilization of quality control rules (Westgard rules) that balance the benefit of error detection with the cost of false rejection.
This seminar will discuss how to determine allowable error for a test so that clinically relevant changes in viral load can be identified and will also demonstrate how to use Bio-Rad Laboratories’ Unity QC data management solutions to choose and implement QC rules that strike the right balance between error detection and false rejection.
The challenges around commutability between quantitative real-time PCR assays: the example of CMV
Immunosuppressed patients who have undergone solid organ or stem cell transplants require quantitative monitoring of different viruses over time (viral load testing), and for logistical reasons may have this testing performed by different laboratories. As clinical laboratories may utilize different platforms and/or different protocols, this may lead to results that cannot be compared from one laboratory to another (i.e., are not commutable).
The aim of this presentation is to highlight differences between assays that may contribute to the challenge of establishing commutability and opens the discussion around potential solutions that may aid in recognizing and understanding the sources of variations between assays.
Speakers
Utilization of Unity data management solutions for assessment of quality control of viral load assays based on clinical decision-making needs
Duane W. Newton, PhD, D(ABMM), FIDSA,
Bio-Rad Laboratories
Duane Newton, Ph.D., D(ABMM) is currently a Scientific Affairs Manager of Quality Systems at Bio-Rad Laboratories. Prior to joining Bio-Rad, Dr. Newton enjoyed a 20+ year career as a clinical microbiology laboratory director in both public health and academic medical center laboratories. Most recently, Dr. Newton served as the Director of the Clinical Microbiology Laboratory, and Associate Director of Clinical Pathology at Michigan Medicine, Ann Arbor, MI, and also held faculty appointments in the Medical School and School of Public Health at the University of Michigan. Dr. Newton’s interests and expertise is in developing and executing strategies to optimize the impact of laboratory diagnostics for the improvement of patient care.
The challenges around commutability between quantitative real-time PCR assays: the example of CMV
David Gauthier, MA,
MA – Senior Product Manager at Bio-Rad Laboratories Quality Systems
David Gauthier is currently a Global Product Manager for Bio-Rad’s Quality Control division in Irvine, California. He is responsible for the Exact Diagnostics portfolio of molecular controls, standards and verification panels.
David Gauthier has over 10 years of experience in IVD companies in the field of molecular diagnostic testing. His interest and expertise are in developing new quality controls and standard products for Molecular laboratories to ensure the quality of patient results.