All Masterclasses will include English subtitles.
CMV viral load monitoring : do results expressed in international units guarantee inter-laboratory comparability? Lessons from a multicentre study
Cytomegalovirus viral load quantification is a key marker in the setting of transplantation. In many instances, patients are not necessarily followed in a unique center after their graft and standardization of viral load measurement between laboratories becomes an important clinical issue as it determines treatment initiation. We conducted a multicenter blinded study involving 7 laboratories using different techniques for CMV viral load measurement. We investigated how we could address commutability between laboratories to obtain comparable results between them. Running identical standardized material calibrated against IU/mL might be a solution but is it enough? Based on our data, we will provide some thoughts about the best strategies to limit interlaboratory discrepancies.
Prof. Vincent Thibault PharmD, PhD
Director of the Virology laboratory in Rennes University hospital, France.
Prof. Vincent Thibault is director of the Virology laboratory in Rennes University hospital (France). His work is mainly devoted to the diagnosis and monitoring of viral infections using current serological and molecular assays. His research focuses mostly on hepatitis viruses and the development of new biomarkers in clinical virology. He graduated in medical biology from Paris University in 1991 and completed a PhD on cytokine delivery using recombinant adenovirus vectors at McMaster University in Hamilton (Canada). He is involved in many clinical collaborative works with a special emphasis on the characterization of hepatitis B virus viral particles and the impact of human papillomavirus co-infection by different genotypes. Prof Thibault is also involved in several activities within the ANRS-MIE (The French national agency for research on AIDS, viral hepatitis and emerging infectious diseases) for the optimization and standardization of viral infection diagnosis and monitoring.
The Impact of IVDR on Molecular testing for Infectious diseases
“The European regulation on in vitro diagnostics (IVDR) has been in force since May 2022 and will be progressively rolled out further in the next few years. This regulation has impact on manufacturers but also on (hospital) laboratories, in particular in Molecular laboratories, that develop in vitro diagnostics assays “in-house”. This presentation will focus on the implementation of the IVDR and the challenges hospitals may face in this implementation concerning in house developed assays. Although not providing clear-cut answers and solutions to these challenges, this presentation provokes thoughts and discussion that hopefully can lead to best-practices.
Dr. Richard Molenkamp Ph.D.
Head of molecular diagnostics at Dept. Viroscience, ErasmusMC, Rotterdam, the Netherlands
D r. Richard Molenkamp has a long history of working in Virology. He defended his Ph.D. thesis on Corona- and Arteriviruses in 2000 at Leiden University, The Netherlands. Subsequently he worked as post-doctoral fellow on Yellow Fever Virus, Lassa virus and Hepatitis C Virus. In 2005 he started as molecular biologist in clinical virology at the Academic Medical Center, Amsterdam where he became head of molecular diagnostics in 2007. Here he was responsible for assay development, validation and implementation as well as routine detection and genotyping of clinically relevant viruses. In addition he was involved in several research projects including on respiratory viruses and Hepatitis C Virus. He has been board member of the Dutch working group for molecular diagnostics of infectious diseases. He has been an technical assessor ISO15189 for the Dutch accreditation council and educator of Medical Molecular Microbiologists in training. From April 2018 he moved to the ErasmusMC, department of Viroscience where he is heading the molecular diagnostics. He is alternate for the national and WHO reference centers and focal point for WHO and ECDC. Dr. Molenkamp has a strong interest in emerging viruses in general and arboviruses specifically, molecular epidemiology, quality management and innovative technologies.