All Masterclasses will include English subtitles.
Hs troponin assay QC challenges: impact of laboratory results on helping clinical decisions
Cardiac troponins (cTn) are the reference biomarker for cardiac injury. High-sensitive assays are able to detect low values of circulating cTn isoform (either I of T) in patients suspected of acute cardiac syndrome. Little is known about analytical variability and accuracy for these assays in low range values and 99th percentiles. We aim to present in this session the HS troponin assays quality control (QC) challenges for an optimized control of variability and accuracy in a laboratory routine practice. We also propose an analysis of the impact of analytical quality on laboratory results and clinical decision.
Camille Chenevier-Gobeaux, PharmD, PhD
Clinical biologist at the Department of Automated Biological Diagnostic of the Cochin Hospital, Paris, France Member of the French Society of Clinical Biology (SFBC)
Camille Chenevier-Gobeaux, PharmD, PhD, is a clinical biologist at the Department of Automated Biological Diagnostic of the Cochin Hospital (Assistance Publique des Hôpitaux de Paris, Paris, France) since 2013. She studied Clinical Biology at the Université de Paris and earned a PhD in Biochemistry at Université de Paris in 2008. Dr Chenevier-gobeaux's fields of expertise are immunoassays, point-of-care testing and emergency biomarkers. Previous research focused on the study of diagnostic and prognostic biomarkers to improve the management of patients with cardiovascular disease, sepsis, and oxidative stress. Dr Chenevier-Gobeaux is member of the French Society of Clinical Biology (SFBC). She also served as coordinator of the working groups “Use of troponins in Cardiological Emergency” (SFMU/SFC partnership, 2012) and “Troponin results turnaround time to the emergency room” (SFMU partnership, 2021).
Guillaume Lefèvre, PharmD, PhD
past head of the Biochemistry, Hormonology, and Therapeutic Monitoring Department at the Tenon Hospital, ,Paris, France member of (Société Française de Biologie Clinique (SFBC)
Guillaume Lefèvre, PharmD, PhD, is clinical chemist, past head of the Biochemistry, Hormonology, and Therapeutic Monitoring Department at the Tenon Hospital (Assistance Publique des Hôpitaux de Paris) Sorbonne Université, France from 2015 to 2022. He studied at the Université Paris Sud and graduated with a PharmD in biochemistry in 1981.
Dr Lefevre's fields of expertise are the diagnostic and prognostic values of biomarkers in oxidative stress, cardiovascular diseases and preeclampsia. As a member of SFBC (Société Française de Biologie Clinique), Dr Lefèvre has coordinated scientific groups on lipid peroxidation, STAT analysis, troponin and natriuretic peptides assays. Dr Lefèvre served also as an expert in different French commissions of Haute Autorité de la Santé (HAS) including myocardial infarction diagnostic recommendations, heart disease monitoring and atrial fibrillation care. He was also member of the IFCC “Committee on Clinical Applications of Cardiac Biomarkers (C-CB)” from 2017 to 2021.
Dr Lefèvre published 99 articles, reviews and editorials.
Guillaume Lefèvre is a frequent speaker at regional and international conferences on the topic of cardiac markers and related clinical diagnostics
How can you use QC to help with the Risk management requirements of ISO 15189:2022
ISO15189:2022 is patient and risk focused. This means labs need to find ways of evidencing how they are complying. Internal Quality Control (IQC) is an area that needs to be leveraged to help with both requirements. IQC is more than just confirming a patient result is within confidence limits to release, it can be used to predict trends, calculate measurement uncertainty as well as ensure that the labs can evidence clinical utilisation. The IQC should challenge the clinically relevant levels of assays and be as close as possible to a human matrix. This talk will look at how IQC can help with risk and patient care.
Dr David John Ricketts DBMS CSci FIBMS
Consultancy Ltd managing director, TC212 mirror committee chair
David chairs the TC212 mirror committee and is head of delegation for the UK on the international TC212 committee. David has experience in writing standards and was the project lead on ISO22870, on the drafting team of the new ISO15189 as well as being involved in many other standards including ISO22367. David has written many expert commentaries for British Standards. David is the managing director of his own Consultancy company, speaking on a wide variety of laboratory related subjects.