How reliable are your blood test results?: Uncertainty Approach versus Error Approach

Paulo Pereira, R&D, Portuguese Institute of Blood and Transplantation, Lisbon, Portugal (pauloarpereira@outlook.com)

Accurate and reliable blood test results are critical for medical decision-making, yet the methods used to evaluate and ensure their reliability remain a topic of ongoing debate. This presentation explores the two primary approaches to assessing reliability: the Uncertainty Approach and the Error Approach. The Uncertainty Approach focuses on quantifying the range within which test results are expected to lie, emphasizing measurement traceability and the application of metrological principles. Conversely, the Error Approach prioritizes identifying, estimating, and controlling systematic and random errors affecting test outcomes. Through a comparative analysis of these approaches, we will address key questions: How do they differ in assessing reliability? What are their practical implications for clinical diagnostics? And which approach is more aligned with regulatory and quality assurance standards in medical laboratories? Case studies will illustrate how these methodologies impact the interpretation of blood test results, particularly in screening and diagnostic settings. Attendees will gain insights into the strengths and limitations of each approach, equipping them to critically evaluate and apply these concepts in the pursuit of enhanced analytical performance and patient safety.

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Short Biography of Presenting Author

Paulo Pereira, Ph.D. is a Postdoctoral Researcher and Head of Research & Development at the Portuguese Institute of Blood and Transplantation in Lisbon, Portugal. Dr. Pereira serves as an Expert on the In Vitro Diagnostic Medical Devices Panel at the European Medicines Agency (EMA) and is a Member of the Consensus Council of the Clinical and Laboratory Standards Institute (CLSI). He contributes as an advisor and co-author to CLSI protocols EP12, EP24, EP21, and EP46, as well as the Eurachem/CITAC protocol AQA:2021. A dedicated Quality Control Professor, Dr. Pereira has authored numerous peer-reviewed journal articles, book chapters, and books, establishing himself as a leader in his field.