Selection of healthy reference populations and definition of exclusion criteria for deriving 99th percentiles for high-sensitivity cardiac troponin assays used in clinical practice and research vary considerably in the literature. We discuss the Universal Sample Bank findings regarding their clinical implications: a) sex-specific 99th percentiles varied according to the statistical method and hs-cTn assay used, b) not all assays provided measurable concentrations for women to qualify as hs assays, and c) surrogate exclusion criteria used to define normality tended to lower 99th percentiles. Participants will learn that the decision concentrations used can affect diagnostics, risk-outcome assessments, and analytical characteristics.
This podcast will help you:
- Identify sex-specific 99th percentiles variations according to the statistical method and hs-cTn assay used.
- Describe why not all assays provided measurable concentrations for women to qualify as hs assays.
- Summarize how and when surrogate exclusion criteria should be used to define normality.
Fred S. Apple, PhD
Co-director Clinical and Forensic Toxicology Laboratory, Hennepin Healthcare/Hennepin County Medical Center, Minneapolis, Minnesota, USA
Professor, Laboratory Medicine and Pathology, University of Minnesota, USA
Frank Peacock, MD
Professor of Emergency Medicine and Vice Chair for Research, Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, USA