A-013 Creation of a Commutable Cardiac Troponin I Reference Material Coined 8121 by the National Institute for Science and Technology and the IFCC Workgroup for Cardiac Troponin I Standardization

Abstract

Abstract Background Harmonizing cardiac troponin I (cTnI) is needed because this biomarker is central to defining cardiac injury, and is essential for diagnosis and management of myocardial infarction (MI) and other cardiac conditions. cTnI measurements have evolved through several generations; state-of-the-art assays are coined “high-sensitivity cTnI” tests. We describe development and availability of commutable Reference Material (RM)8121, designed and created by the National institute of Standards and Technology (NIST) and the IFCC workgroup for cTnI standardization for availability to stakeholders. Methods RM8121 is a lithium heparinized series of four Levels of increasing cTnI concentration coined Levels A (lowest) to D (highest). Each RM8121 concentration resulted from combining an elevated cTnI pool from sample collections from 58 MI patients with a blending pool comprised of low cTnI samples from 15 healthy females and 15 males, all <40-years old. All subjects donating collections were consented under an IRB-approved protocol at the University of Maryland. All enrolled subjects were confirmed negative for hepatitis A, B, C and HIV infection. Hemolyzed, lipemic and icteric samples were excluded from pooling. RM8121’s Levels A–D were homogenized, and 0.71 mL aliquots pipetted into 2-mL vials. hs-cTnI concentrations were measured at critical points throughout the recruitment, sample collection, blending and final aliquoting processes using the Atellica® IM TnIH assay (Siemens Healthineers). Results Approximately 3000 units of RM8121 are available. The table displays the hs-cTnI concentrations of the blending and high pools. Concentrations of RM8121 Levels A and B were designed to bracket the female and male 99th percentile URLs, with RM8121 Levels C and D in the range of 9-fold and 100-fold greater than the female 99th URL, respectively. Conclusion Values for FDA cleared hs-cTnI assays will be assigned for RM8121. Availability of this commutable cTnI RM is intended to assist in harmonizing current and future hs-cTnI assays.