CLN Daily
Cardiac troponin I (cTnI) is considered one of the most critical measurements in laboratory medicine and patient care. Despite its widespread clinical utility, the assay has several limitations that lab professionals and clinicians should keep in mind. In the Tuesday afternoon session, “Cardiac troponin I utilization: Impactful consequences from lacking standardization and harmonization,” four expert speakers will examine how these limitations affect clinical practice and review ongoing efforts to address them.
“The fact that cTnI is neither standardized nor harmonized can have a detrimental impact on patient care,” said session moderator Robert Christenson, PhD, DABCC, FADLM, FACC. To help ADLM 2026 attendees better understand this challenge, the presenters will explore key concepts, including commutability, traceability, standardization, harmonization, selectivity, and non-selectivity, as they relate to high sensitivity cTnI (hs-cTnI) testing.
Although hs-cTnI assays have achieved alignment in critical analytical performance characteristics, such as imprecision at the 99th percentile and assay sensitivity, the measurement values can vary substantially due to selectivity, commutability, and other important properties.
These challenges are becoming increasingly relevant as hs-cTnI testing expands beyond the central laboratory. With the emergence of point-of-care hs-cTnI assays that may be used alongside established lab-based platforms, understanding the sources and implications of assay variability will be essential for both laboratorians and clinicians.
One promising strategy for assay harmonization is the development of a universal reference material that allows manufacturers to calibrate their tests against a common standard. Until recently, however, no suitable reference material existed for cTnI, leaving a critical unmet need in the field. This session will highlight how that is finally changing.
Claudia Swart, PhD, will open the session by describing the design and production of a new human plasma-based reference material called reference material 8121 (RM 8121), which is intended to improve the comparability among hs-cTnI assays. The material was developed through a collaboration between the International Federation of Clinical Chemistry (IFCC) and the National Institute of Standards and Technology (NIST).
Building on this foundation, Christenson will review recent commutability studies performed using various FDA-cleared hs-cTnI assays currently used in clinical laboratories.
Finally, two speakers from NIST will discuss harmonization. David Newton, PhD, will examine the suitability of RM 8121 for standardizing FDA-cleared hs-cTn measurements, while Mark Lowenthal, PhD, will cover how it can be applied to harmonize assay calibration, improve comparability across platforms, and ultimately support more consistent clinical decision-making.
Attendees will learn how the introduction of this new reference material, combined with a deeper understanding of assay limitations and performance characteristics, has the potential to make the complex hs-cTnI testing landscape much simpler.