New: Novel immunoassays targeting different forms of human cardiac troponin

05.06.2025

The article, titled “Design and Analytical Evaluation of Novel Cardiac Troponin Assays Targeting Multiple Forms of the Cardiac Troponin I–Cardiac Troponin T–Troponin C Complex and Fragmentation Forms,” presents a comprehensive analytical evaluation of novel cardiac troponin assays designed by Hytest scientists in collaboration with Dr. Zhenlu Zhang (Wuhan Asia Heart Hospital), Dr. Fred Apple (Hennepin Healthcare/Hennepin County Medical Center), and Dr. Yi Zhang (Mindray Bio-Medical Electronics Co.).   

Current studies suggest that cardiac troponin (cTn) forms in the circulation may vary in different clinical scenarios. To further explore the presence of different cTn in blood of patients, several new immunochemical assays targeting different components of troponin complex were designed and evaluated. Analytical performance and reference intervals of two immunoassays specific to troponin complex (Long-T ITC complex assay that was specific to the ITC that comprised cTnT without cleavage at the C-terminal amino acids residue 189–223 and hs-Total ITC complex assay that recognized both the long- cTnT ITC complex and short-cTnT ITC complex), hs-TnI and hsTnT assays as well as a stability of different cTn forms were investigated.    

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  * Hytest recombinant human cardiac ITC was used as the antigen for value assignment of immunoassay specific to the long-T ITC complex assay and hs-total ITC complex assay. For the hs-cTnI assay, cardiac troponin I-C complex was used as the calibrator, and for the hs-cTnT assay, cardiac troponin ITC complex was used as calibrator.

Both immunoassays specific to ITC demonstrated excellent analytical sensitivity, precision, and specificity. The 99th percentile upper reference limits (URLs) were determined separately for males and females, in accordance with current clinical recommendations. The hs-total ITC complex and hs-cTnT assays showed measurable concentrations above the limit of detection (LoD) in more than 50% of healthy individuals, meeting the requirements for high-sensitivity performance.

The study concludes that these cTn assays effectively detect the major circulating forms of cTn with high sensitivity, precision, and specificity. These findings support their application in monitoring both intact troponin complexes and fragmented forms during myocardial injury, offering valuable tools to improve diagnostic accuracy in clinical cardiology.

To learn how Hytest cTn products perform, click here Cardiac Markers brochure and  Troponins Booklet. 



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