Key result
The upper 99th percentile reference limits for the high-sensitivity cardiac troponin-T assay were established at 16.2 ng/L in healthy non-competition horses and 23.2 ng/L in racing Thoroughbreds.
Observational (n=303)
The Roche high-sensitivity cardiac troponin-T assay is analytically valid for use in horses and has established reference intervals for clinical and sports medicine applications.
Supports hs-cTnT use in equine practice; leaves open prospective outcome validation in horses.
BACKGROUND: Cardiac troponin-I assays have been validated in horses.'High-sensitivity' cardiac troponin assays are now the standard in human cardiology. OBJECTIVE: Appropriately validate the'high-sensitivity' cardiac Troponin-T (hscTnT) assay for clinical use in horses, establish reference intervals, determine the biological variation, and demonstrate assay utility in selected clinical cases. METHODS: Analytical validation of the Roche hscTnT assay included within- and between-run precision, linear dose response, limit of quantitation (LoQ), stability, and comparison with cTn-I (iSTAT). Reference intervals and biological variation were determined using adult, healthy, Non-Competition Horses (N = 125) and Racing-Thoroughbreds (N = 178). HscTnT levels were measured in two horses with cardiac pathology. RESULTS: The hscTnT demonstrates acceptable within-run (L1 = 6.5 ng/L, CV 14.9 %, L2 = 10.1 ng/L, CV 8.7 %, L3 = 15.3 ng/L, CV 5.4 %) and between-run precision (L1 = 12.2 ng/L, CV 8.4 %, L2 = 57.0 ng/L, CV 8.4 %, L3 = 256.0 ng/L, CV 9.0 %). The assay was linear from 3 to 391 ng/L. The LoQ was validated at 3 ng/L. Samples demonstrated insignificant decay over freeze-thaw cycle. Comparison with cTnI assay showed excellent correlation (range: 8.0-3535.0 ng/L, R(2) = 0.9996). Reference intervals: The upper 95(th) and 99(th) percentile of the hscTnT population distribution were 6.8 and 16.2 ng/L in Non-Competition Horses, and 14.0 and 23.2 ng/L in Racing-Thoroughbreds. Between-breed, diurnal effect, and between-day variation was below LoQ. Two clinical cases with presumed cardiac pathology had hscTnT levels of 220.9 ng/L and 5723.0 ng/L. CONCLUSIONS: This benchmark study is the first to comply with CLSI guidelines, thus further establishing the performance characteristics of the hscTnT assay, and reference intervals in healthy horses. Two clinical cases demonstrated further the clinical utility of the assay.
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Shields et al. (2016) conducted an observational in Healthy horses (n=303). High-sensitivity cardiac Troponin-T (hscTnT) assay was evaluated on 99th percentile upper reference limit of hscTnT. The upper 99th percentile reference limits for the high-sensitivity cardiac troponin-T assay were established at 16.2 ng/L in healthy non-competition horses and 23.2 ng/L in racing Thoroughbreds.
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