Improved troponin T ELISA specific for cardiac troponin T isoform: assay development and analytical and clinical validation

Abstract

AbstractThe first generation of troponin T ELISA (TnT 1) can yield false-positive results in patients with severe skeletal muscle injury. Therefore, a cardiac-specific second-generation troponin T ELISA (TnT 2) was developed, in which the cross-reactive antibody 1B10 has been replaced by a high-affinity cardiac-specific antibody M11.7. No cross-reactivity of TnT 2 was observed with purified skeletal muscle troponin T (1000 μg/L) or in test samples from 43 marathon runners and 24 patients with rhabdomyolysis and highly increased creatine kinase. TnT 2 was increased >0.2 μg/L in 5 of 40 patients with renal failure and in 4 of 20 muscular dystrophy patients. The detection limit is 0.012 μg/L. Day-to-day imprecision (CV) within the range 0.19–14.89 μg/L was <5.8%. In 4955 patients without myocardial damage, 99.6% had TnT <0.10 μg/L. Assay comparison (TnT 1 vs TnT 2) over the whole concentration range (i.e., in 323 samples from AMI-suspected patients) showed a slope, intercept, and standard error of estimate (Sey) of 1.18, 0.01 μg/L, and 0.81 μg/L, respectively.