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

Author:

Müller-Bardorff Margit1,Hallermayer Klaus2,Schröder Angelika3,Ebert Christoph3,Borgya Anneliese3,Gerhardt Willie4,Remppis Andrew1,Zehelein Jörg2,Katus Hugo A1

Affiliation:

1. Medizinische Klinik II, University of Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany

2. Abteilung Innere Medizin III, University of Heidelberg, Heidelberg, Germany

3. Boehringer Research Center, Tutzing, Germany

4. Department of Clinical Chemistry, Lasarettet, Helsingborg, Sweden

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second-generation troponin T ELISA (TnT 2) was developed, in which the cross-reactive antibody 1B10 has been replaced by a high-affinity cardiac-specific antibody M11.7.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.

Publisher

Oxford University Press (OUP)

Subject

Biochemistry, medical,Clinical Biochemistry

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