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Clinical Chemistry 43: 458-466, 1997;
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(Clinical Chemistry. 1997;43:458-466.)
© 1997 American Association for Clinical Chemistry, Inc.

Articles

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

Margit Müller-Bardorff1, Klaus Hallermayer2, Angelika Schröder3, Christoph Ebert3, Anneliese Borgya3, Willie Gerhardt4, Andrew Remppis1, Jörg Zehelein2 and Hugo A. Katus1,a

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.
a Author for correspondence. Fax 49/451/5006437; e-mail Medizinische Universit{at}t zu Lübeck.

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second-generation troponin T ELISA (TnT 2) was developed, in which the cross-reactive antibody 1B10 has been replaced by a high-affinity cardiac-specific antibody M11.7.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


Key Words: indexing terms: cardiac markers • monoclonal antibodies • biotin–streptavidin interaction • creatine kinase




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