title: Multicenter evaluation of a second-generation assay for cardiac troponin T.
abstract: We report on the evaluation of the second-generation assay for cardiac troponin T (cTnT) on the Enzymun system. This new assay is completely specific for the cardiac isoform of TnT, utilizing two cardiospecific monoclonal antibodies. The assay time is reduced to 45 min. The interassay precision shows a median CV of 5.5%; 20% interassay CV was found between 0.05 and 0.1 microg/L. The cardiosensitivity of the second-generation cTnT assay in patients with ischemic myocardial injury appears equivalent when compared with the first-generation assay. We found no falsely positive results in patients with skeletal muscle damage including multitraumas, surgery patients, and marathon runners who showed highly increased values with the unspecific first-generation assay. In Duchenne disease cTnT was still increased, but to a much lower extent. cTnT remains increased in renal failure, but to a lesser degree than with the first-generation assay. The cause of this increase remains unclear. Although a cross-reactivity of skeletal muscle TnT in the second-generation assay could be excluded by our findings, minor myocardial damage or expression of the cardiac isoform of TnT in regenerating muscles cannot be ruled out in those cases with apparently falsely increased cTnT values. The second-generation cTnT assay is a step forward in the combination of cardiosensitivity and cardiospecificity in biochemical markers for diagnosis of heart disease.
authors.affiliation: Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der TU München, Germany. baum@mail.klinchem.med.tu-muenchen.de
authors.forename: H
authors.initials: H
authors.lastname: Baum
authors.forename: S
authors.initials: S
authors.lastname: Braun
authors.forename: W
authors.initials: W
authors.lastname: Gerhardt
authors.forename: G
authors.initials: G
authors.lastname: Gilson
authors.forename: G
authors.initials: G
authors.lastname: Hafner
authors.forename: M
authors.initials: M
authors.lastname: Müller-Bardorff
authors.forename: W
authors.initials: W
authors.lastname: Stein
authors.forename: G
authors.initials: G
authors.lastname: Klein
authors.forename: C
authors.initials: C
authors.lastname: Ebert
authors.forename: K
authors.initials: K
authors.lastname: Hallermayer
authors.forename: H A
authors.initials: HA
authors.lastname: Katus
mesh_terms: D016477:Artifacts; D015415:Biomarkers / Q000032:analysis; D006801:Humans; D018482:Muscle, Skeletal / Q000737:chemistry; D017202:Myocardial Ischemia / Q000175:diagnosis*; D009206:Myocardium / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014336:Troponin / Q000032:analysis*; D019209:Troponin C / Q000032:analysis*; D020107:Troponin T
chemical_list: D015415:Biomarkers; D014336:Troponin; D019209:Troponin C; D020107:Troponin T