title: Long-time quality assessment of the Elecsys Troponin T hs assay.
abstract: Recently, Roche announced a problem with the calibrators for their high sensitive cardiac troponin T (hscTnT) assay. We have monitored the performance of the assay since its introduction into clinical use in December 2009 and we're in a unique position to provide quantitative information concerning the effects of this problem. Our data document that the measured cTnT concentration in the hscTnT assay dropped by 5.8 ng/L around the 99th percentile before its recalibration in May 2012. Thus, the hscTnT levels in our hospital have been underestimated around this cut-off value since its introduction. The approach we used may be one that other laboratories should consider.
authors.affiliation: Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska University Hospital at Sahlgrenska Academy, University of Gothenburg, S-413 45 Gothenburg, Sweden. Electronic address: ola.hammarsten@clinchem.gu.se.
authors.forename: Ola
authors.initials: O
authors.lastname: Hammarsten
authors.affiliation: Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska University Hospital at Sahlgrenska Academy, University of Gothenburg, S-413 45 Gothenburg, Sweden.
authors.forename: Carl-Eric
authors.initials: CE
authors.lastname: Jacobsson
authors.affiliation: Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska University Hospital at Sahlgrenska Academy, University of Gothenburg, S-413 45 Gothenburg, Sweden.
authors.forename: Monica
authors.initials: M
authors.lastname: Widegren
authors.affiliation: Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska University Hospital at Sahlgrenska Academy, University of Gothenburg, S-413 45 Gothenburg, Sweden.
authors.forename: Tatyana
authors.initials: T
authors.lastname: Danylchenko
authors.affiliation: Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN, USA; Division of Cardiovascular Diseases, Department of Laboratory, Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Allan S
authors.initials: AS
authors.lastname: Jaffe
mesh_terms: D002138:Calibration; D002624:Chemistry, Clinical / Q000379:methods*; D006801:Humans; D011785:Quality Assurance, Health Care; D012680:Sensitivity and Specificity; D013997:Time Factors; D020107:Troponin T / Q000097:blood*
chemical_list: D020107:Troponin T
keywords: Calibration; High sensitive troponin assays