Open AccessEvaluation of Analytical Performance of the Siemens ADVIA TnI Ultra Immunoassay
Author(s) -
Concetta Prontera,
Antonio Fortunato,
Simona Storti,
Antonella Mercuri,
G. Longombardo,
Gian Carlo Zucchelli,
Michele Emdin,
Aldo Clerico
Publication year - 2007
Publication title -
clinical chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.705
H-Index - 218
eISSN - 1530-8561
pISSN - 0009-9147
DOI - 10.1373/clinchem.2007.089995
Subject(s) - detection limit , troponin i , siemens , chromatography , immunoassay , chemiluminescence , chemistry , medicine , nuclear medicine , antibody , immunology , physics , quantum mechanics , myocardial infarction
In light of recommendations on the quality (1) and clinical use (2) of troponin assays, we evaluated the analytical performance of the ADVIA Centaur and ADVIA CP® platforms (TnI-Ultra, Siemens Medical Solutions Diagnostics SrL) for measurement of cardiac troponin I (cTnI). The chemiluminescent TnI-Ultra method uses 2 monoclonal capture antibodies directed to epitopes at amino acids 41–49 and 87–91 and a tracer polyclonal goat antibody labeled with acridinium ester, directed against amino acids 27–40 (1)(3)(4). Two clinical laboratories participated in the study: the CNR Institute of Physiology in Pisa and the San Bortolo Hospital in Vicenza.The limit of detection (limit of the blank) for the TnI-Ultra method was calculated as the concentration corresponding to a signal of 3 SD above the mean of 60 replicates (obtained in 4 different runs and pooled together) for the calibrator in which cTnI was absent; a mean cTnI concentration of 0.006 μg/L was found. The total imprecision …
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