Innotrac Aio! Second-Generation Cardiac Troponin I Assay: Imprecision Profile and Other Key Characteristics for Clinical Use

[摘要] Cardiac troponin has been designated as the preferred biomarker for diagnosis of myocardial infarction (MI) (1). Previously published data, however, confirm the large diversity among cardiac troponin assays with respect to important analytical characteristics, including assay standardization, antibody specificity, interferences, and assay imprecision, and underscore the need for improved cardiac troponin assays (2)(3). Results obtained with more recently released next-generation assays show that the newer assays indeed have substantially improved analytical performance (4)(5). The aim of this study was to evaluate one of these next-generation cardiac troponin I (cTnI) assays, performed on the Aio!™ immunoanalyzer (Innotrac Diagnostics Oy), by defining key performance characteristics, including detection limit, linearity on dilution, imprecision, reference interval, and cutoff for MI diagnosis.The assay is based on “all-in-one” dry chemistry technology, in which all of the reagents are precoated in assay cups, and time-resolved fluorometric detection, with a total analysis time of <20 min (6). An eight-point factory-constructed calibration curve is provided on a bar code with each reagent lot, and the instrument-specific calibration adjustment is performed by running the cups of the appropriate calibration …

[学科分类] 过敏症与临床免疫学