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Abstract |
Evaluation of the ARCHITECT STAT Troponin-I Assay |
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We evaluated the immunoassay for troponin I (TnI) which is now available on the integrated ARCHITECT analyzer ci8200 from Abbott. Coefficients of variation (CV) for between-day imprecision were 5.6%, 4.7% and 5.1% at TnI levels of 0.13 μg/l (mean of low control), 0.49 μg/l (medium control) and 11.2 μg/l (high control), respectively. All measurements of controls lay within pre-specified concentration ranges. The functional sensitivity at an imprecision level of 10% was found to be 0.04 μg/l, while the 99th percentile of the reference range derived from 130 apparently healthy subjects was determined as 0.02 μg/l with a corresponding CV of 15%. Thus, as none of the currently reported TnI tests the ARCHITECT STAT assay does not meet exactly the ESC/ACC consensus criteria for troponin testing but seems to perform better than many of the tests currently used in practice. |
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