Evaluation of the ARCHITECT STAT troponin-I assay.
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 microg/l (mean of low control), 0.49 microg/l (medium control) and 11.2 microg/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 microg/l, while the 99th percentile of the reference range derived from 130 apparently healthy subjects was determined as 0.02 microg/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.
Hubl
Walter
W
Institut für Klinische Chemie und Laboratoriumsmedizin, Krankenhaus Dresden-Friedrichstadt, Dresden, Germany.
Demant
Thomas
T
Gladrow
Eberhard
E
D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000379:methods; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000032:analysis*
D019210:Troponin I