title: Performance evaluation and subsequent clinical experience with the Abbott Automated Architect STAT Troponin-I assay.
abstract: BACKGROUND
  Cardiac troponins are specific biochemical markers of myocardial injury used in the diagnosis of acute myocardial disease and cardiac risk stratification. To avoid misclassification of patients, troponin assays must demonstrate precision at the low end of the measuring range. We report our evaluation of the Architect STAT Troponin-I assay (Abbott Diagnostics), comparison of low-positive results with 2 other assays, and occurrence of heterophile antibody interference in the assay.
  
  
  METHODS
  We assessed analytical performance on the ci8200 according to CLSI protocols, using quality-control and patient samples. Our healthy reference population included 480 blood donors. For correlation studies against the AxSYM first-generation cTnI (Abbott Diagnostics) and Access second-generation AccuTnI (Beckman Coulter) assays, we used 339 samples from hospital patients.
  
  
  RESULTS
  The CV of the Architect STAT Troponin-I assay was 10% near the 99th percentile for the reference population (0.03 microg/L). Comparison with the AxSYM first-generation cTnI assay showed good correlation at higher concentrations, but better sensitivity of the Architect cTnI assay at low concentrations, which were clinically relevant as shown by review of patient histories. Correlation was good at the low end of the measuring range with the Access second-generation AccuTnI. Over the last 12 months we have identified 6 patients with heterophile antibodies causing positive interference.
  
  
  CONCLUSIONS
  The Architect STAT Troponin-I assay provides highly sensitive measurement of cTnI with a CV of 10% near the upper limit of a reference population; however, heterophile antibodies can interfere with this assay.
authors.affiliation: Clinical Biochemistry Unit, Alfred Pathology Service, The Alfred Hospital, Department of Medicine, Monash University, Melbourne, Australia.
authors.forename: Que
authors.initials: Q
authors.lastname: Lam
authors.forename: Marion
authors.initials: M
authors.lastname: Black
authors.forename: Odette
authors.initials: O
authors.lastname: Youdell
authors.forename: Heather
authors.initials: H
authors.lastname: Spilsbury
authors.forename: Hans-Gerhard
authors.initials: HG
authors.lastname: Schneider
mesh_terms: D002624:Chemistry, Clinical / Q000295:instrumentation / Q000379:methods; D006801:Humans; D012016:Reference Values; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000032:analysis* / Q000097:blood
chemical_list: D019210:Troponin I