title: European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay.
abstract: BACKGROUND
  International recommendations highlight the superior value of cardiac troponins (cTns) for early diagnosis of myocardial infarction along with analytical requirements of improved precision and detectability. In this multicenter study, we investigated the analytical performance of a new high sensitive cardiac troponin I (hs-cTnI) assay and its 99th percentile upper reference limit (URL).
  
  
  METHODS
  Laboratories from nine European countries evaluated the ARCHITECT STAT high sensitive troponin I (hs-TnI) immunoassay on the ARCHITECT i2000SR/i1000SR immunoanalyzers. Imprecision, limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ) linearity of dilution, interferences, sample type, method comparisons, and 99th percentile URLs were evaluated in this study.
  
  
  RESULTS
  Total imprecision of 3.3%-8.9%, 2.0%-3.5% and 1.5%-5.2% was determined for the low, medium and high controls, respectively. The lowest cTnI concentration corresponding to a total CV of 10% was 5.6 ng/L. Common interferences, sample dilution and carryover did not affect the hs-cTnI results. Slight, but statistically significant, differences with sample type were found. Concordance between the investigated hs-cTnI assay and contemporary cTnI assay at 99th percentile cut-off was found to be 95%. TnI was detectable in 75% and 57% of the apparently healthy population using the lower (1.1 ng/L) and upper (1.9 ng/L) limit of the LoD range provided by the ARCHITECT STAT hs-TnI package insert, respectively. The 99th percentile values were gender dependent.
  
  
  CONCLUSIONS
  The new ARCHITECT STAT hs-TnI assay with improved analytical features meets the criteria of high sensitive Tn test and will be a valuable diagnostic tool.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Krintus
authors.forename: Marek
authors.initials: M
authors.lastname: Kozinski
authors.forename: Pascal
authors.initials: P
authors.lastname: Boudry
authors.forename: Nuria Estañ
authors.initials: NE
authors.lastname: Capell
authors.forename: Ursula
authors.initials: U
authors.lastname: Köller
authors.forename: Karl
authors.initials: K
authors.lastname: Lackner
authors.forename: Guillaume
authors.initials: G
authors.lastname: Lefèvre
authors.forename: Lieselotte
authors.initials: L
authors.lastname: Lennartz
authors.forename: Johannes
authors.initials: J
authors.lastname: Lotz
authors.forename: Antonio Mora
authors.initials: AM
authors.lastname: Herranz
authors.forename: Mads
authors.initials: M
authors.lastname: Nybo
authors.forename: Mario
authors.initials: M
authors.lastname: Plebani
authors.forename: Maria B
authors.initials: MB
authors.lastname: Sandberg
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schratzberger
authors.forename: Jessie
authors.initials: J
authors.lastname: Shih
authors.forename: Øyvind
authors.initials: Ø
authors.lastname: Skadberg
authors.forename: Ahmed Taoufik
authors.initials: AT
authors.lastname: Chargui
authors.forename: Martina
authors.initials: M
authors.lastname: Zaninotto
authors.forename: Grazyna
authors.initials: G
authors.lastname: Sypniewska
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001780:Blood Coagulation Tests / Q000295:instrumentation; D005060:Europe; D005260:Female; D006801:Humans; D007118:Immunoassay; D007753:Laboratories; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000097:blood*; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic; D019210:Troponin I