title: Analytical evaluation of point of care cTnT and clinical performances in an unselected population as compared with central laboratory highly sensitive cTnT.
abstract: OBJECTIVE
  To report the analytical performances of the Radiometer AQT90 FLEX® cTnT assay (Neuilly-Plaisance, France) and to evaluate the concordance with hs-cTnT results from central laboratory for the diagnosis of acute myocardial infarction (AMI) at baseline and during a short follow-up among unselected patients admitted in emergency room or cardiology department.
  
  
  METHODS
  Analytical performances of AQT90 FLEX® cTnT immunoassay included imprecision study with determination of a coefficient of variation at 10% and 20%, linearity, and limit of detection. The concordance study was based on samples obtained from 170 consecutive patients with chest pain suggestive of acute coronary syndrome (ACS) admitted in the emergency room or cardiology department. The kinetic study (within 62 additional samples 3h later) was based on absolute delta criterion and the combination of relative change of 30% with absolute change of 7ng/L.
  
  
  RESULTS
  The cTnT assay from Radiometer was evaluated as clinically usable, although less sensitive than the Roche hs-cTnT assay as demonstrated by the concordance and the kinetic studies.
  
  
  CONCLUSIONS
  In non-selected population, the cTnT AQT Flex© assay on AQT90© with kinetic change at 3h, provides similar clinical classification of patients, particularly for AMI group as compared to central laboratory hs-cTnT assay and could be suitable for clinical use.
authors.affiliation: Biochemistry Laboratory, Lapeyronie Hospital, Montpellier, France.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Dupuy
authors.affiliation: Emergency Department, Lapeyronie Hospital, Montpellier, France.
authors.forename: Mustapha
authors.initials: M
authors.lastname: Sebbane
authors.affiliation: Cardiology Department, Arnaud de Villeneuve Hospital, Montpellier, France.
authors.forename: François
authors.initials: F
authors.lastname: Roubille
authors.affiliation: Biochemistry Laboratory, Lapeyronie Hospital, Montpellier, France.
authors.forename: Thibault
authors.initials: T
authors.lastname: Coste
authors.affiliation: Biochemistry Laboratory, Lapeyronie Hospital, Montpellier, France.
authors.forename: Anne Sophie
authors.initials: AS
authors.lastname: Bargnoux
authors.affiliation: Biochemistry Laboratory, Lapeyronie Hospital, Montpellier, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Badiou
authors.affiliation: Biochemistry Laboratory, Lapeyronie Hospital, Montpellier, France.
authors.forename: Nils
authors.initials: N
authors.lastname: Kuster
authors.affiliation: Biochemistry Laboratory, Lapeyronie Hospital, Montpellier, France. Electronic address: jp-cristol@chu-montpellier.fr.
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Cristol
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood* / Q000175:diagnosis; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D002637:Chest Pain / Q000097:blood* / Q000175:diagnosis; D004636:Emergency Service, Hospital / Q000592:standards*; D005260:Female; D006801:Humans; D007755:Laboratories, Hospital / Q000592:standards*; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems / Q000592:standards*; D011874:Radiometry / Q000379:methods / Q000592:standards; D020107:Troponin T / Q000097:blood*; D055815:Young Adult
chemical_list: D015415:Biomarkers; D020107:Troponin T
keywords: Diagnostic performance; Highly sensitive cardiac troponin; Kinetic change; Point of care