title: A new immunochemistry platform for a guideline-compliant cardiac troponin T assay at the point of care: proof of principle.
abstract: BACKGROUND
  A multitude of troponin assays for the point-of-care (POC) have been developed showing a lack of analytical sensitivity and precision. We present a new platform solution for the high-sensitivity detection of cardiac troponin T (cTnT) in a 30 μL whole blood sample with a turnaround time of 11 min.
  
  
  METHODS
  The immunoassay was completely run in a ready-to-use plastic disposable, a centrifugal microfluidic disc with fully integrated reagents. After the sample application, the assay was automatically processed by separating the cellular blood components via centrifugation, followed by incubation of a defined volume from the generated plasma with the immunoreagents. The fluorescence in the signal zone of a membrane was measured after its washing for the cTnT quantitation.
  
  
  RESULTS
  A calibration curve, measured in whole blood samples spiked with native human cTnT, was generated covering a range up to a concentration of approximately 8300 ng/L. The lower detection limit was determined to be 3.0 ng/L. At a concentration of 14 ng/L, the 99th percentile value from the high-sensitivity cardiac troponin T (hs-cTnT) assay in the Elecsys® system, the imprecision (CV) was 3.8%. A CV profile indicated that the functional sensitivity for a CV <10% was 6.8 ng/L. The assay did not show any significant cross-reaction with human skeletal troponin T. We observed an excellent correlation with the hs-TnT Elecsys® assay for 49 clinical plasma samples (r=0.9744).
  
  
  CONCLUSIONS
  The described technology shows that an analytical performance for a highly sensitive determination of cTnT can be achieved in a POC setting.
authors.affiliation: .
authors.forename: Eloisa
authors.initials: E
authors.lastname: Lopez-Calle
authors.affiliation: .
authors.forename: Pamela
authors.initials: P
authors.lastname: Espindola
authors.affiliation: .
authors.forename: Juergen
authors.initials: J
authors.lastname: Spinke
authors.affiliation: .
authors.forename: Sascha
authors.initials: S
authors.lastname: Lutz
authors.affiliation: .
authors.forename: Alfons
authors.initials: A
authors.lastname: Nichtl
authors.affiliation: .
authors.forename: Armin
authors.initials: A
authors.lastname: Tgetgel
authors.affiliation: .
authors.forename: Nicolas
authors.initials: N
authors.lastname: Herbert
authors.affiliation: .
authors.forename: Moritz
authors.initials: M
authors.lastname: Marcinowski
authors.affiliation: .
authors.forename: Juergen
authors.initials: J
authors.lastname: Klepp
authors.affiliation: .
authors.forename: Thomas
authors.initials: T
authors.lastname: Fischer
authors.affiliation: .
authors.forename: Thorsten
authors.initials: T
authors.lastname: Brueckner
authors.affiliation: .
authors.forename: Christoph
authors.initials: C
authors.lastname: Boehm
authors.affiliation: .
authors.forename: Thomas
authors.initials: T
authors.lastname: Keller
mesh_terms: D002138:Calibration; D017408:Guidelines as Topic; D006801:Humans; D007118:Immunoassay / Q000592:standards; D057230:Limit of Detection; D009203:Myocardial Infarction / Q000175:diagnosis; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D020107:Troponin T / Q000097:blood* / Q000592:standards
chemical_list: D011933:Reagent Kits, Diagnostic; D020107:Troponin T
keywords: acute myocardial infarction; centrifugal microfluidic disc; guideline-compliant cardiac troponin T; high-Sensitivity cardiac troponin T; lateral-flow; point-of-care test