title: Analytical evaluation of Lumipulse® BRAHMS PCT CLEIA assay and clinical performances in an unselected population as compared with central lab PCT assay.
abstract: OBJECTIVE
  We report the analytical performances of the Lumipulse®G BRAHMS PCT assay (Fujirebio, Courteboeuf, France) and the concordance with BRAHMS PCT Kryptor CompactPlus© results from central laboratory.
  
  
  METHODS
  Lumipulse®G BRAHMS PCT immunoassay on Lumipulse®G600II instrument is a chemiluminescence enzyme immunoassay (CLEIA). Analytical performances included imprecision study, linearity, limit of detection and comparison study on 138 plasma specimen on Lumipulse®G600II vs plasma on Kryptor CompactPlus©.
  
  
  RESULTS
  The intra and inter assay imprecision of Lumipulse®G BRAHMS PCT was between 2 and 5%. The LoD in our condition was 0.0029ng/mL in accordance with the LoD provided by the manufacturer (0.0048ng/mL). The linear equation of linearity was y=1,001×-0,052 with r2=0.99, with a mean recovery (SD) percentage of 1.8% (8%). Correlation studies showed a good correlation (r=0.99) between plasma on Kryptor and Lumipulse, with a bias of 0.02 in the range from 0.12 to 1ng/mL.
  
  
  CONCLUSIONS
  The new adaptation developed from Fujirebio on quantification of PCT with CLEIA technology from monoclonal antibodies from ThermoFisher appears to be acceptable for clinical use.
authors.affiliation: Department of Biochemistry, Centre Ressources Biologiques de Montpellier, University Hospital of Montpellier, Montpellier, France.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Dupuy
authors.affiliation: Department of Biochemistry, Centre Ressources Biologiques de Montpellier, University Hospital of Montpellier, Montpellier, France.
authors.forename: Maxence
authors.initials: M
authors.lastname: Né
authors.affiliation: Department of Biochemistry, Centre Ressources Biologiques de Montpellier, University Hospital of Montpellier, Montpellier, France; PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, 34295 Montpellier cédex 5, France.
authors.forename: Anne Sophie
authors.initials: AS
authors.lastname: Bargnoux
authors.affiliation: Department of Biochemistry, Centre Ressources Biologiques de Montpellier, University Hospital of Montpellier, Montpellier, France; PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, 34295 Montpellier cédex 5, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Badiou
authors.affiliation: Department of Biochemistry, Centre Ressources Biologiques de Montpellier, University Hospital of Montpellier, Montpellier, France; PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, 34295 Montpellier cédex 5, France. Electronic address: jp-cristol@chu-montpellier.fr.
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Cristol
mesh_terms: D015415:Biomarkers / Q000097:blood; D002116:Calcitonin / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D057230:Limit of Detection
chemical_list: D015415:Biomarkers; D002116:Calcitonin
keywords: Clinical concordance; PCT; Sensitivity; Specificity