Analytical evaluation of Lumipulse® BRAHMS PCT CLEIA assay and clinical performances in an unselected population as compared with central lab PCT assay

Abstract

ObjectivesWe 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. Design and methodsLumipulse®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©. ResultsThe 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. ConclusionThe new adaptation developed from Fujirebio on quantification of PCT with CLEIA technology from monoclonal antibodies from ThermoFisher appears to be acceptable for clinical use.