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

OBJECTIVES: We report the analytical performances of the Lumipulse(R)G BRAHMS PCT assay (Fujirebio, Courteboeuf, France) and the concordance with BRAHMS PCT Kryptor CompactPlus(c) results from central laboratory. DESIGN AND METHODS: Lumipulse(R)G BRAHMS PCT immunoassay on Lumipulse(R)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(R)G600II vs plasma on Kryptor CompactPlus(c). RESULTS: The intra and inter assay imprecision of Lumipulse(R)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=1,001x-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. CONCLUSION: 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.

2017
  • Dupuy A M
  • Ne M
  • Bargnoux A S
  • Badiou S
  • Cristol J P

CallNum: 

2.38
|
  • Clin Biochem
Nov 09;50(4-5):248-50