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

Abstract : OBJECTIVES: 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. DESIGN AND 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. 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.
Type de document :
Article dans une revue
Liste complète des métadonnées

https://hal.umontpellier.fr/hal-01801582
Contributeur : Anne-Cécile Saye <>
Soumis le : lundi 27 janvier 2020 - 11:01:29
Dernière modification le : mercredi 29 janvier 2020 - 10:48:30

Fichier

2017 Dupuy et al., Analytical ...
Fichiers produits par l'(les) auteur(s)

Identifiants

Collections

Citation

Anne Marie Dupuy, Maxence Né, Anne Sophie Bargnoux, Stéphanie Badiou, Jean Paul Cristol. Analytical evaluation of Lumipulse® BRAHMS PCT CLEIA assay and clinical performances in an unselected population as compared with central lab PCT assay. Clinical Biochemistry, Elsevier, 2017, 50 (4-5), pp.248 - 250. ⟨10.1016/j.clinbiochem.2016.11.006⟩. ⟨hal-01801582⟩

Partager

Métriques

Consultations de la notice

74

Téléchargements de fichiers

13