Analytical performances of a novel point-of-care procalcitonin assay.

Autor:	Dupuy AM; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, F-34295, cédex 5, France., Bargnoux AS; Laboratoire de Biochimie et Hormonologie, PhyMedExp, Université de Montpellier, INSERM, CNRS, CHU de Montpellier, France., Andreeva A; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, F-34295, cédex 5, France., Zins C; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, F-34295, cédex 5, France., Kuster N; Laboratoire de Biochimie et Hormonologie, PhyMedExp, Université de Montpellier, INSERM, CNRS, CHU de Montpellier, France., Badiou S; Laboratoire de Biochimie et Hormonologie, PhyMedExp, Université de Montpellier, INSERM, CNRS, CHU de Montpellier, France., Cristol JP; Laboratoire de Biochimie et Hormonologie, PhyMedExp, Université de Montpellier, INSERM, CNRS, CHU de Montpellier, France.
Jazyk:	angličtina
Zdroj:	Practical laboratory medicine [Pract Lab Med] 2019 Oct 26; Vol. 18, pp. e00145. Date of Electronic Publication: 2019 Oct 26 (Print Publication: 2020).
DOI:	10.1016/j.plabm.2019.e00145
Abstrakt:	Objectives: We report the analytical performances of a new point-of-care (POC) procalcitonin (PCT) fluorescence immunoassay that uses the AFIAS-6© system from Boditech and its concordance with results of the standard method Kryptor Compact plus from the central laboratory. Design: and methods: Analytical performances including imprecision studies, limit of blank (LoB), limit of detection (LoD) and limit of quantification (LOQ) were determined. The method comparison was performed using plasma vs. whole blood for Kryptor CompactPlus© vs. AFIAS-6©, respectively. Results: The total imprecision was far from the CV of 4.5% claimed by the manufacturer and close to 10%, for levels of PCT at 0.4 and 8.3 μg/L. The LoD of this novel PCT assay was found to close to the LoD provided by the manufacturer at 0.04 μg/L. The LOQ was higher than that claimed by the manufacturer (0.1 vs 0.002, respectively). The equation of linearity in the lower range was found to be y = 1.056x - 0.039 with r 2  = 0.993 with a mean recovery percentage of 86 ± 15%. Correlation studies showed a good correlation between PCT measurements using plasma on Kryptor system and on corresponding whole blood with POC reaching a bias of -0.04 in the range from 0.02 to 2 μg/L. Conclusion: The novel PCT assay on AFIAS-6© is an acceptable POC alternative for the diagnosis and management of sepsis at EDs to improve the flow of patients, as results are consistent with those of the standard PCT Kryptor Compact Plus© assay, despite its higher imprecision. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (© 2019 The Authors.)
Databáze:	MEDLINE
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