Evaluation of assays for nucleic acid testing for the prevention of chikungunya and dengue virus transmission by blood transfusion.

Autor: Gallian P; Etablissement Français du Sang, La Plaine Saint Denis, France.; Unité des Virus Emergents (UVE: Aix-Marseille Univ-IRD 190-Inserm 1207), Marseille, France., Dupont I; Etablissement Français du Sang Bretagne, Brest, France., Lacoste M; Etablissement Français du Sang Occitanie, Toulouse, France., Brisbarre N; Unité des Virus Emergents (UVE: Aix-Marseille Univ-IRD 190-Inserm 1207), Marseille, France.; Etablissement Français du Sang Provence Alpes Côte d'Azur et Corse, Marseille, France., Isnard C; Unité des Virus Emergents (UVE: Aix-Marseille Univ-IRD 190-Inserm 1207), Marseille, France.; Etablissement Français du Sang Provence Alpes Côte d'Azur et Corse, Marseille, France., Delouane I; Établissement français du sang, La Réunion-Océan Indien. St-Denis, Réunion, France., Richard P; Etablissement Français du Sang, La Plaine Saint Denis, France., Morel P; Etablissement Français du Sang, La Plaine Saint Denis, France., Laperche S; Etablissement Français du Sang, La Plaine Saint Denis, France., de Lamballerie X; Unité des Virus Emergents (UVE: Aix-Marseille Univ-IRD 190-Inserm 1207), Marseille, France.
Jazyk: angličtina
Zdroj: Transfusion [Transfusion] 2024 Aug; Vol. 64 (8), pp. 1503-1508. Date of Electronic Publication: 2024 Jun 15.
DOI: 10.1111/trf.17921
Abstrakt: Background: The large dengue (DENV) and chikungunya (CHIKV) outbreaks observed during the last decade across the world, as well as local transmissions in non-endemic areas are a growing concern for blood safety. The aim of this study was to evaluate and compare the sensitivity of nucleic acid tests (NAT) detecting DENV and CHIKV RNA.
Materials and Methods: Using DENV 1 to 4 International Standards, the limits of detection (LODs) calculated by probit analysis of two NAT assays; the cobas CHIKV/DENV assay (Roche Diagnostics) and the Procleix Dengue Virus Assay (Grifols) were compared. In addition, CHIKV-RNA LOD of the cobas CHIKV/DENV assay was evaluated.
Results: For dengue, the 95% LOD of the cobas assay ranged between 4.10 [CI95%: 2.70-8.19] IU/mL (DENV-2) and 7.07 [CI95%: 4.34-14.89] IU/mL (DENV-4), and between 2.19 [CI95%: 1.53-3.83] IU/mL (DENV-3) and 5.84 [CI95%: 3.84-10.77] IU/mL (DENV-1) for Procleix assay. The Procleix assay had a significant lower LOD for DENV-3 (2.19 vs. 5.89 IU/mL) when compared to the cobas assay (p = 0.005). The 95% LOD for CHIKV-RNA detection of the cobas assay was 4.76 [CI95%: 3.08-8.94] IU/mL.
Discussion: The two NAT assays developed for blood donor screening evaluated in this study demonstrated high and similar analytical performance. Subject to an appropriate risk-benefit assessment, they can be used to support blood safety during outbreaks in endemic areas or in non-endemic areas as an alternative to deferring blood donors during local transmission likely to affect the blood supply. The development of multiplex assays is expected to optimize laboratory organization.
(© 2024 The Author(s). Transfusion published by Wiley Periodicals LLC on behalf of AABB.)
Databáze: MEDLINE
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