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

被引：0
作者：
Gallian, Pierre [1 ,2 ,7 ]
Dupont, Isabelle [3 ]
Lacoste, Marjorie [4 ]
Brisbarre, Nadege [2 ,5 ]
Isnard, Christine [2 ,5 ]
Delouane, Idriss [6 ]
Richard, Pascale [1 ]
Morel, Pascal [1 ]
Laperche, Syria [1 ]
de Lamballerie, Xavier [2 ]
机构：
[1] Etab Francais Sang, La Plaine St Denis, France
[2] Aix Marseille Univ, Unite Virus Emergents UVE, IRD 190, Inserm 1207, Marseille, France
[3] Etab Francais Sang Bretagne, Brest, France
[4] Etab Francais Sang Occitanie, Toulouse, France
[5] Etab Francais Sang Provence Alpes Cote Azur Corse, Marseille, France
[6] Etab francais sang, St Denis, Reunion, France
[7] Etab Francais Sang PACA Corse, 149 Blvd Baille, F-13005 Marseille, France
来源：
TRANSFUSION | 2024年 / 64卷 / 08期
关键词：
blood safety; chikungunya; dengue; level of detection; NAT; REUNION ISLAND; OUTBREAK; DONORS;
D O I：
10.1111/trf.17921
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
BackgroundThe 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 MethodsUsing 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.ResultsFor 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.DiscussionThe 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.
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页码：1503 / 1508
页数：6
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