title: [Field assessment of the new rapid diagnostic test Ebola eZYSCREEN®].
abstract: During the Ebola virus disease outbreak in West Africa in 2014, the World Health Organization has pointed out the need for rapid diagnostic tests (RDT) affordable, sensitive, specific, user-friendly, rapid, equipment-free, and deliverable. The rapid diagnostic test (Lateral Flow Assay) Ebola eZYSCREEN® was developed in this emergency frame using monoclonal antibodies against the envelope glycoprotein of the virus. Two distinct versions have been industrialized, one for whole-blood samples and the other for serum/plasma samples. Both versions have an analytical detection limit of 105pfu/ml, the stability is at least 393 days at 30°C and 120 days at 45°C. The nonretrospective and independent validation study was carried out in the course of the outbreak in Conakry and at the Ebola Treatment Center of Coyah (Guinea) on 144 patients. In this study, the RDT showed a sensitivity of 65.3% and a specificity of 98.9% on whole blood, a sensitivity of 74.5% and a specificity of 100% on serum. Results from the whole-blood version must be analyzed with caution because of the delay between the blood collection and the completion of the tests, which was out of specification (3 days on average instead of 2 h). In contrast to laboratory tests, this easy to use field test does not require sophisticated instrumentation or even electricity and can contribute to the diagnostic chain of Ebola virus disease taking into account its benefits, high stability, and specificity but also its limit of sensitivity compared to laboratory techniques RT-qPCR (Real-Time reverse transcription Polymerase Chain Reaction), which remain the reference for the diagnosis of Ebola. The RDT Ebola eZYSCREEN® was granted EC IVD (IVD = In Vitro Diagnostic) marking.
authors.affiliation: CEA, DRF/IBITECS/SPI/Li2D, laboratoire innovations technologiques pour la détection et le diagnostic, BP 17171, 30207, Bagnols-sur-Cèze, France.
authors.forename: F
authors.initials: F
authors.lastname: Gallais
authors.affiliation: BioMérieux, 376, chemin de l'Orme, 69280, Marcy-l'Étoile, France.
authors.forename: F
authors.initials: F
authors.lastname: Gay-Andrieu
authors.affiliation: Fondation Mérieux, 17, rue Bourgelat, 69002, Lyon, France.
authors.forename: V
authors.initials: V
authors.lastname: Picot
authors.affiliation: Hôpital national de Donka, Conakry, Guinea.
authors.forename: N
authors.initials: N
authors.lastname: Magassouba
authors.affiliation: Laboratoire P4 Jean-Mérieux, Inserm, 69365, Lyon, France.
authors.forename: S
authors.initials: S
authors.lastname: Mély
authors.affiliation: Institut de recherche biomédicale des armées, D19, 91220, Brétigny-sur-Orge, France.
authors.forename: C N
authors.initials: CN
authors.lastname: Peyrefitte
authors.affiliation: CEA, DRF/IBITECS/SPI/Li2D, laboratoire innovations technologiques pour la détection et le diagnostic, BP 17171, 30207, Bagnols-sur-Cèze, France. laurent.bellanger@cea.fr.
authors.forename: L
authors.initials: L
authors.lastname: Bellanger
mesh_terms: D003955:Diagnostic Tests, Routine / Q000379:methods*; D029043:Ebolavirus / Q000276:immunology; D016701:Guinea; D019142:Hemorrhagic Fever, Ebola / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Conakry; Ebola; Ebola Treatment Center of Coyah; Ebola virus disease; Epidemic; Guinea; RDT; Rapid diagnostic test; Sub-Saharan Africa