1. Characterization and analytical validation of a new antigenic rapid diagnostic test for Ebola virus disease detection
- Author
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Julie Chaix, Stéphane Mély, Adrien Lugari, Atsuhiko Wada, Philippe Leissner, Karen Louis, Maxime Mistretta, Takeshi Yamamoto, Moriba Povogui, Céline Couturier, Maryline Ripaux, Sabine Godard, Jean Hébélamou, Delphine Pannetier, Charlotte Mignon, Anne Bocquin, Christophe Védrine, Patrick Lécine, Benoit Beitz, Bettina Werle, David Leuenberger, Ismaël Béavogui, Bodescot, Myriam, BIOASTER Microbiology Technology Institute [Lyon], FUJIFILM [Kaisei, Ashigarakami, Kanagawa, Japon], Centre de Recherche et de Formation en Infectiologie de Guinée [Conakry, Guinée] (CERFIG), Laboratoire P4 - Jean Mérieux, Centre Européen de Virologie/Immunologie-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Spécialisé de Macenta [Guinée] (CHRS Macenta), and The work performed by BIOASTER received funding from the French Government as part of the 'Programme des Investissements d’Avenir' (grant n˚ANR-10-AIRT-03) and from FUJIFILM.
- Subjects
0301 basic medicine ,RNA viruses ,Viral Diseases ,Physiology ,RC955-962 ,Molecular Diagnostic Method ,Monkeys ,medicine.disease_cause ,Pathology and Laboratory Medicine ,0302 clinical medicine ,Arctic medicine. Tropical medicine ,Medicine and Health Sciences ,Enzyme-Linked Immunoassays ,[SDV.BBM.BC] Life Sciences [q-bio]/Biochemistry, Molecular Biology/Biochemistry [q-bio.BM] ,Antigens, Viral ,[SDV.MP.VIR] Life Sciences [q-bio]/Microbiology and Parasitology/Virology ,Mammals ,Immunoassay ,Rapid diagnostic test ,Mammalian Genomics ,Eukaryota ,Genomics ,Ebolavirus ,3. Good health ,[SDV.BBM.BC]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Biomolecules [q-bio.BM] ,Body Fluids ,Blood ,Infectious Diseases ,Medical Microbiology ,Filoviruses ,Viral Pathogens ,[SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology ,Viruses ,Vertebrates ,Public aspects of medicine ,RA1-1270 ,Anatomy ,Pathogens ,Ebola Virus ,Research Article ,Neglected Tropical Diseases ,Primates ,Point-of-Care Systems ,030231 tropical medicine ,Research and Analysis Methods ,Microbiology ,Ebola Hemorrhagic Fever ,Typhoid fever ,Virus ,Blood Plasma ,03 medical and health sciences ,Diagnostic Medicine ,medicine ,Genetics ,Animals ,Humans ,[SDV.BBM.BC]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Biochemistry [q-bio.BM] ,Immunoassays ,Microbial Pathogens ,Viral Hemorrhagic Fevers ,Ebola virus ,business.industry ,Hemorrhagic Fever Viruses ,Public Health, Environmental and Occupational Health ,Organisms ,Outbreak ,Biology and Life Sciences ,Reproducibility of Results ,Hemorrhagic Fever, Ebola ,medicine.disease ,Tropical Diseases ,Virology ,030104 developmental biology ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Animal Genomics ,Amniotes ,Immunologic Techniques ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,Malaria - Abstract
Hemorrhagic fever outbreaks are difficult to diagnose and control in part because of a lack of low-cost and easily accessible diagnostic structures in countries where etiologic agents are present. Furthermore, initial clinical symptoms are common and shared with other endemic diseases such as malaria or typhoid fever. Current molecular diagnostic methods such as polymerase chain reaction require trained personnel and laboratory infrastructure, hindering diagnostics at the point of need, particularly in outbreak settings. Therefore, rapid diagnostic tests such as lateral flow can be broadly deployed and are typically well-suited to rapidly diagnose hemorrhagic fever viruses, such as Ebola virus. Early detection and control of Ebola outbreaks require simple, easy-to-use assays that can detect very low amount of virus in blood. Here, we developed and characterized an immunoassay test based on immunochromatography coupled to silver amplification technology to detect the secreted glycoprotein of EBOV. The glycoprotein is among the first viral proteins to be detected in blood. This strategy aims at identifying infected patients early following onset of symptoms by detecting low amount of sGP protein in blood samples. The limit of detection achieved by this sGP-targeted kit is 2.2 x 104 genome copies/ml in plasma as assayed in a monkey analytical cohort. Clinical performance evaluation showed a specificity of 100% and a sensitivity of 85.7% when evaluated with plasma samples from healthy controls and patients infected with Zaire Ebola virus from Macenta, Guinea. This rapid and accurate diagnostic test could therefore be used in endemic countries for early detection of infected individuals in point of care settings. Moreover, it could also support efficient clinical triage in hospitals or clinical centers and thus reducing transmission rates to prevent and better manage future severe outbreaks., Author summary Ebola virus disease is a severe disease caused by Ebola virus, a member of the filovirus family, which occurs in humans and other primates. Ebola is believed to be zoonotic, however the natural reservoir is unknown. Overlapping symptoms with other endemic diseases, such as malaria and cholera, make accurate diagnostic challenging. Outbreaks of Ebola have been widespread as the consequence of the absence of available rapid, sensitive, specific, robust, and affordable licensed diagnostic test in remote areas, where outbreaks usually start. Here we have established and validated a rapid diagnostic test, which is fast, sensitive, specific, efficient, affordable, and user-friendly. Its analytical characteristics make it suitable for clinical management during Ebola virus outbreaks in remote areas. Of interest, this rapid diagnostic test detects the presence of an early viral antigen, the secreted glycoprotein, found in blood of patients shortly after infection, suggesting that it could be used to identify infected patients shortly after onset of symptoms.
- Published
- 2020