Characterization and analytical validation of a new antigenic rapid diagnostic test for Ebola virus disease detection

PLoS Negl Trop Dis. 2020 Jan 17;14(1):e0007965. doi: 10.1371/journal.pntd.0007965. eCollection 2020 Jan.

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Antigens, Viral / isolation & purification*
  • Ebolavirus / immunology
  • Ebolavirus / isolation & purification*
  • Hemorrhagic Fever, Ebola / diagnosis*
  • Humans
  • Immunoassay* / methods
  • Immunoassay* / standards
  • Point-of-Care Systems
  • Reproducibility of Results

Substances

  • Antigens, Viral

Grants and funding

This work is a collaborative project between BIOASTER and FUJIFILM. 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. The objective of the study and the study design has been defined commonly by BIOASTER and FUJIFILM. The French Government had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.