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Clin Microbiol Infect. 2018 Jun;24(6):653-657. doi: 10.1016/j.cmi.2017.10.019. Epub 2017 Oct 26.

EBOLA Ag K-SeT rapid test: field evaluation in Sierra Leone.

Author information

1
National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy.
2
Coris BioConcept, Gembloux, Belgium.
3
EMERGENCY Onlus NGO, Milan, Italy.
4
EMERGENCY Onlus NGO, Milan, Italy; Diagnostic Ebola Virus Diseases Laboratory, 'Princess Christian Maternity Hospital', Freetown, Sierra Leone.
5
Public Health Agency of Sweden, Stockholm, Sweden.
6
Public Health Agency of Sweden, Stockholm, Sweden; National Veterinary Institute, Uppsala, Sweden; Department of Medicine, Karolinska Institute, Stockholm, Sweden.
7
National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy. Electronic address: antonino.dicaro@inmi.it.

Abstract

OBJECTIVES:

Efficient interruption of Ebola virus disease (EVD) transmission chains critically depends on reliable and fast laboratory diagnosis. We evaluated the performance of the EBOLA Virus Antigen Detection K-SeT (EBOLA Ag K-SeT), a new rapid diagnostic antigen test in field settings.

METHODS:

The study was conducted in a field laboratory located in Freetown (Sierra Leone) by the Italian National Institute for Infectious Diseases 'L. Spallanzani' and the EMERGENCY Onlus NGO. The EBOLA Ag K-SeT was tested on 210 residual plasma samples (EVD prevalence 50%) from patients hospitalized at the EMERGENCY Ebola treatment center in Goderich (Freetown), comparing the results with quantitative real-time PCR.

RESULTS:

Overall, the sensitivity of EBOLA Ag K-SeT was 88.6% (95% confidence interval (CI), 82.5-94.7), and the corresponding specificity was 98.1% (95% CI, 95.5-100.7). The positive and negative predictive values were 97.9% (95% CI, 95.0-100.8) and 89.6% (95% CI, 84-95.2), respectively. The sensitivity strongly increased up to 98.7% (95% CI, 96.1-101.2) for those samples with high virus load (≥6.2 log RNA copies/mL).

CONCLUSIONS:

Our results suggest that EBOLA Ag K-SeT could represent a new effective diagnostic tool for EVD, meeting a need for resource-poor settings and rapid diagnosis for individuals with suspected EVD.

KEYWORDS:

Antigen detection; Ebola virus disease; Point of care; Rapid diagnostic test; Western Africa

PMID:
29107122
DOI:
10.1016/j.cmi.2017.10.019
[Indexed for MEDLINE]

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