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

Area of Science:

• Infectious Diseases
• Diagnostic Technologies
• Public Health

Background:

• Rapid and reliable laboratory diagnosis is crucial for controlling Ebola virus disease (EVD) transmission.
• Field-deployable diagnostic tools are essential for timely intervention in resource-limited settings.

Purpose of the Study:

• To evaluate the performance of the EBOLA Virus Antigen Detection K-SeT (EBOLA Ag K-SeT) in field conditions.
• To assess its utility as a rapid diagnostic tool for EVD.

Main Methods:

• The EBOLA Ag K-SeT was tested on 210 residual plasma samples from patients in Sierra Leone.
• Performance was compared against quantitative real-time PCR (qRT-PCR).
• Study conducted in a field laboratory by the Italian National Institute for Infectious Diseases and EMERGENCY Onlus NGO.

Main Results:

• Overall sensitivity was 88.6% (95% CI, 82.5-94.7) and specificity was 98.1% (95% CI, 95.5-100.7).
• Positive predictive value was 97.9% (95% CI, 95.0-100.8) and negative predictive value was 89.6% (95% CI, 84-95.2).
• Sensitivity increased to 98.7% (95% CI, 96.1-101.2) for samples with high viral load.

Conclusions:

• The EBOLA Ag K-SeT demonstrates potential as an effective diagnostic tool for EVD.
• It meets the need for rapid diagnosis in resource-poor settings.
• This test can aid in efficient interruption of EVD transmission chains.