F Colavita1, M Biava1, P Mertens2, Q Gilleman2, C Borlon2, M Delli Guanti3, A Petrocelli3, G Cataldi3, A T Kamara4, S A Kamara4, K Konneh4, D Vincenti1, C Castilletti1, S Abdurahman5, A Mirazimi6, M R Capobianchi1, G Ippolito1, R Miccio3, A Di Caro7. 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.
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.
Authors: Basilua Andre Muzembo; Kei Kitahara; Ayumu Ohno; Ngangu Patrick Ntontolo; Nlandu Roger Ngatu; Keinosuke Okamoto; Shin-Ichi Miyoshi Journal: Bull World Health Organ Date: 2022-06-01 Impact factor: 13.831