Clinical Evaluation of QuickNaviTM-Ebola in the 2018 Outbreak of Ebola Virus Disease in the Democratic Republic of the Congo

Sheila Makiala; Daniel Mukadi; Anja De Weggheleire; Shino Muramatsu; Daisuke Kato; Koichi Inano; Fumio Gondaira; Masahiro Kajihara; Reiko Yoshida; Katendi Changula; Aaron Mweene; Placide Mbala-Kingebeni; Jean-Jacques Muyembe-Tamfum; Justin Masumu; Steve Ahuka; Ayato Takada

doi:10.3390/v11070589

Clinical Evaluation of QuickNavi^TM-Ebola in the 2018 Outbreak of Ebola Virus Disease in the Democratic Republic of the Congo

Viruses. 2019 Jun 28;11(7):589. doi: 10.3390/v11070589.

Authors

Sheila Makiala^{1

2}, Daniel Mukadi^{1

2}, Anja De Weggheleire^{3

4}, Shino Muramatsu⁵, Daisuke Kato⁵, Koichi Inano⁵, Fumio Gondaira⁵, Masahiro Kajihara⁶, Reiko Yoshida⁶, Katendi Changula^{7

8}, Aaron Mweene^{7

8}, Placide Mbala-Kingebeni^{1

2}, Jean-Jacques Muyembe-Tamfum^{1

2}, Justin Masumu¹, Steve Ahuka^{1

2}, Ayato Takada^{9

10

11

12}

Affiliations

¹ Institut National de Recherche Biomédicale, Avenue de la Démocratie, Kinshasa/Gombe-P.O. Box 1197, Kinshasa I, Democratic Republic of the Congo.
² Service de Microbiologie, Cliniques Universitaires de Kinshasa, Kinshasa, Democratic Republic of the Congo.
³ Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
⁴ Outbreak Research team, Institute of Tropical Medicine, Antwerp, Belgium.
⁵ Denka Seiken Co., Ltd., 1359-1, Kagamida, Kigoshi, Gosen, Niigata 959-1695, Japan.
⁶ Division of Global Epidemiology, Research Center for Zoonosis Control, Hokkaido University, Kita-20, Nishi-10, Kita-ku, Sapporo 001-0020, Japan.
⁷ School of Veterinary Medicine, the University of Zambia, Great East Road Campus, Lusaka, Zambia.
⁸ Africa Center of Excellence for Infectious Diseases of Humans and Animals, the University of Zambia, Lusaka, Zambia.
⁹ Division of Global Epidemiology, Research Center for Zoonosis Control, Hokkaido University, Kita-20, Nishi-10, Kita-ku, Sapporo 001-0020, Japan. [email protected].
¹⁰ School of Veterinary Medicine, the University of Zambia, Great East Road Campus, Lusaka, Zambia. [email protected].
¹¹ Africa Center of Excellence for Infectious Diseases of Humans and Animals, the University of Zambia, Lusaka, Zambia. [email protected].
¹² Global Station for Zoonosis Control, Global Institution for Collaborative Research and Education, Hokkaido University, Kita-20, Nishi-10, Kita-ku, Sapporo 001-0020, Japan. [email protected].

Abstract

The recent large outbreaks of Ebola virus disease (EVD) in West Africa and the Democratic Republic of the Congo (DRC) have highlighted the need for rapid diagnostic tests to control this disease. In this study, we clinically evaluated a previously developed immunochromatography-based kit, QuickNavi^TM-Ebola. During the 2018 outbreaks in DRC, 928 blood samples from EVD-suspected cases were tested with QuickNavi^TM-Ebola and the WHO-approved GeneXpert. The sensitivity and specificity of QuickNavi^TM-Ebola, estimated by comparing it to GeneXpert-confirmed cases, were 85% (68/80) and 99.8% (846/848), respectively. These results indicate the practical reliability of QuickNavi^TM-Ebola for point-of-care diagnosis of EVD.

Keywords: DRC; EVD; Ebola virus; QuickNavi; immunochromatography; rapid diagnostic test.

Publication types

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

MeSH terms

Chromatography, Affinity / methods*
Democratic Republic of the Congo / epidemiology
Disease Outbreaks
Ebolavirus / genetics
Ebolavirus / isolation & purification*
Hemorrhagic Fever, Ebola / diagnosis*
Hemorrhagic Fever, Ebola / virology
Humans
Reagent Kits, Diagnostic
Sensitivity and Specificity

Substances

Reagent Kits, Diagnostic