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Sci Rep. 2018 Apr 12;8(1):5939. doi: 10.1038/s41598-018-24246-w.

Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever.

Author information

1
Zalgen Labs, LCC, Germantown, MD USA 20876 and Aurora, CO, 80013, Germantown, USA.
2
Tulane University, Department of Microbiology and Immunology, New Orleans, LA, 70112, USA.
3
Tulane University, School of Public Health and Tropical Medicine, New Orleans, LA, 70112, USA.
4
Viral Hemorrhagic Fever Program, Kenema Government Hospital, Kenema, Sierra Leone.
5
Ministry of Health and Sanitation, Freetown, Sierra Leone.
6
Eastern Polytechnic Institute, Kenema, Sierra Leone.
7
University of Texas Medical Branch, Galveston National Laboratory, Galveston, TX, USA.
8
Center for Systems Biology, Department of Organismic and Evolutionary Biology, Harvard University, Cambridge, Massachusetts, 02138, USA.
9
The Broad Institute of MIT and Harvard, Cambridge, Massachusetts, 02142, USA.
10
Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, 02115, USA.
11
Autoimmune Technologies, LLC, New Orleans, LA, USA.
12
Department of Immunology and Microbial Science, The Scripps Research Institute, La Jolla, California, 92037, USA.
13
Scripps Translational Science Institute, La Jolla, California, 92037, USA.
14
Department of Integrative Structural and Computational Biology, The Scripps Research Institute, La Jolla, California, 92037, USA.
15
Department of Biological Sciences, College of Natural Sciences, Redeemer's University, Ede, Osun State, Nigeria.
16
African Center of Excellence for genomics of Infectious Diseases, Redeemer's University, Ede, Osun State, Nigeria.
17
Howard Hughes Medical Institute, Chevy Chase, Maryland, 20815, USA.
18
The Skaggs Institute for Chemical Biology, The Scripps Research Institute, LaJolla, CA, USA.
19
Tulane University, Department of Pediatrics, Section of Infectious Diseases, New Orleans, LA, 70112, USA. jschieff@tulane.edu.
20
Zalgen Labs, LCC, Germantown, MD USA 20876 and Aurora, CO, 80013, Germantown, USA. lbranco@zalgenlabs.com.
21
Zalgen Labs, LCC, Germantown, MD USA 20876 and Aurora, CO, 80013, Germantown, USA. rfgarry@tulane.edu.
22
Tulane University, Department of Microbiology and Immunology, New Orleans, LA, 70112, USA. rfgarry@tulane.edu.

Abstract

Lassa fever, a hemorrhagic fever caused by Lassa virus (LASV), is endemic in West Africa. It is difficult to distinguish febrile illnesses that are common in West Africa from Lassa fever based solely on a patient's clinical presentation. The field performance of recombinant antigen-based Lassa fever immunoassays was compared to that of quantitative polymerase chain assays (qPCRs) using samples from subjects meeting the case definition of Lassa fever presenting to Kenema Government Hospital in Sierra Leone. The recombinant Lassa virus (ReLASV) enzyme-linked immunosorbant assay (ELISA) for detection of viral antigen in blood performed with 95% sensitivity and 97% specificity using a diagnostic standard that combined results of the immunoassays and qPCR. The ReLASV rapid diagnostic test (RDT), a lateral flow immunoassay based on paired monoclonal antibodies to the Josiah strain of LASV (lineage IV), performed with 90% sensitivity and 100% specificity. ReLASV immunoassays performed better than the most robust qPCR currently available, which had 82% sensitivity and 95% specificity. The performance characteristics of recombinant antigen-based Lassa virus immunoassays indicate that they can aid in the diagnosis of LASV Infection and inform the clinical management of Lassa fever patients.

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