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.
Highlights
Lassa fever is a viral hemorrhagic fever (VHF) that is endemic in Sierra Leone, Guinea, Liberia and Nigeria, with cases reported in several other West African countries[1,2,3,4,5]
Lassa virus (LASV) IgM and IgG capture enzyme-linked immunosorbant assay (ELISA) utilize microwell plates coated with recombinant LASV (ReLASV) nucleoprotein (NP), glycoprotein complex (GPC), and Z matrix protein or with NP alone[37,38]
The recombinant Lassa virus (ReLASV) NP has been used as an immunogen to produce monoclonal antibodies (MAbs) in mice and polyclonal antibodies (PAbs) in animals of various species
Summary
Lassa fever is a viral hemorrhagic fever (VHF) that is endemic in Sierra Leone, Guinea, Liberia and Nigeria, with cases reported in several other West African countries[1,2,3,4,5]. Women who are pregnant develop severe disease with increased frequency and have a Lassa fever CFR as high as 90%, with fetal death, miscarriage or spontaneous abortion occurring in most cases[1,14,15]. Rapid diagnosis of LASV infection is imperative for proper patient management, which includes patient isolation, treatment with ribavirin when available, and supportive care such as the replacement of fluids and electrolytes. While reverse transcriptase-polymerase chain reaction (RT-PCR) assays to detect LASV RNA can be used to diagnose Lassa fever[30,31,32,33], the capacity to provide such testing as a routine method in rural public healthcare units (PHUs) in endemic regions of West Africa is limited at the present time. We compare the performance of Lassa fever immunodiagnostic assays based on recombinant Lassa virus (LASV) proteins, including a rapid diagnostic test (RDT), to available quantitative PCR (qPCR) assays
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