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

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.

SUBMITTER: Boisen ML

PROVIDER: S-EPMC5897328 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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

Boisen Matthew L ML Hartnett Jessica N JN Shaffer Jeffrey G JG Goba Augustine A Momoh Mambu M Sandi John Demby JD Fullah Mohamed M Nelson Diana K S DKS Bush Duane J DJ Rowland Megan M MM Heinrich Megan L ML Koval Anatoliy P AP Cross Robert W RW Barnes Kayla G KG Lachenauer Anna E AE Lin Aaron E AE Nekoui Mahan M Kotliar Dylan D Winnicki Sarah M SM Siddle Katherine J KJ Gbakie Michael M Fonnie Mbalu M Koroma Veronica J VJ Kanneh Lansana L Kulakosky Peter C PC Hastie Kathryn M KM Wilson Russell B RB Andersen Kristian G KG Folarin Onikepe O OO Happi Christian T CT Sabeti Pardis C PC Geisbert Thomas W TW Saphire Erica Ollmann EO Khan S Humarr SH Grant Donald S DS Schieffelin John S JS Branco Luis M LM Garry Robert F RF

Scientific reports 20180412 1

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 Si ...[more]

PMID: 29651117

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Project description:BackgroundWildebeest associated malignant catarrhal fever (WA-MCF) is a fatal disease of cattle. Outbreaks are seasonal and associated with close interaction between cattle and calving wildebeest. In Kenya, WA-MCF has a dramatic effect on cattle-keepers who lose up to 10% of their cattle herds per year. The objective of this study was to report the impact of WA-MCF on a commercial ranch and assess the performance of clinical diagnosis compared to laboratory diagnosis as a disease management tool. A retrospective study of WA-MCF in cattle was conducted from 2014 to 2016 at Kapiti Plains Ranch Ltd., Kenya. During this period, 325 animals showed clinical signs of WA-MCF and of these, 123 were opportunistically sampled. In addition, 51 clinically healthy animals were sampled. Nested polymerase chain reaction (PCR) and indirect enzyme linked immunosorbent assay (ELISA) were used to confirm clinically diagnosed cases of WA-MCF. A latent class model (LCM) was used to evaluate the diagnostic parameters of clinical diagnosis and the tests in the absence of a gold standard.ResultsBy PCR, 94% (95% C.I. 89-97%) of clinically affected animals were positive to WA-MCF while 63% (95% C.I. 54-71%) were positive by indirect ELISA. The LCM demonstrated the indirect ELISA had poor sensitivity 63.3% (95% PCI 54.4-71.7%) and specificity 62.6% (95% PCI 39.2-84.9%) while the nested PCR performed better with sensitivity 96.1% (95% PCI 90.7-99.7%) and specificity 92.9% (95% PCI 76.1-99.8%). The sensitivity and specificity of clinical diagnosis were 99.1% (95% PCI 96.8-100.0%) and 71.5% (95% PCI 48.0-97.2%) respectively.ConclusionsClinical diagnosis was demonstrated to be an effective method to identify affected animals although animals may be incorrectly classified resulting in financial loss. The study revealed indirect ELISA as a poor test and nested PCR to be a more appropriate confirmatory test for diagnosing acute WA-MCF. However, the logistics of PCR make it unsuitable for field diagnosis of WA-MCF. The future of WA-MCF diagnosis should be aimed at development of penside techniques, which will allow for fast detection in the field.

Dataset Information

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

Publications

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

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