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Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever

by Hartnett, Jessica N. , Siddle, Katherine J. , Kotliar, Dylan , Happi, Christian T. , Grant, Donald S. , Saphire, Erica Ollmann , Momoh, Mambu , Rowland, Megan M. , Lachenauer, Anna E. , Fonnie, Mbalu , Schieffelin, John S. , Winnicki, Sarah M. , Goba, Augustine , Nekoui, Mahan , Gbakie, Michael , Geisbert, Thomas W. , Shaffer, Jeffrey G. , Cross, Robert W. , Wilson, Russell B. , Kanneh, Lansana , Kulakosky, Peter C. , Boisen, Matthew L. , Koval, Anatoliy P. , Bush, Duane J. , Hastie, Kathryn M. , Sabeti, Pardis C. , Lin, Aaron E. , Folarin, Onikepe O. , Fullah, Mohamed , Khan, S. Humarr , Branco, Luis M. , Barnes, Kayla G. , Sandi, John Demby , Koroma, Veronica J. , Heinrich, Megan L. , Nelson, Diana K. S. , Garry, Robert F. , Andersen, Kristian G.

in 14/1 / 38/77 / 631/326/596/2562 / 692/308 / 82/16 / Africa, Western / Antibodies, Viral - genetics / Antibodies, Viral - immunology / Antigen presentation / Antigens / Antigens, Viral - genetics / Antigens, Viral - isolation & purification / Diagnosis / Enzyme-linked immunosorbent assay / Hemorrhage / Hemorrhagic fever / Humanities and Social Sciences / Humans / Immunoassay / Immunoassay - methods / Immunoassays / Immunoglobulin M - immunology / Lassa fever / Lassa Fever - diagnosis / Lassa Fever - immunology / Lassa Fever - virology / Lassa virus - immunology / Lassa virus - isolation & purification / Lassa virus - pathogenicity / Monoclonal antibodies / multidisciplinary / Recombinant Proteins - genetics / Recombinant Proteins - immunology / Science / Science (multidisciplinary) / Sierra Leone / Validation Studies as Topic

2018

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2018

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2018

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Journal Article

Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever

Hartnett, Jessica N.,

Siddle, Katherine J.,

Kotliar, Dylan,

Happi, Christian T.,

Grant, Donald S.,

Saphire, Erica Ollmann,

Momoh, Mambu,

Rowland, Megan M.,

Lachenauer, Anna E.,

Fonnie, Mbalu,

Schieffelin, John S.,

Winnicki, Sarah M.,

Goba, Augustine,

Nekoui, Mahan,

Gbakie, Michael,

Geisbert, Thomas W.,

Shaffer, Jeffrey G.,

Cross, Robert W.,

Wilson, Russell B.,

Kanneh, Lansana,

Kulakosky, Peter C.,

Boisen, Matthew L.,

Koval, Anatoliy P.,

Bush, Duane J.,

Hastie, Kathryn M.,

Sabeti, Pardis C.,

Lin, Aaron E.,

Folarin, Onikepe O.,

Fullah, Mohamed,

Khan, S. Humarr,

Branco, Luis M.,

Barnes, Kayla G.,

Sandi, John Demby,

Koroma, Veronica J.,

Heinrich, Megan L.,

Nelson, Diana K. S.,

Garry, Robert F.,

Andersen, Kristian G.

2018

Overview

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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Publisher

Nature Publishing Group UK,Nature Publishing Group

Subject

14/1

/ 38/77

/ 631/326/596/2562

/ 692/308

/ 82/16

/ Africa, Western

/ Antibodies, Viral - genetics