Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever

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

doi:10.1038/s41598-018-24246-w

Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever

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

Microbiology And Immunology

Research output: Contribution to journal › Article › peer-review

37 Scopus citations

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.

Original language	English (US)
Article number	5939
Journal	Scientific reports
Volume	8
Issue number	1
DOIs	https://doi.org/10.1038/s41598-018-24246-w
State	Published - Dec 1 2018

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Boisen, M. L., Hartnett, J. N., Shaffer, J. G., Goba, A., Momoh, M., Sandi, J. D., Fullah, M., Nelson, D. K. S., Bush, D. J., Rowland, M. M., Heinrich, M. L., Koval, A. P., Cross, R. W., Barnes, K. G., Lachenauer, A. E., Lin, A. E., Nekoui, M., Kotliar, D., Winnicki, S. M., ... Garry, R. F. (2018). Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever. Scientific reports, 8(1), Article 5939. https://doi.org/10.1038/s41598-018-24246-w

Boisen, ML, Hartnett, JN, Shaffer, JG, Goba, A, Momoh, M, Sandi, JD, Fullah, M, Nelson, DKS, Bush, DJ, Rowland, MM, Heinrich, ML, Koval, AP, Cross, RW, Barnes, KG, Lachenauer, AE, Lin, AE, Nekoui, M, Kotliar, D, Winnicki, SM, Siddle, KJ, Gbakie, M, Fonnie, M, Koroma, VJ, Kanneh, L, Kulakosky, PC, Hastie, KM, Wilson, RB, Andersen, KG, Folarin, OO, Happi, CT, Sabeti, PC, Geisbert, TW, Saphire, EO, Khan, SH, Grant, DS, Schieffelin, JS, Branco, LM & Garry, RF 2018, 'Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever', Scientific reports, vol. 8, no. 1, 5939. https://doi.org/10.1038/s41598-018-24246-w

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title = "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.",

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

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doi = "10.1038/s41598-018-24246-w",

language = "English (US)",

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T1 - Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever

AU - Boisen, Matthew L.

AU - Hartnett, Jessica N.

AU - Shaffer, Jeffrey G.

AU - Goba, Augustine

AU - Momoh, Mambu

AU - Sandi, John Demby

AU - Fullah, Mohamed

AU - Nelson, Diana K.S.

AU - Bush, Duane J.

AU - Rowland, Megan M.

AU - Heinrich, Megan L.

AU - Koval, Anatoliy P.

AU - Cross, Robert W.

AU - Barnes, Kayla G.

AU - Lachenauer, Anna E.

AU - Lin, Aaron E.

AU - Nekoui, Mahan

AU - Kotliar, Dylan

AU - Winnicki, Sarah M.

AU - Siddle, Katherine J.

AU - Gbakie, Michael

AU - Fonnie, Mbalu

AU - Koroma, Veronica J.

AU - Kanneh, Lansana

AU - Kulakosky, Peter C.

AU - Hastie, Kathryn M.

AU - Wilson, Russell B.

AU - Andersen, Kristian G.

AU - Folarin, Onikepe O.

AU - Happi, Christian T.

AU - Sabeti, Pardis C.

AU - Geisbert, Thomas W.

AU - Saphire, Erica Ollmann

AU - Khan, S. Humarr

AU - Grant, Donald S.

AU - Schieffelin, John S.

AU - Branco, Luis M.

AU - Garry, Robert F.

PY - 2018/12/1

Y1 - 2018/12/1

N2 - 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.

AB - 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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Field validation of recombinant antigen immunoassays for diagnosis of Lassa fever

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