title: Lateral Flow Immunoassays for Ebola Virus Disease Detection in Liberia.
abstract: Lateral flow immunoassays (LFIs) are point-of-care diagnostic assays that are designed for single use outside a formal laboratory, with in-home pregnancy tests the best-known example of these tests. Although the LFI has some limitations over more-complex immunoassay procedures, such as reduced sensitivity and the potential for false-positive results when using complex sample matrices, the assay has the benefits of a rapid time to result and ease of use. These benefits make it an attractive option for obtaining rapid results in an austere environment. In an outbreak of any magnitude, a field-based rapid diagnostic assay would allow proper patient transport and for safe burials to be conducted without the delay caused by transport of samples between remote villages and testing facilities. Use of such point-of-care instruments in the ongoing Ebola virus disease (EVD) outbreak in West Africa would have distinct advantages in control and prevention of local outbreaks, but proper understanding of the technology and interpretation of results are important.
  
  
  
  In this study, a LFI, originally developed by the Naval Medical Research Center for Ebola virus environmental testing, was evaluated for its ability to detect the virus in clinical samples in Liberia. Clinical blood and plasma samples and post mortem oral swabs submitted to the Liberian Institute for Biomedical Research, the National Public Health Reference Laboratory for EVD testing, were tested and compared to results of real-time reverse transcription-polymerase chain reaction (rRT-PCR), using assays targeting Ebola virus glycoprotein and nucleoprotein.
  
  
  
  The LFI findings correlated well with those of the real-time RT-PCR assays used as benchmarks.
  
  
  
  Rapid antigen-detection tests such as LFIs are attractive alternatives to traditional immunoassays but have reduced sensitivity and specificity, resulting in increases in false-positive and false-negative results. An understanding of the strengths, weaknesses, and limitations of a particular assay lets the diagnostician choose the correct situation to use the correct assay and properly interpret the results.
authors.affiliation: Biological Defense Research Directorate, Naval Medical Research Center.
authors.forename: Jill C
authors.initials: JC
authors.lastname: Phan
authors.affiliation: Integrated Research Facility, National Institutes of Health.
authors.forename: James
authors.initials: J
authors.lastname: Pettitt
authors.affiliation: Liberian Institute for Biomedical Research, Charlesville.
authors.forename: Josiah S
authors.initials: JS
authors.lastname: George
authors.affiliation: Liberian Institute for Biomedical Research, Charlesville.
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Fakoli
authors.affiliation: Liberian Institute for Biomedical Research, Charlesville.
authors.forename: Fahn M
authors.initials: FM
authors.lastname: Taweh
authors.affiliation: US Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland.
authors.forename: Stacey L
authors.initials: SL
authors.lastname: Bateman
authors.affiliation: Integrated Research Facility, National Institutes of Health.
authors.forename: Richard S
authors.initials: RS
authors.lastname: Bennett
authors.affiliation: US Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Norris
authors.affiliation: Biological Defense Research Directorate, Naval Medical Research Center.
authors.forename: David A
authors.initials: DA
authors.lastname: Spinnler
authors.affiliation: Biological Defense Research Directorate, Naval Medical Research Center.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Pimentel
authors.affiliation: Liberian Institute for Biomedical Research, Charlesville.
authors.forename: Phillip K
authors.initials: PK
authors.lastname: Sahr
authors.affiliation: Liberian Institute for Biomedical Research, Charlesville.
authors.forename: Fatorma K
authors.initials: FK
authors.lastname: Bolay
authors.affiliation: US Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland.
authors.forename: Randal J
authors.initials: RJ
authors.lastname: Schoepp
mesh_terms: D004196:Disease Outbreaks; D029043:Ebolavirus / Q000276:immunology* / Q000302:isolation & purification; D006023:Glycoproteins / Q000276:immunology; D019142:Hemorrhagic Fever, Ebola / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007988:Liberia / Q000453:epidemiology; D009698:Nucleoproteins / Q000276:immunology; D019095:Point-of-Care Systems; D011634:Public Health; D060888:Real-Time Polymerase Chain Reaction; D012680:Sensitivity and Specificity
chemical_list: D006023:Glycoproteins; D009698:Nucleoproteins
keywords: EBOV; EVD; Ebola; Ebola virus disease; LFI; Liberia; West Africa; antibodies; diagnostics; immunoassay; lateral flow