title: Field Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection.
abstract: The 2013-2016 West African Ebola virus disease (EVD) epidemic is the largest recorded. Triage on the basis of clinical signs had limited success, and the time to diagnosis by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) could exceed 5 days. Here we describe the development and field validation of the ReEBOV Antigen Rapid Test (ReEBOV RDT) to aid triage of individuals with suspected EVD.
  
  
  
  Samples from patients with suspected EVD were submitted to Kenema Government Hospital, Sierra Leone, for Lassa fever and EVD screening throughout 2014. Banked residual clinical samples were tested in November 2014 and January 2015 in a blinded field trial to estimate the clinical effectiveness of the ReEBOV RDT, compared with EBOV-specific qRT-PCR.
  
  
  
  Preliminary ReEBOV RDT performance demonstrated a positive percentage agreement (PPA) of 91.1% (195 of 214 results; 95% confidence interval [CI], 86.5%-94.6%) and a negative percentage agreement (NPA) of 90.2% (175 of 194; 95% CI, 85.1%-94.0%). The final estimates used by the Food and Drug Administration to determine whether to grant emergency use authorization for the test, which excluded a qRT-PCR reference method threshold cutoff, were a PPA of 62.1% (72 of 116 results; 95% CI, 52.6%-70.9%) and a NPA of 96.7% (58 of 60; 95% CI, 88.5%-99.6%), with a diagnostic likelihood of 18.6. A subsequent, independent evaluation by the World Health Organization generated results consistent with the preliminary performance estimates.
  
  
  
  The ReEBOV RDT demonstrated the potential to provide clinically effective rapid and accurate point-of-care test results and, thus, to be a powerful tool for increasing triage efficiency.
authors: Corgenix, Broomfield, Colorado Department of Microbiology and Immunology.
authors: Matthew L
authors: ML
authors: Boisen
authors: Galveston National Laboratory, University of Texas Medical Branch.
authors: Robert W
authors: RW
authors: Cross
authors: Department of Microbiology and Immunology.
authors: Jessica N
authors: JN
authors: Hartnett
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Augustine
authors: A
authors: Goba
authors: Lassa Fever Program, Kenema Government Hospital Eastern Polytechnic Institute, Kenema Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Mambu
authors: M
authors: Momoh
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Mohamed
authors: M
authors: Fullah
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Michael
authors: M
authors: Gbakie
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Sidiki
authors: S
authors: Safa
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Mbalu
authors: M
authors: Fonnie
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Francis
authors: F
authors: Baimba
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Veronica J
authors: VJ
authors: Koroma
authors: Galveston National Laboratory, University of Texas Medical Branch.
authors: Joan B
authors: JB
authors: Geisbert
authors: Autoimmune Technologies.
authors: Stephanie
authors: S
authors: McCormick
authors: Corgenix, Broomfield, Colorado.
authors: Diana K S
authors: DK
authors: Nelson
authors: Corgenix, Broomfield, Colorado.
authors: Molly M
authors: MM
authors: Millett
authors: Corgenix, Broomfield, Colorado.
authors: Darin
authors: D
authors: Oottamasathien
authors: Corgenix, Broomfield, Colorado.
authors: Abby B
authors: AB
authors: Jones
authors: Corgenix, Broomfield, Colorado.
authors: Ha
authors: H
authors: Pham
authors: Corgenix, Broomfield, Colorado.
authors: Bethany L
authors: BL
authors: Brown
authors: Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.
authors: Jeffrey G
authors: JG
authors: Shaffer
authors: Department of Pediatrics, Section of Infectious Diseases, Tulane University.
authors: John S
authors: JS
authors: Schieffelin
authors: Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Brima
authors: B
authors: Kargbo
authors: Lassa Fever Program, Kenema Government Hospital.
authors: Momoh
authors: M
authors: Gbetuwa
authors: Lassa Fever Program, Kenema Government Hospital Eastern Polytechnic Institute, Kenema Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Sahr M
authors: SM
authors: Gevao
authors: Autoimmune Technologies.
authors: Russell B
authors: RB
authors: Wilson
authors: Corgenix, Broomfield, Colorado.
authors: Kelly R
authors: KR
authors: Pitts
authors: Galveston National Laboratory, University of Texas Medical Branch.
authors: Thomas W
authors: TW
authors: Geisbert
authors: Zalgen Labs, Germantown, Maryland.
authors: Luis M
authors: LM
authors: Branco
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Sheik H
authors: SH
authors: Khan
authors: Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors: Donald S
authors: DS
authors: Grant
authors: Department of Microbiology and Immunology Zalgen Labs, Germantown, Maryland.
authors: Robert F
authors: RF
authors: Garry
mesh_terms: D000956:Antigens, Viral / Q000097:blood*; D029043:Ebolavirus / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification; D019142:Hemorrhagic Fever, Ebola / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D006761:Hospitals; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D019095:Point-of-Care Systems; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012807:Sierra Leone
chemical_list: D000956:Antigens, Viral; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: Ebola; clinical; lateral flow immunoassay; point of care; validation