Field Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

Journal of Infectious Diseases

Volumn 214, Issue , 2016, Pages S203-S209

  Boisen, Matthew L ^a,b   Cross, Robert W ^e   Hartnett, Jessica N ^b   Goba, Augustine ^g,i   Momoh, Mambu ^g,h,i   Fullah, Mohamed ^g,i   Gbakie, Michael ^g,i   Safa, Sidiki ^g,i   Fonnie, Mbalu ^g,i   Baimba, Francis ^g,i   Koroma, Veronica J ^g,i   Geisbert, Joan B ^e   McCormick, Stephanie ^c   Nelson, DIana K S ^a   Millett, Molly M ^a   Oottamasathien, Darin ^a   Jones, Abby B ^a   Pham, Ha ^a   Brown, Bethany L ^a   Shaffer, Jeffrey G ^d   Schieffelin, John S ^b   Kargbo, Brima ⁱ   Gbetuwa, Momoh ^g   Gevao, Sahr M ^g,h,i   Wilson, Russell B ^c   Pitts, Kelly R ^a   Geisbert, Thomas W ^e   Branco, Luis M ^f   Khan, Sheik H ^g,i   Grant, Donald S ^g,i   Garry, Robert F ^b,f   more..

^a Colorado ^*  (United States)

^b TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Autoimmune Technologies LLC   (United States)

^d TULANE UNIVERSITY   (United States)

^e UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^f Zalgen Labs   (United States)

^g Kenema Government Hospital   (Sierra Leone)

^h Eastern Technical University   (Sierra Leone)

ⁱ MINISTRY OF HEALTH AND SANITATION   (Sierra Leone)

Author keywords

Clinical; Ebola; Lateral flow immunoassay; Point of care; Validation

Indexed keywords

CONFERENCE PAPER; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DIAGNOSTIC VALUE; EBOLA HEMORRHAGIC FEVER; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; MAJOR CLINICAL STUDY; POINT OF CARE TESTING; PREDICTIVE VALUE; PRIORITY JOURNAL; RAPID TEST; RECEIVER OPERATING CHARACTERISTIC; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY; BLOOD; DIAGNOSTIC KIT; EBOLAVIRUS; GENETICS; HEMORRHAGIC FEVER, EBOLA; HOSPITAL; IMMUNOASSAY; IMMUNOLOGY; ISOLATION AND PURIFICATION; POINT OF CARE SYSTEM; PROCEDURES; REAL TIME POLYMERASE CHAIN REACTION; REPRODUCIBILITY; SIERRA LEONE; VIROLOGY;

DIAGNOSTIC KIT; VIRUS ANTIGEN; VIRUS RNA;

ANTIGENS, VIRAL; EBOLAVIRUS; HEMORRHAGIC FEVER, EBOLA; HOSPITALS; HUMANS; IMMUNOASSAY; POINT-OF-CARE SYSTEMS; REAGENT KITS, DIAGNOSTIC; REAL-TIME POLYMERASE CHAIN REACTION; REPRODUCIBILITY OF RESULTS; RNA, VIRAL; SENSITIVITY AND SPECIFICITY; SIERRA LEONE;

EID: 84990902989     PISSN: 00221899     EISSN: 15376613     Source Type: Journal    
DOI: 10.1093/infdis/jiw261     Document Type: Conference Paper

References (27)

1. Georges AJ, Leroy EM, Renaut AA, et al. Ebola Hemorrhagic Fever Outbreaks in Gabon, 1994-1997: Epidemiologic and Health Control Issues. J Infect Dis 1999; 179(suppl 1):S65-75.
2. Leroy EM, Epelboin A, Mondonge V, et al. Human Ebola outbreak resulting from direct exposure to fruit bats in Luebo, Democratic Republic of Congo, 2007. Vector Borne Zoonotic Dis 2009; 9:723-8.
3. Mylne AQ, Pigott DM, Longbottom J, et al. Mapping the zoonotic niche of Lassa fever in Africa. Trans R Soc Trop Med Hyg 2015; 109:483-92.
4. Pigott DM, Golding N, Mylne A, et al. Mapping the zoonotic niche of Ebola virus disease in Africa. Elife 2014; 3:e04395.
5. Johnson KM, McCormick JB, Webb PA, Smith ES, Elliott LH, King IJ. Clinical virology of Lassa fever in hospitalized patients. J Infect Dis 1987; 155:456-64.
6. Shaffer JG, Grant DS, Schieffelin JS, et al. Lassa Fever in Post-Conflict Sierra Leone. PLoS Negl Trop Dis 2014; 8:e2748.
7. Schieffelin JS, Shaffer JG, Goba A, et al. Clinical illness and outcomes in patients with Ebola in Sierra Leone. N Engl J Med 2014; 371:2092-100.
8. Yun NE, Walker DH. Pathogenesis of Lassa fever. Viruses 2012; 4:2031-48.
9. Hunt L, Gupta-Wright A, Simms V, et al. Clinical presentation, biochemical, and haematological parameters and their association with outcome in patients with Ebola virus disease: an observational cohort study. Lancet Infect Dis 2015; 15:1292-9.
10. Arwady MA, Bawo L, Hunter JC, et al. Evolution of ebola virus disease from exotic infection to global health priority, Liberia, mid-2014. Emerg Infect Dis 2015; 21:578-84.
11. Petti S, Messano GA, Vingolo EM, Marsella LT, Scully C. The face of Ebola: changing frequency of haemorrhage in theWest African compared with Eastern-Central African outbreaks. BMC Infect Dis 2015; 15:564.
12. Takada A, Kawaoka Y. The pathogenesis of Ebola hemorrhagic fever. Trends Microbiol 2001; 9:506-11.
13. Vogt F, Fitzpatrick G, Patten G, et al. Assessment of the MSF triage system, separating patients into different wards pending Ebola virus laboratory confirmation, Kailahun, Sierra Leone, July to September 2014. Euro Surveill 2015; doi:10.2807/1560-7917.ES.2015.20.50.30097.
14. Lado M,Walker NF, Baker P, et al. Clinical features of patients isolated for suspected Ebola virus disease at Connaught Hospital, Freetown, Sierra Leone: a retrospective cohort study. Lancet Infect Dis 2015; 15:1024-33.
15. WHO. Target Product Profile for Zaire ebolavirus rapid, simple test to be used in the control of the Ebola outbreak in West Africa 2014.
16. Schieffelin J, Moses LM, Shaffer J, Goba A, Grant DS. Clinical validation trial of a diagnostic for Ebola Zaire antigen detection: Design rationale and challenges to implementation. Clin Trials 2016; 13:66-72.
17. WHO. EVD Case definition, 2014.
18. WHO. Personal protective equipment in the context of filovirus disease outbreak response, 2014.
19. Trombley AR,Wachter L, Garrison J, et al. Comprehensive panel of real-time Taq-Man polymerase chain reaction assays for detection and absolute quantification of filoviruses, arenaviruses, and NewWorld hantaviruses. Am J Trop Med Hyg 2010; 82:954-60.
20. FDA U. Statistical Guide on Reporting Results from Studies Evaluating Diagnostic Tests, 2007.
21. CLSI. User Protocol for Evaluation of Evaluation of Qualitative Test Performance: Approved Guideline-Second Edition, 2008; EP12-A2.
22. Crowe SJ, Maenner MJ, Kuah S, et al. Prognostic indicators for Ebola patient survival. Emerg Infect Dis 2016; 22:217-23.
23. de La Vega MA, Caleo G, Audet J, et al. Ebola viral load at diagnosis associates with patient outcome and outbreak evolution. J Clin Invest 2015; 125:4421-8.
24. Broadhurst MJ. ReEBOVAntigen Rapid Test kit for point-of-care and laboratorybased testing for Ebola virus disease: a field validation study, 2015.
25. Fitzpatrick G, Vogt F, Moi Gbabai OB, et al. The contribution of Ebola viral load at admission and other patient characteristics to mortality in a Medecins Sans Frontieres Ebola case management centre, Kailahun, Sierra Leone, June-October 2014. J Infect Dis 2015; 212:1752-8.
26. Fitzpatrick G, Vogt F, Moi Gbabai OB, et al. Describing readmissions to an Ebola case management centre (CMC), Sierra Leone, 2014. Euro Surveill 2014; 19: pii:20924.
27. Nouvellet P, Garske T, Mills HL, et al. The role of rapid diagnostics in managing Ebola epidemics. Nature 2015; 528:S109-16.