Performance of the GeneXpert Ebola Assay for Diagnosis of Ebola Virus Disease in Sierra Leone: A Field Evaluation Study

PLoS Medicine

Volumn 13, Issue 3, 2016, Pages

  Semper, Amanda E ^a   Broadhurst, M Jana ^b   Richards, Jade ^c,d   Foster, Geraldine M ^c,e   Simpson, Andrew J H ^a,c   Logue, Christopher H ^a   Kelly, J Daniel ^f   Miller, Ann ^b,g   Brooks, Tim J G ^a,c   Murray, Megan ^b,g   Pollock, Nira R ^b,h  

^a PUBLIC HEALTH ENGLAND   (United Kingdom)

^b PARTNERS IN HEALTH   (United States)

^c Public Health England Laboratory   (Sierra Leone)

^d BASILDON HOSPITAL   (United Kingdom)

^e LIVERPOOL SCHOOL OF TROPICAL MEDICINE   (United Kingdom)

^f Wellbody Alliance   (Sierra Leone)

^g HARVARD MEDICAL SCHOOL   (United States)

^h BOSTON CHILDREN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ADULT; AGED; ARTICLE; CHILD; CONTROLLED STUDY; EBOLA HEMORRHAGIC FEVER; FEMALE; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; RAPID TEST; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; BLOOD; EBOLAVIRUS; GENETICS; HEMORRHAGIC FEVER, EBOLA; MIDDLE AGED; POINT OF CARE SYSTEM; PRESCHOOL CHILD; PROCEDURES; REAL TIME POLYMERASE CHAIN REACTION; SIERRA LEONE; VERY ELDERLY; YOUNG ADULT;

GLYCOPROTEIN; NUCLEOPROTEIN; VIRUS RNA;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; EBOLAVIRUS; FEMALE; GLYCOPROTEINS; HEMORRHAGIC FEVER, EBOLA; HUMANS; INFANT; MALE; MIDDLE AGED; NUCLEOPROTEINS; POINT-OF-CARE SYSTEMS; REAL-TIME POLYMERASE CHAIN REACTION; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; RNA, VIRAL; SENSITIVITY AND SPECIFICITY; SIERRA LEONE; YOUNG ADULT;

EID: 84962120881     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001980     Document Type: Article

References (17)

1. Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, et al. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010;363:1005–1015. doi: 10.1056/NEJMoa090784720825313
2. Pinsky BA, Sahoo MK, Sandlund J, Kleman M, Kulkarni M, Grufman P, et al. Analytical performance characteristics of the Cepheid GeneXpert Ebola assay for the detection of Ebola virus. PLoS ONE. 2015;10:e0142216. doi: 10.1371/journal.pone.014221626562786
3. Trombley AR, Wachter L, Garrison J, Buckley-Beason VA, Jahrling J, Hensley LE, et al. Comprehensive panel of real-time TaqMan polymerase chain reaction assays for detection and absolute quantification of filoviruses, arenaviruses, and New World hantaviruses. Am J Trop Med Hyg. 2010;82:954–960. doi: 10.4269/ajtmh.2010.09-063620439981
4. Broadhurst MJ, Kelly JD, Miller A, Semper A, Bailey D, Groppelli E, et al. ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study. Lancet. 2015;386:867–874. doi: 10.1016/S0140-6736(15)61042-X26119838
5. Bland JM, Altman DG, Measuring agreement in method comparison studies. Stat Methods Med Res. 1999;8:135–160. 10501650
6. Southern TR, Racsa LD, Albarino CG, Fey PD, Hinrichs SH, Murphy CN, et al. Comparison of FilmArray(R) and qRT-PCR for the detection of Zaire Ebolavirus from contrived and clinical specimens. J Clin Microbiol. 2015;53:2956–2960. 26157148
7. Schieffelin JS, Shaffer JG, Goba A, Gbakie M, Gire SK, Colubri A, et al. Clinical illness and outcomes in patients with Ebola in Sierra Leone. N Engl J Med. 2014;371:2092–2100. doi: 10.1056/NEJMoa141168025353969
8. Strecker T, Palyi B, Ellerbrok H, Jonckheere S, de Clerck H, Bore JA, et al. Field evaluation of capillary blood samples as a collection specimen for the rapid diagnosis of Ebola virus infection during an outbreak emergency. Clin Infect Dis. 2015;61:669–675. doi: 10.1093/cid/civ39725991465
9. Walker NF, Brown CS, Youkee D, Baker P, Williams N, Kalawa A, et al. Evaluation of a point-of-care blood test for identification of Ebola virus disease at Ebola holding units, Western Area, Sierra Leone, January to February 2015. Euro Surveill. 2015;20(12). 25846490
10. Chua AC, Cunningham J, Moussy F, Perkins MD, Formenty P, The case for improved diagnostic tools to control Ebola virus disease in West Africa and how to get there. PLoS Negl Trop Dis. 2015;9:e0003734. doi: 10.1371/journal.pntd.000373426068890
11. Butler D, Ebola experts seek to expand testing. Nature. 2014;516:154–155. doi: 10.1038/516154a25503213
12. World Health Organization. Target product profile for Zaire ebolavirus rapid, simple test to be used in the control of the Ebola outbreak in West Africa. 2014 Oct 3 [cited 10 Mar 2015]. Available: http://www.finddiagnostics.org/programs/ebola/product_development/tpp.html.
13. US Food and Drug Administration. Emergency use authorization. [cited 23 Nov 2015]. Available: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm182568.htm.
14. World Health Organization. Emergency use assessment and listing (EUAL) procedure for Ebola virus disease (IVDs). [cited 23 Nov 2015]. Available: http://www.who.int/diagnostics_laboratory/procurement/purchasing/en/.
15. Broadhurst MJ, Semper A, Bailey D, Pollock NR, ReEBOV Antigen Rapid Test kit for Ebola—authors’ reply. Lancet. 2015;386:2255–2256. 26681290
16. Leski TA, Ansumana R, Taitt CR, Lamin JM, Bangura U, Lahai J, et al. Use of the FilmArray System for detection of Zaire ebolavirus in a small hospital in Bo, Sierra Leone. J Clin Microbiol. 2015;53:2368–2370. doi: 10.1128/JCM.00527-1525972415
17. Weller SA, Bailey D, Matthews S, Lumley S, Sweed A, Ready D, et al. Evaluation of the Biofire FilmArray BioThreat-E Test (v2.5) for rapid identification of ebola virus disease in heat-treated blood samples obtained in Sierra Leone and the United Kingdom. J. Clin Microbiol. 2016;54:114–119. doi: 10.1128/JCM.02287-1526537445