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J Infect Dis. 2016 Oct 15;214(suppl 3):S203-S209. Epub 2016 Aug 11.

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

Author information

1
Corgenix, Broomfield, Colorado Department of Microbiology and Immunology.
2
Galveston National Laboratory, University of Texas Medical Branch.
3
Department of Microbiology and Immunology.
4
Lassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
5
Lassa Fever Program, Kenema Government Hospital Eastern Polytechnic Institute, Kenema Ministry of Health and Sanitation, Freetown, Sierra Leone.
6
Autoimmune Technologies.
7
Corgenix, Broomfield, Colorado.
8
Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.
9
Department of Pediatrics, Section of Infectious Diseases, Tulane University.
10
Ministry of Health and Sanitation, Freetown, Sierra Leone.
11
Lassa Fever Program, Kenema Government Hospital.
12
Zalgen Labs, Germantown, Maryland.
13
Department of Microbiology and Immunology Zalgen Labs, Germantown, Maryland.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

KEYWORDS:

Ebola; clinical; lateral flow immunoassay; point of care; validation

PMID:
27521365
PMCID:
PMC5050478
DOI:
10.1093/infdis/jiw261
[Indexed for MEDLINE]
Free PMC Article

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