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Rapid Ebola virus (EBOV) detection is crucial for appropriate patient management and care. The performance of the FilmArray BioThreat-E test (v2.5) using whole-blood samples was evaluated in Sierra Leone and the United Kingdom and was compared with results generated by a real-time Ebola Zaire PCR reference method. Samples were tested in diagnostic laboratories upon availability, included successive samples from individual patients, and were heat treated to facilitate EBOV inactivation prior to PCR. The BioThreat-E test had a sensitivity of 84% (confidence interval [CI], 64% to 95%) and a specificity of 89% (CI, 73% to 97%) in Sierra Leone (n = 60; 44 patients) and a sensitivity of 75% (CI, 19% to 99%) and a specificity of 100% (CI, 97% to 100%) in the United Kingdom (n = 108; 70 patients) compared to the reference real-time PCR. Statistical analysis (Fisher's exact test) indicated there was no significant difference between the methods at the 99% confidence level in either country. In 9 discrepant results (5 real-time PCR positives and BioThreat-E test negatives and 4 real-time PCR negatives and BioThreat-E test positives), the majority (n = 8) were obtained from samples with an observed or probable low viral load. The FilmArray BioThreat-E test (v2.5) therefore provides an attractive option for laboratories (either in austere field settings or in countries with an advanced technological infrastructure) which do not routinely offer an EBOV diagnostic capability.

Original publication

DOI

10.1128/jcm.02287-15

Type

Journal

Journal of clinical microbiology

Publication Date

01/2016

Volume

54

Pages

114 - 119

Addresses

Defence Science and Technology Laboratory, Ministry of Defence, Porton Down, Salisbury, United Kingdom sweller@dstl.gov.uk.

Keywords

Blood, Humans, Hemorrhagic Fever, Ebola, Specimen Handling, Molecular Diagnostic Techniques, Sensitivity and Specificity, Time Factors, Sierra Leone, Ebolavirus, Hot Temperature, United Kingdom