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 United Kingdom (original) (raw)

Journal of Clinical Microbiology, 2015

Abstract

Rapid Ebola virus (EBOV) detection is crucial for appropriate patient management and care. The performance of the FilmArray Biothreat E-test (v2.5), against whole blood samples, was evaluated in Sierra Leone and the United Kingdom (UK), and compared with results generated by a real-time Ebola Zaire PCR reference method. In diagnostic laboratories samples were tested on availability, included successive samples from individual patients, and were heat treated to facilitate EBOV inactivation prior to PCR. In Sierra Leone (n=60; 44 patients), the Biothreat E-test had a sensitivity of 84% (confidence interval, CI: 64-95%) and specificity of 89% (CI: 73-97%); and in the UK (n=108; 70 patients), a sensitivity of 75%, (CI: 19-99%) and specificity of 100% (CI: 97-100%), when compared to the reference real-time PCR. Statistical analysis (Fisher's Exact test) indicated there was no significant difference between methods at the 99% confidence level in either country. In 9 discrepant results (5 real-time PCR positives and E-test negatives; 4 real-time PCR negatives and E-test positives), the majority (8) were obtained from samples with an observed, or probable, low viral load. The FilmArray 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.

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