Steward health care norwood hospital1/13/2024 Results are available around an hour after a crude sample is added to the pouch. The FilmArray was developed to provide low-operative-burden, point-of-care (PoC), diagnostic screening capability within a health care setting. The FilmArray PCR platform (Biofire Diagnostics, UT) integrates sample processing, nucleic acid extraction and purification, and a multiple PCR analysis in a single-use, disposable pouch ( 5). As such, stringent laboratory infrastructure and containment procedures are required to handle viable EBOV material, and only a few laboratories in Europe and elsewhere are equipped to do so ( 3), though United Kingdom guidelines do allow primary clinical analyses of samples from individuals with possible EBOV infection to be carried out under less-stringent containment conditions ( 4). EBOV is designated in the United Kingdom by the Advisory Committee on Dangerous Pathogens (ACDP) a hazard group 4 (HG4) pathogen that must be handled under containment level 4 (CL-4) conditions (biosafety level 4 in other countries). The preferred sample for detecting EBOV, an enveloped negative-sense single-stranded RNA virus, is EDTA with blood, serum, or plasma, with the primary diagnostic technology being real-time PCR ( 2). These samples have been taken primarily from United Kingdom citizens with a history of recent travel to West Africa, and the vast majority of the samples have not been infected with EBOV. Since the outbreak began, the designated United Kingdom EBOV testing laboratory, the Rare and Imported Pathogens Laboratory, Public Health England (PHE), has been testing 10 to 15 samples per week for EBOV, an approximate 10-fold increase over the normal testing frequency. 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.Īn Ebola virus (EBOV) outbreak has been ongoing in West Africa since December 2013 and was declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO) in August 2014 ( 1). 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. Statistical analysis (Fisher's exact test) indicated there was no significant difference between the methods at the 99% confidence level in either country. The BioThreat-E test had a sensitivity of 84% (confidence interval, 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. 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 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. Rapid Ebola virus (EBOV) detection is crucial for appropriate patient management and care.
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