Comparison of FilmArray and Quantitative Real-Time Reverse Transcriptase PCR for Detection of Zaire Ebolavirus from Contrived and Clinical Specimens

• Type of Material: Article
• Authors: Timothy R. Southern, University of Nebraska Medical Center; Lori D. Racsa, Emory University; César G. Albariño, Centers for Disease Control and Prevention; Paul D. Fey, University of Nebraska Medical Center; Steven H. Hinrichs, University of Nebraska Medical Center; Caitlin N. Murphy, University of Nebraska Medical Center; Vicki L. Herrera, Nebraska Public Health Laboratory; Anthony R. Sambol, Nebraska Public Health Laboratory; Charles Hill, Emory University; Emily L. Ryan, Emory University; Colleen Kraft, Emory University; Shelley Campbell, Centers for Disease Control and Prevention; Tara K. Sealy, Centers for Disease Control and Prevention; Amy Schuh, Centers for Disease Control and Prevention; James Ritchie, Emory University; George Lyon III, Emory University; Aneesh Mehta, Emory University; Jay Varkey, Emory University; Bruce Ribner, Emory University; Kent P. Brantly, Samaritan's Purse; Ute Ströher, Centers for Disease Control and Prevention; Peter C. Iwen, University of Nebraska Medical Center; Eileen Burd, Emory University
• Language: English
• Date: 2015-09-01
• Publisher: American Society for Microbiology
• Publication Version: Final Published Version
• Copyright Statement: © 2015 American Society for Microbiology. All Rights Reserved.
• Final Published Version (URL): http://dx.doi.org/10.1128/JCM.01317-15
• Title of Journal or Parent Work: Journal of Clinical Microbiology
• ISSN: 0095-1137
• Volume: 53
• Issue: 9
• Start Page: 2956
• End Page: 2960
• Keywords: Microbiology; VIRUS DISEASE; UNITED-STATES; Science & Technology; Life Sciences & Biomedicine
• Research Categories: Biology, Microbiology; Biology, Virology; Health Sciences, Pathology

Abstract

Rapid, reliable, and easy-to-use diagnostic assays for detection of Zaire ebolavirus (ZEBOV) are urgently needed. The goal of this study was to examine the agreement among emergency use authorization (EUA) tests for the detection of ZEBOV nucleic acids, including the BioFire FilmArray BioThreat (BT) panel, the FilmArray BT-E panel, and the NP2 and VP40 quantitative real-time reverse transcriptase (qRT) PCR assays from the Centers for Disease Control and Prevention (CDC). Specimens used in this study included whole blood spiked with inactivated ZEBOV at known titers and whole-blood, plasma, and urine clinical specimens collected from persons diagnosed with Ebola virus disease (EVD). The agreement for FilmArray and qRT-PCR results using contrived whole-blood specimens was 100% (6/6 specimens) for each ZEBOV dilution from 4×10⁷ to 4×10² 50% tissue culture infective dose (TCID50)/ml, as well as the no-virus negative-control sample. The limit of detection for FilmArray and qRT-PCR assays with inactivated ZEBOV, based on duplicate positive results, was determined to be 4×10² TCID50/ml. Rates of agreement between FilmArray and qRT-PCR results for clinical specimens from patients with EVD were 85% (23/27 specimens) for whole-blood specimens, 90% (18/20 specimens) for whole-blood specimens tested by FilmArray testing and matched plasma specimens tested by qRT-PCR testing, and 85% (11/13 specimens) for urine specimens. Among 60 specimens, eight discordant results were noted, with ZEBOV nucleic acids being detected only by FilmArray testing in four specimens and only by qRT-PCR testing in the remaining four specimens. These findings demonstrate that the rapid and easy-to-use FilmArray panels are effective tests for evaluating patients with EVD.