229. Clinical Performance of the FilmArray BioThreat-E test for diagnosing Ebola Virus Disease in “alternate” specimen types: urine and saliva
Session: Poster Abstract Session: Diagnostics: Virology
Thursday, October 8, 2015
Room: Poster Hall
  • Poster 229 ID Week Gay Andrieu.pdf (753.9 kB)
  • Background: The current Ebola outbreak has highlighted the need for efficient diagnostic tools. Diagnosis of Ebola Virus Disease (EVD) has relied on RT-PCR techniques on blood specimens. Non-invasive diagnosis would make the management of patients easier, faster, and safer for healthcare workers. The FilmArray (FA) system (BioFire Diagnostics, a bioMérieux company) is an automated and qualitative in vitro diagnostic platform that combines nucleic acid purification and nested multiplex RT-PCR. BioFire Defense has developed a commercially available FA test (BioThreat-E) designed to detect Ebola virus, Zaïre strain. In vitro technical performance obtained on spiked-whole blood and urine specimens has been shown (“ASM 2015” poster 1524) as well as clinical performance obtained from blood specimens in a clinical field trial in Guinea. We evaluated the use of the BioThreat-E test in urine and saliva specimens from patients in the same study.

    Methods: BioThreat-E test was evaluated on urine and saliva specimens, in comparison with routine blood testing [QuantiTect Probe RT-PCR® (Qiagen) confirmed by  RealStar® Filovirus Type RT-PCR Kit 1.0 (Altona)] in EVD-suspected cases in a diagnostic and treatment center in Guinea. Urine and saliva were requested for all patients enrolled in the study, but analysis was performed on EV positive patients only.

    Results: As of May 8, 2015 after 2 months of enrollment, 78 EVD-suspected patients were enrolled, with 35 positive by routine testing. Of the 35 positives, 18 patients gave a saliva sample and 7 gave a urine sample. In all 25 non-blood samples, the BioThreat-E test was positive, demonstrating 100% sensitivity for these 2 specimen types in this select patient population. The study is still ongoing.

    Conclusion: In field conditions in Guinea, the FA BioThreat-E test has a very high sensitivity for diagnosing EVD from urine and saliva. This test requires no sample prep, is easy to use, and gives results in about 1 hour. The BioThreat-E test, when performed on non-invasive samples like saliva and urine could be an immensely helpful tool for the individual diagnosis as well as surveillance of Ebola Virus in many different settings, including “in the field” in low-resource settings as well as in any category of laboratory.

    N'faly Magassouba, PhD1, Françoise Gay-Andrieu, MD, PhD2, Valentina Picot, VetD3, Christophe Peyrefitte, PharmD, PhD4, Brigitte Dacosta, MSc2, Frédéric Bedin, PhD2, Amadou Doré, Tech1, Fodé Kourouma, Tech1, Jean-Louis Machuron, PharmD3, Christophe Longuet, MD, MPH3, Cynthia Phillips, PhD5, Matt Scullion, PhD5 and Mark Miller, MD2, (1)Laboratoire National des Fièvres Hémorragiques en Guinée, Conakry, Guinea, (2)bioMérieux, Marcy l'Etoile, France, (3)Fondation Mérieux, Lyon, France, (4)Institut de Recherche Biomédicale des Armées, Brétigny sur Orge, France, (5)BioFire Defense, LLC, Salt Lake City, UT


    N. Magassouba, None

    F. Gay-Andrieu, bioMérieux: Employee , Salary

    V. Picot, None

    C. Peyrefitte, None

    B. Dacosta, bioMérieux: Employee , Salary

    F. Bedin, bioMerieux: Employee , Salary

    A. Doré, None

    F. Kourouma, None

    J. L. Machuron, None

    C. Longuet, None

    C. Phillips, BioFire Defense: Employee , Salary

    M. Scullion, BioFire Defense: Employee , Salary

    M. Miller, bioMerieux: Employee , Salary

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