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Evaluation of the FilmArray BioThreat-E Test

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ClinicalTrials.gov Identifier: NCT02658331
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Collaborators:
Fondation Mérieux
Donka University Hospital, Conakry
Information provided by (Responsible Party):
BioMérieux

Brief Summary:
The aim of our study is to assess the analytical and clinical performance of the FilmArray (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in Guinea versus conventional molecular techniques.

Condition or disease
Ebola Virus Disease

Detailed Description:

The study will be conducted at the "Laboratoire des Fièvres Hémorragiques Virales" in Donka National Hospital (Conakry, Guinea), which is the Reference Laboratory for Hemorrhagic Fevers in Guinea. The reference based population includes the regions of Conakry and Coyah. No specific invasive intervention is required for this research protocol and the study does not interfere with the management of the patients according to the ongoing practices in Donka Ebola Treatment Center and in Coyah Ebola Treatment Center. Each participant will be verbally informed before signing an informed consent. Clinical data will be collected and recorded via a source document questionnaire - Clinical Report Form - based on the routine clinical data already provided to the laboratory according to the practices. Another questionnaire will be submitted to the biologist and technicians involved in the study to assess the practicability of the FilmArray technology, compared to conventional techniques, in terms of time to results, duration of test manipulation, sense of personnel safety for specimen handling, overall workload after each day, and preference of lab professionals.

As the main objective, analytical performance (sensitivity and specificity) and clinical performance (positive and negative predictive values) of the FA BioThreat-E test in whole blood will be evaluated in comparison with the QuantiTect® Probe RT-PCR (Qiagen) and the RealStar® Filovirus Type RT-PCR Kit 1.0 (Altona) both tests performed on serum.

The status for EVD will be defined for each patient based on the result of routine testing:

  • Positive patients: patients enrolled in the study showing positive results with the two routine PCR performed in the lab: QuantiTect Probe RT-PCR® and RealStar® Filovirus Type RT-PCR Kit 1.0.
  • Negative patients: patients enrolled in the study showing negative results with the two routine PCR performed in the lab: QuantiTect Probe RT-PCR® and RealStar® Filovirus Type RT-PCR Kit 1.0.
  • Equivocal patients: all other results showing a discrepancy between the two routine tests.

As a secondary objective, the possibility of using the FilmArray (FA) BioThreat-E test on non-invasive specimens will also be assessed. Urine and saliva specimens will be analyzed by FA for confirmed positive cases only (based on routine testing), for patients able to provide saliva and/or urine specimens according to their health condition.

This research protocol was approved by the Guinean Ethical Committee.

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Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of the BioFire FilmArray® BioThreat-E Test for the Diagnosis of Ebola Virus Disease in West Africa
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola




Primary Outcome Measures :
  1. Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test performed on whole blood. [ Time Frame: Through study completion, an average of 6 months. ]
    Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test in comparision with their Ebola Virus Disease status as defined based on the result of routine testing.


Secondary Outcome Measures :
  1. Number of urine specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a urine specimen. [ Time Frame: Through study completion, an average of 6 months. ]
  2. Number of saliva specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a saliva specimen. [ Time Frame: Through study completion, an average of 6 months. ]

Biospecimen Retention:   Samples With DNA
Whole blood Urine Saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of Ebola Virus Disease according to WHO criteria, and considered as eligible for Ebola routine diagnosis.
Criteria

Inclusion Criteria:

  • All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of EVD according to WHO criteria, and considered as eligible for Ebola routine diagnosis.
  • Ability to deliver a written informed consent

Exclusion Criteria:

  • Age below 18.
  • Inability to provide a consent
  • Inability to provide the blood specimens required for Ebola virus disease diagnosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658331


Sponsors and Collaborators
BioMérieux
Fondation Mérieux
Donka University Hospital, Conakry
Investigators
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Study Chair: Françoise Gay-Andrieu, MD-PhD BioMérieux
Principal Investigator: N'Fally Magassouba, PhD Laboratoire des Fièvres Hémorragiques en Guinée - Université Gamal Nasser, Conakry.
Study Director: Mark Miller, MD-FRCPC BioMérieux
Publications:
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Responsible Party: BioMérieux
ClinicalTrials.gov Identifier: NCT02658331    
Other Study ID Numbers: EbolaFire
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BioMérieux:
Ebola Virus Disease
Rapid Diagnosis
Point of care
Molecular platform
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections