Evaluation of the FilmArray BioThreat-E Test

January 14, 2016 updated by: BioMérieux

Clinical Evaluation of the BioFire FilmArray® BioThreat-E Test for the Diagnosis of Ebola Virus Disease in West Africa

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Through study completion, an average of 6 months.
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.
Through study completion, an average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioMérieux

Collaborators

Fondation Mérieux
Donka University Hospital, Conakry

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EbolaFire

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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