Date: 2015-02-10
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Biocartis (Switzerland) Janssen Diagnostics, a J&J company (USA - NJ) the Institute for Tropical Medicine (Belgium)
Product: Rapid Ebola Virus Triage Test
Action mechanism:
Disease: Ebola fever
Therapeutic area: Diagnostic - Infectious diseases
Country:
Trial details:
Latest
news: * On February 10, 2015, Biocartis announces that it is in the testing phase of a Rapid Ebola Virus Triage Test that it is developing in association with Janssen Diagnostics and the Institute for Tropical Medicine in Antwerp (Belgium) for its Idylla™ system, a fully automated molecular diagnostic platform that is CE-IVD marked in Europe. The Rapid Ebola Virus Triage Test is designed to enable healthcare workers, even in challenging environments, to test blood samples and aims at providing accurate and fast diagnosis of Ebola. The test is designed to offer a unique combination of speed, sensitivity, accuracy and ease-of-use required for outbreaks where time is of the essence. The test uses 0,2 ml blood that is added directly to the Idylla™ cartridge, which contains all necessary reagents on board for performing the analysis on Biocartis’ fully automated, molecular diagnostics system. A complete analysis of the sample takes around 90 minutes and can be operated by healthcare professional in most settings, including in the field, making the test ideal for use in regions with limited infrastructure. After testing of synthetic virus samples in Belgium and the US, Biocartis has now registered for field-testing in West Africa to gather additional clinical evidence for the test performance.
