Mobile Filovirus Nucleic Acid Test – Sofia ref.: 115848

ended

We are proposing to develop a molecular assay for the safe, rapid, specific and sensitive detection of Ebola Virus Infection in capillary (or venous) blood samples combining ALTONA’s Pan-filo screening IVD test with the existing Alere™ q point of care molecular diagnostics platform. The purpose of this project is to utilize existing and proven PCR assay(s) designed for laboratory use and to take advantage of the Alere™ q point of care molecular instrument and cartridge design to simplify Ebola testing so that molecular testing can be expanded to sites beyond which high end laboratory infrastructure is not available while simultaneously greatly reducing infection risk for the test operator. The project aims for the fast development of a point of care Nucleic Acid Test (POC-NAT) system for filovirus specific RNA, from human sample material, especially from blood samples. The POC-NAT system will have the following features: 1. Field proven stand alone, mobile and easy to use instrumentation 2. ready to use cartridge, safely disposable nucleic acid test format with integrated sample preparation 3. assay for specific detection of RNA of all known species from the virus genera Ebola- and Marburgvirus . 4. process duration from sampling to result less than 45 min 5. no additional equipment and no logistics and storage at -20°C needed The POC-NAT is based on two already existing technologies: The instrument platform “Alere™q complete” developed and manufactured by Alere , an instrument for POC diagnostics recently used p.e. for Alere´s HIV-1/2 Detect cartridges, and altona Diagnostics´ RealStar® Filovirus RT-PCR kit 1.0, a commercial central laboratory real-time PCR test. The project partner aim for having the integration of platform and assay as a prototypic system completed until end of March 2015. The verification and validation of the workflow starts April 2015 at altona Diagnostics, BNITM and INMI. The aim of this project phase is to finally CE IVD mark the test system