In addition to an extensive project management work package (Work Package 0), this action was separated into six distinct, largely sequential work packages.
Work Package 1 involved the design of platform-specific PCR probes for target capture, design of DNA array-specific amplification probes, and the technology transfer of Altona's RealStar(r) assay primer sequences to the Alere(tm) q platform. his work was successfully completed early in the action, following productive collaboration between the two commercial partners.
In Work Package 2, Alere developed a prototype pan-filovirus cartridge for the Alere(tm) q platform based on the above technology and reagent transfer.
Leveraging the existing Alere(tm) q cartridge allowed Altona's previously manual PCR assays to be packaged into the Alere(tm) q automated format for further testing.
Work Package 3 involved the three public health institute partners - BNITM, PHE, and INMI - as well as FIND, working with Alere to conduct system verification by testing a fully functional prototype system with viral reagents (contrived samples consisting of viral nucleic acid or whole, live virus in human blood) from each partners' own collection of reference filovirus strains.
During this Work Package, Alere conducted design transfer from development into operations, including manufacturing process validation, complete documentation, development and transfer of quality control (QC) methods and acceptance criteria, and in-house analytical verification studies.
Following the studies described above, preparation of complete technical documentation for the final product version of the system and submission to the notified body was completed during Work Package 4.
This has led to a fully CE-IVD marked platform for the detection of filovirus strains - soon to be formally released.
In parallel to the above development, validation and verification (V&V), and documentation activities, clinical validation studies were conducted by FIND through Work Package 5.
The final product prototype systems were tested in a 'field' environment in Sierra Leone by using clinical samples from the West Africa 2014/15 Ebola outbreak; subsequently, the final CE-IVD product was tested clinically using banked samples collected in Guinea during the West Africa 2014/15 outbreak, and evaluated for ease of use.
Work Package 6: To support the above work, Alere has also developed various training materials and product inserts to allow full training of end-users, both as part of this action, and after commercial product release.
