Periodic Reporting for period 1 - Mofina (Mobile Filovirus Nucleic Acid Test – Sofia ref.: 115848)
Okres sprawozdawczy: 2015-02-01 do 2017-04-30
We have successfully developed an automated molecular point-of-care (POC) system for the safe, rapid, specific, and sensitive detection of infection with different species/strains of Ebola, and the related virus, Marburg, directly from 'finger-prick' capillary (or venous) blood samples.
The system combines Altona´s Pan-filo screening IVD test with the existing Alere(tm) q point-of-care molecular diagnostics platform.
The purpose of this project was to utilize existing and proven CE IVD marked real-time PCR based assay(s) designed for laboratory use and to take advantage of the Alere(tm) q point-of-care molecular instrument and cartridge design to simplify Ebola testing.
The goal is to expand molecular testing to sites where high-end laboratory infrastructure is not available, while simultaneously greatly reducing infection risk and improving safety for the test operator.
The project aimed for the fast development of a point-of-care Nucleic Acid Test (POC-NAT) system for the detection of filovirus-specific RNA, from human sample material, especially from blood samples.
The system combines Altona´s Pan-filo screening IVD test with the existing Alere(tm) q point-of-care molecular diagnostics platform.
The purpose of this project was to utilize existing and proven CE IVD marked real-time PCR based assay(s) designed for laboratory use and to take advantage of the Alere(tm) q point-of-care molecular instrument and cartridge design to simplify Ebola testing.
The goal is to expand molecular testing to sites where high-end laboratory infrastructure is not available, while simultaneously greatly reducing infection risk and improving safety for the test operator.
The project aimed for the fast development of a point-of-care Nucleic Acid Test (POC-NAT) system for the detection of filovirus-specific RNA, from human sample material, especially from blood samples.
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.
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.
In comparison to "state of the art" technologies for Ebola diagnosis, including conventional RT-qPCR assays or POC systems, the MOFINA Project outcome provides a fully automated solution for detection of all known Ebola virus and Marburg virus strains with molecular limits of detection.
The new AlereTM q point-of-care cartridge is a fully integrated nucleic acid testing platform which delivers results in just over one hour, with sensitivities and specificities at accuracy levels seen in sophisticated laboratories.
Through its compact and portable design, together with an internal battery to bridge power outages and an external battery pack option (AlereTM Power Drum), the Filovirus detect cartridge relocates testing to the point of need - where we envisage it being used by contact tracing and alert teams in rural locations during an outbreak investigation.
Besides these key advantages, the system provides a holistic test panel, detecting different filovirus species (Zaire strain ebolavirus, Sudan strain ebolavirus, Bundibugyo strain ebolavirus, Reston strain ebolavirus, Taï Forest strain ebolavirus and Marburg virus) at the same time, giving the availability of a fast, reliable, and easy-to-use detection system for surveillance and monitoring.
This enables healthcare teams to perform rapid detection in remote areas of an Ebola-epidemic country, which helps to reveal new outbreak situations earlier, reduces contact with infected cases, and therefore limits opportunities for transmission during early outbreak response.
Outbreaks can be contained more quickly, and therefore reduce the number of those infected and decrease the cost burden.
For the long term, the platform can be exploited to an even broader pathogen panel within a diagnostic preparedness concept, as intended by the existing collaboration.
Following a request from WHO, the partners aim to develop and manufacture diagnostic assay panels covering each of the WHO priority pathogens by a combined POC and central lab approach.
This approach addresses the critical needs within an arising outbreak situation and will allow detection across a broad range, comparing diagnostic data on all levels, and in consequence lead to more effective surveillance.
The new AlereTM q point-of-care cartridge is a fully integrated nucleic acid testing platform which delivers results in just over one hour, with sensitivities and specificities at accuracy levels seen in sophisticated laboratories.
Through its compact and portable design, together with an internal battery to bridge power outages and an external battery pack option (AlereTM Power Drum), the Filovirus detect cartridge relocates testing to the point of need - where we envisage it being used by contact tracing and alert teams in rural locations during an outbreak investigation.
Besides these key advantages, the system provides a holistic test panel, detecting different filovirus species (Zaire strain ebolavirus, Sudan strain ebolavirus, Bundibugyo strain ebolavirus, Reston strain ebolavirus, Taï Forest strain ebolavirus and Marburg virus) at the same time, giving the availability of a fast, reliable, and easy-to-use detection system for surveillance and monitoring.
This enables healthcare teams to perform rapid detection in remote areas of an Ebola-epidemic country, which helps to reveal new outbreak situations earlier, reduces contact with infected cases, and therefore limits opportunities for transmission during early outbreak response.
Outbreaks can be contained more quickly, and therefore reduce the number of those infected and decrease the cost burden.
For the long term, the platform can be exploited to an even broader pathogen panel within a diagnostic preparedness concept, as intended by the existing collaboration.
Following a request from WHO, the partners aim to develop and manufacture diagnostic assay panels covering each of the WHO priority pathogens by a combined POC and central lab approach.
This approach addresses the critical needs within an arising outbreak situation and will allow detection across a broad range, comparing diagnostic data on all levels, and in consequence lead to more effective surveillance.