Rezultaty
The IRISCOV website will be set up hosted and maintained by a professional Care will be taken to specifically address all related research clinical disciplines and use cases The use of interactive features on the website eg comments personal experiences feedback will be examined and used as appropriate for the different target groups The website will also feature a consortiuminternal section with collaboration tools for data exchange and management including a secure data exchange platform timeline online Gantt chart calendar mailing and address lists and dissemination support visual identity guidelines logos funding acknowledgements open access guidelines poster kit introductory slide deck and document templates
Brochure conceived as a dissemination toolA brochure introducing the project will be prepared in the beginning of the project To guarantee high visibility and recognisability a charter will define the IRISCOV visual identity including logo colours fonts and templates
Video conceived as a dissemination toolAn attractive introductory video will be prepared at the project start It will be conceived as a dissemination tool to interest researchers stakeholders and the public in the project also addressing an audience which cannot easily be reached by other means The video will be made available on the IRISCOV website and on online video sharing platforms to increase its visibility and facilitate dissemination
Alternative routes for qcLAMP SARSCoV2 detection without RNA extraction
Report on regulatory guidelines for testing by non-experts/home-testingMethods regarding the collection of nasopharyngeal swab or saliva samples suitable for hometesting
Report on data transmission and storage processAll anonymized data collected by the smartphone operating the device will be transmitted and stored to a central secure server at UCLH Data collected from all sites will be analyzed by UCLH expert team utilizing available tools dashboards to produce a large number of statistically significant results this will provide an additional data to support a strong case for certification towards the release of IRIS for COVID19 detection
Protect IP in the regions of interest by regional patent registration in Europe, North America & South Africa at M18Continue the protection of IP in the regions of interest by regional patent registration in Europe North America South Africa up to M18 Specifically further patents are expected to be filed in order to secure the freedom to operate going In accordance with the exploitation guidelines of the EU Model Grant Agreement it is intended that all related IP of this work will be conditionally licensed to third parties in order to maximise production capacity and help manage the public health emergency due to SARSCoV2
Report on all scientific outputsAll partners engaged in research will endeavour to publish project results in nternationally recognised scientific outlets and make presentations at conferences The list will be continuously updated and will highlight the target audience and the expected dissemination impact for the project
Products classification report and conformity assessment routeThe products will be classified based on the guidance document MEDDEV 216 2012 and the IVDR accordingly and their conformity assessment route will be decided respectively M2
Performance Evaluation and Clinical Performance report at M18This report will be the second official Performance Evaluation and Clinical Performance report of the two products based on the methodology provided to the 136122002 for the IVD and the ISO 209162019 respectively More particularly these reports will verifyvalidate the Performance and Clinical Performance Methodology of the Clinical studies that the current project has followed the proper Regulatory roadmap for the validation accuracy and efficacy of the four products Furthermore this report will provide all the analysis of Data clinical documentation that will be collected during the validation studies summarized in one Report The updated report should be performed based on the design changes for the industrial manufacturing scaling up and should accompany the submission of the Technical Documentation of the four devices to the selected Notified Body
Deliver at least 1000 devices in Europe, 1000 Devices in the USA and 500 devices in sub-Saharan AfricaDistribution of device and consumables to existing commercial partners
Risk management report at M5This report will be a first stage report verifying the methodology of the EN ISO149712012 and that the design and development of the four products until the TRL 8 does not conclude to unacceptable risks
Usability report at M5This report will integrate all the User Interface Specifications by design as well as will act as a validation report to ensure the applicability and the validity of the design of the IVD medical devices as per EN 623662008 requirements
Retire from circulation 30% of the first-generation devices and replace them with IVDR/CE certified deviceThe 3D printed device will have an expected life cycle of 12months and its injectionmolded replacement model which will be released in month 18 will have an expected device life cycle of 3 years As the production cost of the devices is very low 100 it is foreseen that the initial buyers of the former device will have the opportunity to exchange their retired device with a new one for an incremental cost at M18
Clinical evaluation report on the performance of the IRIS device and accompanied SARS-CoV-2 and influenza tests directly in saliva or swabAll participating sites will perform an evaluation of the IRIS device in combination with the qcLAMP assay for the corona virus and influenza to be developed in WP4 Tasks 41 ie working directly from crude samples
Performance Evaluation and Clinical Performance report at M5This report will be the first official Performance Evaluation and Clinical Performance report of the two products based on the methodology provided to the 136122002for the IVD and the ISO 209162019 respectively More particularly these reports will verifyvalidate the Performance and Clinical Performance Methodology of the Clinical studies that this project will follow for the validation accuracy and efficacy of the four products Furthermore this report will provide all the analysis of Data clinical documentation that will be collected during the validation studies summarized in one Report
Report on clinical performance of the SARS-CoV-2 and influenza qcLAMP assays based on the IRIS device400 patients samples will be used to evaluate the IRISbased detection assays already developed by FORTH partner using extracted RNA from patients samples 200 samples for COVID and 200 for flu using in each case 100 positive and 100 negative in order to perform a reliable statistical analysis that will be suitable for the certification process the above number of samples will be tested in each clinical site 800 samples in total
Report on SARS-CoV-2 and influenza detection assay directly from saliva samplesOptimized qcLAMP detection protocol directly from saliva samples from patients with COVID andor influenza
Protect IP in the regions of interest by regional patent registration in Europe, North America & South Africa at M5Further patents are expected to be filed in order to secure the freedom to operate going forward Moreover in accordance with the exploitation guidelines of the EU Model Grant Agreement it is intended that all related IP of this work will be conditionally licensedto third parties in order to maximise production capacity and help manage the public health emergency due to SARSCoV2
Usability report at M18This report will integrate all the User Interface Specifications by design per each product as well as will act as a validation report to ensure the applicability and the validity of the design of the four IVD medical devices as per EN 623662008 requirements The updated report should be performed based on the design changes for the industrial manufacturing scaling up and should accompany the submission of the relevant Technical Documentation of the fours products to the selected Notified Body
ISO 13485 & compliance as per ISO 27001:2015 and GDPRBIOPIXT will be certified as a medical device design testing and manufacturing company as per ISO 134852016 with intended full compliance on Data Safety and Security as perISO 270012015 and GDPR
Risk management report at M18This report will be an updated report D12 verifying the methodology of the EN ISO 149712012 along with design and development of the four products which does not direct to any unacceptable risks up to the TRL8 The updated report should be performed based on the design changes for the industrial manufacturing scaling up and should accompany the submission of the relevant Technical Documentation regarding the four products to the Notified Body
Report on full dissemination planIRISCOV is designed to be in permanent contact and exchange with the different target groups including the clinical community health care professionals nongovernment organisations and the public at large community groups but also business sectors active in health care
The respective kit will be provided in two package sizes 100 and 500 reactions each The components of each package are 1 enzymereaction mix 2 primer mix identifying SARSCoV2 specific sequence 3 primer mix identifying a human gene internal specimen control 4 synthetic SARS CoV 2 template reaction control 5 RNase free water
Publikacje
Autorzy:
G. Papadakis, A.K. Pantazis, N. Fikas, S. Chatziioannidou, V. Tsiakalou, V. Pogka, M. Megariti, J. Heaney, E. Nastouli, T. Karamitros, A. Mentis, A. Zafiropoulos, G. Sourvinos, S. Agelaki, E. Gizeli
Opublikowane w:
Scientific Reports, Numer 12, 2022, Strona(/y) Article Number: 3775, ISSN 2045-2322
Wydawca:
Nature Publishing Group
DOI:
10.1038/s41598-022-06632-7
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