Work Packages Overview
Effective management of the project to deliver a successful trial SARS-CoV-2 diagnostics in Ghana.
Objectives:- Facilitate communication among the participants e.g. via all-hands meetings. This provides an important basis for regular and constructive dialogue and exchange within the consortium.
- Provide an overview of progress and plans: some of this will be put on the project website (See WP 9 - Communication Activities) to serve stakeholders and the wider public. More detailed technical and management information will be delivered in the form of reports to EDCTP, including final project documentation.
- To oversee and assist the project’s advancement: WP1 will ensure that the skills, capacities and efforts of all involved partners are integrated for the benefit of the project and oversee the in-time and regular achievement of deliverables and milestones.
- To oversee development of strategic planning and seek appropriate advice from external experts.
Lead Institution: University of Cambridge
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 1.1 | Project handbook and communications/documentation tools for file-sharing and discussion. | UCAM | R | CO | 2 |
| 1.2 | List of initial Advisory Board members on website | UCAM | R | PU | 7 |
| 1.3 | Midterm Report | UCAM | R | PU | 8 |
| 1.4 | Inaugural Advisory Board meeting [cancelled] | UCAM | Other | PU | 11 |
| 1.5 | EDPTC progress reports and financial reports | UCAM | R | CI | 15 |
To adapt the PATHPOD point of care diagnostic system for detection of COVID-19 (SARS-CoV-2 virus) in Ghana.
Objectives:- Fabrication and contribution of at least 5 PATHPOD systems and around 800 cartridges for clinical studies of the PATHPOD system at KCCR and NMIMR (WP6).
- Sampling kits for field use that inactivate the virus on site will be provided for testing.
- Adaptation of the description of sampling, testing and all parameters for the PATHPOD system for use in a new context.
- Organisation of training courses on how to use the PATHPOD system for partners andusers.
- Collaboration with WP5 on integration of locally manufactured enzymes for the PATHPOD system and chip.
Lead Institution: Danish Technical University
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 2.0 | Preparation for import of materials to Ghana. Submission to FDA (and export from EU) | KCCR | OTHER | CO | 0 |
| 2.1 | Define end-user needs including the number of NAT systems and chips require for clinical testing | KCCR | R | CO | 1 |
| 2.2 | PATHPOD systems and chips delivered for clinical testing in Ghana | DTU | DEM | CO | 3 |
| 2.3 | Remote training course for use of PATHPOD system and chips | DTU | R | CO | 5 |
| 2.4 | Workflow for PATHPOD use in Ghana to detect COVID19 | DTU | DEM | CO | 5 |
Enable partners in Ghana to locally produce MMLV, Bst for RT-LAMP and scFVs thus removing reliance on importation and reducing supply chain risk.
Objectives:- Demonstrate local production of MMLV, Bst for RT-LAMP and scFVs.
- Reduce the cost of pr oduction and scale-up through low-cost expression and purification methods improving affordability for the Ghanaian market to diagnostic kits and further scale up of testing.
- Build capacity for adaptation of diagnostic kits using locally produced enzymes and scFVs
Lead Institution: University of Cambridge
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 3.1 | Engineered Boon2-BST and accompanying expression (inc autoinduction) and purification SOP | UCAM | DEM | PU | 4 |
| 3.2 | Engineered Boon2-RT and accompanying expression and purification SOP. | UCAM | DEM | PU | 7 |
| 3.3 | Application of Boon-enzymes in RT-LAMP protocol to detect SARS-Cov-2 | KNUST | DEM | PU | 9 |
| 3.4 | Demonstrate the BOON-RT and BST Production at 1-2 L | UCAM | DEM | CO | 11 |
| 3.5 | Engineered Boon2-scFV and accompanying expression and purification SOP. | UCAM | DEM | PU | 14 |
To introduce pooled sample screening in order to reduce the number of NATs performed with the PATHPOD, thus reducing costs and time required.
Objectives:- To gather data on important parameter for pooled sampling including limit of detection.
- To provide evidence-based recommendations for protocols and clinical study design in WP6 in order that WP6 is able to provide valid and useful results on the effectiveness of pooled screening.
Lead Institution: Kwame Nkrumah University of Science and Technology
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 4.1 | Description of model for pooled samples at low, medium and high prevalences of COVID-19 | DTU | R | PU | 1 |
| 4.2 | Dataset for limit of detection and report on recommendations for clinical study design | KNUST | R | CO | 6 |
To provide ‘proof of concept’ evidence for the development of sensitive and specific serological tests for COVID-19 exposure, using a single-chain antibody fragment (scFv) approach.
Objectives:- To identify and purify isoform-specific and high-affinity scFvs against human IgM and IgG immunoglobulins.
- To progress to the point of establishing working immunoassay formats using COVID-19 coat protein fragments and isolated scFvs as capture and/or detection reagents in quantitative ELISA and qualitative lateral flow immunoassays, that can selectively detect serum IgM and IgG antibodies against COVID-19 antigens.
- To adapt standard laboratory protein purification methods to enable local production of scFvs and COVID-19 coat protein fragment reagents for local ‘point of use’ protocols.
Lead Institution: University of Cambridge
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 5.1 | Modified and characterised high-affinity scFv | UCAM | DEM | PU | 5 |
| 5.2 | Purified covid coat protein fragments | UCAM | DEM | PU | 6 |
| 5.3 | AfriMx protocol and SOP | UCAM | R | PU | 15 |
| 5.4 | Testing pre-screened clinical serum samples with AfriMx | KNUST | DEM | PU | 15 |
To show that a low cost nucleic acid test platform is able to replace the standard diagnostic (Rt-qPCR) for detection of SARS-CoV-2.
Objectives:- To evaluate a novel point-of-care diagnostic (PATHPOD) and compare it to the standard diagnostic (Rt-qPCR) for detection of SARS-CoV-2, the causative agent of COVID-19.
- To set up a framework to conduct a prospective observational cohort study of COVID-19 patients and their contacts.
Lead Institution: Kwame Nkrumah University of Science and Technology
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 6.1 | Study protocol and supporting documents completed | KNUST | R | PU | 2 |
| 6.2 | Confirmation of study set up, recruitment and training of staff | KNUST | R | CO | 2 |
| 6.3 |
Institutional and regulatory approvals obtained (KNUST, UCAM) |
KNUST | R | PU | 3 |
| 6.4 | Provide data for mid term report | KNUST | R | CO | 8 |
| 6.5 | Comparative sample testing completed | KNUST | R | CO | 10 |
| 6.6 | Record of data collection and analysis | KNUST | R | CO | 12 |
| 6.7 | Publication of study report | KNUST | R | PU | 15 |
To provide the information and partners needed to establish a sustainable route to market for PATHPOD and AfriDx in Ghana.
Objectives:- Develop strategy for dissemination and exploitation of results.
- Gather information on the regulatory landscape for general or Emergency Use Authorisation (EUA) from diagnostic regulatory bodies in Ghana and prepare information in anticipation of future filing.
- Ensure freedom to operate for the device and local manufacturing of reagents
- Identify and secure local partners for future production and distribution of tests in a commercially sustainable way.
Lead Institution: University of Cambridge
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 7.1 | Report and dataset on legal and regulatory landscape for PATHPOD and similar IVDs in Ghana | TATAA | R | PU | 6 |
| 7.2 | Commercialization plan for the Ghanaian market | TATAA | R | CO | 12 |
| 7.3 | Regulatory information compiled for IVD use in Ghana, in anticipation of future filing. | TATAA | R | CO | 15 |
Enable Ghanaian partners to independently deploy the PATHPOD assay system for national COVID-19 testing response and build capacity for future design and development of diagnostics for disease outbreaks.
Objectives:- To train researchers and health care workers to safely and effectively conduct PATHPOD po int of care assays for COVID-19 tests at KCCR and NMIMR.
- To expand the current daily test capacity of the NMIMR and KNUST, enabling them to better cope with COVID-19 testing requirements and build pandemic preparedness for future outbreaks.
- To build capacity for the biological tools and reagents used in AfriDx and AfriMx to be manufactured locally in Ghana.
- To enable local adaption of AfriDx to relevant future viral diseases.
- To strengthen local pathways for progression along the di agnostics value chain from trial to approval, manufacturing and distribution, building on results from WP7-Route to Market
Lead Institution: Noguchi Memorial Institute for Medical Research
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 8.1 | AfriDx Manufacturing course handbook and SOPs | UCAM | R | PU | 6 |
| 8.2 | AfriDx and AfriMx user course handbook and SOPs | NMIMR | R | PU | 12 |
| 8.3 | AfriDx-KIT DNA Collection, user course handbook and SOPs | UCAM | R | PU | 15 |
Manage and implement effective, strategic communication, dissemination and stakeholders’ engagement activities to increase awareness, acceptance and foster uptake of the project results in Europe and Ghana. An integrated impact-driven approach will be adopted through a multi-stakeholder and multi-channel strategy.
Objectives:- Develop a Communication and Dissemination (C&D) Plan to deliver the C&D strategy. This aims to guarantee public and professional coverage, enabling widespread awareness and uptake of results at Europe/Ghana level and internationally.
- Define a clear Project Identity, enabling establishment of specific communication channels and formats, targeted to stakeholders’ communities and the general public.
- Pave the way for exploitation of the project outcomes beyond its duration by consolidating the project visibility among stakeholders and end-users at EU, Ghana and international level.
- Measure the impacts of the C&D activities through the intelligent use of outreach data, quantitative performance indicators and key qualitative assessments.
Lead Institution: University of Cambridge
Deliverables:| No. | Deliverable Name | Lead | Type | Level | Month |
| 9.1 | Visual identity pack and website | UCAM | DEC | PU | 3 |
| 9.2 | Publication of Plan for Exploitation and Dissemination of Results | UCAM | R | PU | 4 |
| 9.3 | AfriDx Fact or Myth? Posts and explanatory short articles | DTU | DEC | PU | 4 |
| 9.4 | Video interviews with partners and stakeholders | UCAM | DEC | PU | 10 |
| 9.5 |
AfriDx policy briefs in electronic and printable format |
UCAM | DEC | PU | 15 |