1 Project Management and Coordination
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 |
2 NAT Preparation for Ghana Deployment
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 |
3 Local Manufacturing of Biologicals
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 |
4 Testing Strategy
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 |
5 Proof of Concept Serological Test Development Using Single-Chain Antibody Fragments (scFvs)
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 |
6 Clinical Study of NAT in COVID-19
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 |
7 Route to Market
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 |
8 Training and Capacity Building
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 |
9 Dissemination and Communication
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 |
