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List of Deliverables By Work Package

No. Deliverable Name Lead Type Level
1.1 Project handbook and communications/documentation tools for file-sharing and discussion. UCAM R CO
1.2 List of initial Advisory Board members on website UCAM R PU
1.3 Midterm Report UCAM R PU
1.4 Inaugural Advisory Board meeting [cancelled] UCAM Other PU
1.5 EDPTC progress reports and financial reports UCAM R CI
2.0 Preparation for import of materials to Ghana. Submission to FDA (and export from EU) KCCR OTHER CO
2.1 Define end-user needs including the number of NAT systems and chips require for clinical testing KCCR R CO
2.2 PATHPOD systems and chips delivered for clinical testing in Ghana DTU DEM CO
2.3 Remote training course for use of PATHPOD system and chips DTU R CO
2.4 Workflow for PATHPOD use in Ghana to detect COVID19 DTU DEM CO
3.1 Engineered Boon2-BST and accompanying expression (inc autoinduction) and purification SOP UCAM DEM PU
3.2 Engineered Boon2-RT and accompanying expression and purification SOP. UCAM DEM PU
3.3 Application of Boon-enzymes in RT-LAMP protocol to detect SARS-Cov-2 KNUST DEM PU
3.4 Demonstrate the BOON-RT and BST Production at 1-2 L UCAM DEM CO
3.5 Engineered Boon2-scFV and accompanying expression and purification SOP. UCAM DEM PU
4.1 Description of model for pooled samples at low, medium and high prevalences of COVID-19 DTU R PU
4.2 Dataset for limit of detection and report on recommendations for clinical study design KNUST R CO
5.1 Modified and characterised high-affinity scFv UCAM DEM PU
5.2 Purified covid coat protein fragments UCAM DEM PU
5.3 AfriMx protocol and SOP UCAM R PU
5.4 Testing pre-screened clinical serum samples with AfriMx KNUST DEM PU
6.1 Study protocol and supporting documents completed KNUST R PU
6.2 Confirmation of study set up, recruitment and training of staff KNUST R CO

Institutional and regulatory approvals obtained (KNUST, UCAM)

6.4 Provide data for mid term report KNUST R CO
6.5 Comparative sample testing completed KNUST R CO
6.6 Record of data collection and analysis KNUST R CO
6.7 Publication of study report KNUST R PU
7.1 Report and dataset on legal and regulatory landscape for PATHPOD and similar IVDs in Ghana TATAA R PU
7.2 Commercialization plan for the Ghanaian market TATAA R CO
7.3 Regulatory information compiled for IVD use in Ghana, in anticipation of future filing. TATAA R CO
8.1 AfriDx Manufacturing course handbook and SOPs  UCAM R PU
8.2 AfriDx and AfriMx user course handbook and SOPs NMIMR R PU
8.3 AfriDx-KIT DNA Collection, user course handbook and SOPs UCAM R PU
9.1 Visual identity pack and website UCAM DEC PU
9.2 Data Management Plan UCAM DEC PU
9.3 Publication of Plan for Exploitation and Dissemination of Results UCAM R PU
9.4 AfriDx Fact or Myth? Posts and explanatory short articles DTU DEC PU
9.5 Video interviews with partners and stakeholders UCAM DEC PU

AfriDx policy briefs in electronic and printable format

Regulating local manufacturing of IVDs in Ghana

The potential role of isothermal nucleic acid tests in addressing COVID-19 diagnostics challenges in Ghana