Annex A: Target Product Profile (TPP) on Specifications
for Unmet Needs in Dengue, Hepatitis B, Malaria,
and Tuberculosis

1. Dengue TPP:

• Lateral flow point-of-care (POC) detection of NS1 for early fever (1st 5 days onset)
• Lateral flow POC for IgG and IgM after 5 days of 1st onset PCR based test for dengue serotypes for surveillance
• Diagnostics for secondary infection to identify suitable vaccine
• Further TPP info: https://www.who.int/tdr/publications/documents/dengue-diagnosis.pdf

2. Hepatitis B TPP:

• Rapid test kits in detecting HBsAg, following WHO recommendation
• Systems needed to support hepatitis B testing and procedures to ensure the quality and performance of the hepatitis B test kits used
• Further TPP info: https://www.who.int/diagnostics_laboratory/evaluations/hepb/en/

3. Malaria TPP:

• A lateral flow assay for Plasmodium Knowlesi has been highlighted as an important additional strain, other than P. Falsiparum.
• Further TPP info: http://unitaid.org/assets/Malaria_Diagnostics_Landscape_Update_Fe_2015.pdf

4. Tuberculosis TPP:

• Rapid point-of-care non-sputum-based test capable of detecting all forms of TB by identifying characteristic biomarkers or biosignatures
• Rapid triage TB test which is point-of-care that should be a simple, low-cost test that can be used by first-contact health-care providers to identify those who need further testing
• Rapid test for drug susceptibility that can be used at the microscopy-centre level of the health-care system to select first-line regimen-based therapy (the rapid DST test).
• The following anti-TB agents should be included in resistance testing at the microscopy level (they are presented in order of decreasing priority):
  • rifampicin
  • fluoroquinolones (including moxifloxacin)
  • isoniazid and pyrazinamide
• Further TPP: https://www.who.int/tb/publications/tpp_report/en/