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:

2. Hepatitis B TPP:

3. Malaria TPP:

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: