Table 1

Six of the 10 WHO Blueprint priority diseases have significant diagnostic gaps

WHO Blueprint priority disease4 Fatality rateRecent outbreaksDiagnostic need
(red: critical, yellow: important; green: unaddressed)*5
Situation overview5
CCHF10%–40%38 Pakistan, 2010.39
  • No established reference test.

  • Very limited availability of commercial assays, with very low usage and limited performance data.

  • No WHO prequalified diagnostic test.

Filoviruses (Ebola and Marburg)24%–90%40 41 West Africa,
2013–2016 and DRC 2017 and 2018 (Ebola).10
Uganda and Kenya, 2017 (Marburg).42
  • Recent high-profile outbreaks resulted in international focus and funding, which has enabled the development and introduction of critical diagnostics.

  • Additional work is needed to improve current diagnostics, develop POC tests and ensure reliable availability.

  • Additional work is also needed to ensure regulatory approval beyond WHO EUAL.

Lassa fever1–15%43 Annual recurring outbreaks in West Africa.44
  • No WHO-approved diagnostics and limited commercially available tests, none of which are easily deployable in the settings needed.

MERS-CoV~35%45 Saudi Arabia, 2013–2018.
South Korea, 2015.46
  • Limited availability of validated assays, restricted to highly complex tests.

  • Lack of POC diagnostics.

SARS~10%47 Global, 2003.47
  • Recent high-profile outbreaks resulted in international focus and funding, which has enabled the development and introduction of critical diagnostics.

  • Additional work is needed to improve current diagnostics, develop POC tests and ensure reliable availability.

Nipah and henipaviral diseases~30%48 Bangladesh, 2004.49
India, 2018.50
  • No WHO-approved diagnostics and limited commercially available tests, none of which are easily deployable in the settings needed.

Rift Valley fever<1%51 Republic of Niger, 2016.51
  • No WHO-approved diagnostics and limited commercially available tests, none of which are easily deployable in the settings needed.

Zika virus diseaseNot fatal52 South and North America, 2015–2016.29
  • Recent high-profile outbreaks resulted in international focus and funding, which has enabled the development and introduction of critical diagnostics.

  • Additional work is needed to improve current diagnostics, develop POC tests and ensure reliable availability.

  • Additional work is needed to ensure regulatory approval beyond WHO EUAL.

Disease X
  • Need for diagnostic platforms that can rapidly adapt and support diagnostics for unknown pathogens.

  • *Red/critical: diagnostics needed but not currently available or validated; yellow/important: diagnostics currently under development; green/unaddressed: diagnostics available but may need improvement.

  • CCHF, Crimean-Congo haemorrhagic fever; EUAL, Emergency Use Assessment and Listing; MERS-CoV, Middle East respiratory syndrome coronavirus; POC, point of care; SARS, severe acute respiratory syndrome.