Accessible quality-assured diagnostics: Business Plan 2008-2013
Summary
Diagnostics are a critical component of efforts to reduce disease burden and help countries realize their health-related Millennium Development Goals and their use and need is increasingly promoted in WHO policies and strategies. Unfortunately, although many high quality diagnostic tests for infectious diseases are available, they are neither affordable nor accessible to patients in developing countries. For example, 500,000 babies die in sub- Saharan Africa every year from congenital syphilis because women lack access to a screening test for syphilis in pregnancy, and only 16% of TB cases are reported with a laboratory-confirmed diagnosis. The few existing tests that may be appropriate for use in primary health care settings in developing countries are sold and used with little evidence on their effectiveness because diagnostics are not subject to strict regulatory approval standards. There is an urgent need for accessible quality-assured diagnostics for infectious diseases of poverty, and for research to gather objective evidence on the cost-effectiveness of these tests in real-life settings.