In January 2001, a joint consultation by WHO/TDR and the Wellcome Trust was convened as a follow-up to the Wellcome Trust meeting in Durban, South Africa in 2000 on Sexually Transmitted Infections (STI) Diagnosis in the Developing World to develop a plan of action to address issues in the development of STI diagnostics appropriate for primary health care settings in the developing world.  The meeting objectives were:

• To review rapid STI diagnostic priorities

• To prepare for field trials of promising rapid STI diagnostics

• To identify biomedical and operational research needs for test development and deployment

The outcome of this meeting is summarised as follows: 

Priorities for rapid STI diagnostics

Disease	Indication	Ideal specimen
Chlamydia Gonorrhoea	Screening of high risk population Support of syndromic management in high and low disease prevalence settings	Woman: vaginal swab Man: urine

Preparation for FIELD TRIALS  

• Review available data for each candidate test to prioritize for initial trials and ongoing monitoring of new candidates and pre-clinical data 

• Share information on new diagnostics with interested parties through the SDI web site  

• Diagnostics evaluation to be conducted in a two-stage process: 1) laboratory-based evaluations performed by network of laboratory sites and reference laboratories and selection of promising candidates for field trials based on the results, 2) field evaluations in developing countries  

• Field trials of promising candidates to assess:  

1. Test performance characteristics
2. Patient and health care worker acceptability, affordability and sustainability in primary health care settings
3. Cost-effectiveness in field settings in populations of intended use
4. Impact on disease sequelae and transmission, including HIV transmission

• Dissemination of trial results

• Policy implications

Biomedical and operational needs

A research agenda to develop improved or new diagnostic tools should include:

• Identification of new diagnostic targets or markers for disease

• Quantification of pathogen heterogeneity by geography, setting and symptomatic status, definition of relationship between organism load and transmission/sequelae

• Sampling technologies/materials to allow the use of non-invasive specimens for testing

• Development of standardized reagents and a specimen bank

• Identification of new etiologic agents for STI syndromes

• Use of mathematical models to assess the cost-effectiveness and impact of new diagnostic tools

Guiding principles for SDI

• Use a two-pronged approach: continue to “prime the pump” with new diagnostic discoveries while beginning field trials of existing tests as soon as possible.

• Do not let “perfect” be the enemy of “good”: a rapid point-of-care test could have a major impact, even if its sensitivity is less than 80% of the gold standard.

• SDI should leverage the buying power of industrialised countries whenever possible to stimulate industry efforts in rapid STI diagnostics development. The availability of robust trial data will facilitate regulatory agency approval in industrialised countries and create markets for test developers.

• SDI must be a global effort: in order to succeed, a collaborative framework of private-public sector partnerships in developing and industrialised countries and functional links to other public sector and WHO STI activities is required.