Website

The SDI web site http://www.who.int/std_diagnostics has been launched. A unique feature of the web site is the sexually transmitted infections (STI) diagnostics publication review, the brainchild of Dr King Holmes, University of Washington, USA. The purpose of the publication review is to provide health care providers in all economic settings, but especially those in resource-limited settings, with timely and concise information about new developments in the laboratory diagnosis of STIs. This information is provided in the form of "annotated abstracts" of articles reporting original studies and reviews that evaluate new STI diagnostic assays that are commercially available and under-development. SDI would like to thank the experts in the field who have kindly agreed to be on our editorial board and have given valuable commentaries on articles sent to them for review.

Laboratory-based evaluations

Six rapid treponemal tests for syphilis have been evaluated for test performance, reproducibility and ease of use at 8 SDI laboratory sites using a common protocol and archived serum samples. The tests evaluated are: Abbott Determine Syphilis TP (USA), Diesse Syphilis Fast (Italy), Fujirebio Espline TP (Japan), Qualpro Syphicheck WB (India), Standard SD Bioline Syphilis 3.0 (Korea), and the Omega VisiTect Syphilis (Scotland). The laboratory sites are located in China, Gambia, Haiti, the Russian Federation, South Africa, Sri Lanka, Tanzania, and the USA. The results of this evaluation will be published in a report to be posted on the SDI web site in April, 2003. Written copies of the report will be available from SDI on request. Another round of laboratory-based evaluation of rapid syphilis diagnostics is planned for later this year.

Selection of rapid tests for SDI field trials

One of the aims of the laboratory evaluations is to prioritize tests for SDI field trials. The SDI ad hoc Expert Working Group on laboratory and field evaluations of rapid STI diagnostics reviewed the results of the laboratory-based evaluations for rapid syphilis tests, and selected 4 of the 6 syphilis tests evaluated to go into field trials. Since the performance of all 6 tests against the reference standard test (TPHA/TPPA) are acceptable, the decision was largely based on the ability of the tests to use whole blood and not requiring refrigeration for test reagents. The tests selected were Abbott Determine Syphilis TP (USA), Qualpro Syphicheck WB (India), Standard SD Bioline Syphilis 3.0 (Korea), and the Omega VisiTect Syphilis (Scotland).

Two chlamydia tests and 3 gonorrhea tests were evaluated in the SDI reference laboratory at the Institute of Tropical Medicine Microbiology Laboratory in Antwerp, Belgium. The two chlamydia tests are the ThermoBiostar OIA Chlamydia (USA) and the Unipath Clearview Chlamydia test (UK). The gonorrhea tests are the Binax Gc Now, ThermoBiostar OIA gonorrhea, the PATH gonorrhea test, all made in the USA. In the end, the consensus of the expert working group was that all 5 tests should be taken forward to field trials as the analytical sensitivities of these tests and their evaluation results using archived specimens were not sufficiently different to select one or two tests for the SDI field trials. The tests would be scheduled for sequential rather than head-to-head evaluation against a reference standard test in each field trial due to limitations on the number of swabs required of each patient.

Updates on preparations for field trials of rapid STI diagnostics 

Rapid tests selected from laboratory based evaluations will be evaluated in field settings at the following sites:

Evaluation Sites	Syphilis		Chlamydia	Gonorrhoea
	Prenatal	High risk
Africa:
Durban, S.A.
Mwanza, Tanzania
Cotonou, Benin
Asia:
Beijing, China
3 sites in India
Americas:
Port au Prince, Haiti
Manaus, Brazil
Europe:
Moscow, Russia

Of the 8 sites, 5 have obtained institutional, country and local ethical approval for conducting the trial. Training on the principles and practice of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) has been completed at 4 of the sites. Tests are currently being shipped to the sites and 3 of the sites are planning pilot runs of the trial in March-April 2003. It is expected that most of syphilis trials will be completed within 12-18 months.

Guidelines on the evaluation of rapid tests

In view of the lack of standardization in diagnostic evaluations, one of the priorities for SDI is the development of international standards for diagnostics evaluation. A small working group was formed by SDI last year to develop and draft guidelines for evaluation of rapid STI diagnostics. The aim is to publish very simple to use web and paper versions of documents that would provide a highly usable resource for the design and performance of diagnostic trials. Since there is interest in producing similar guidelines on diagnostics for other diseases, such as TB and malaria, it is expected that the STI draft document will be integrated into a single document with guidelines for other diseases and harmonized with existing recommendations on diagnostics evaluation and regulation from agencies such as those of the US Food and Drugs Administration and the European Union.

Upcoming STI meetings

The International Society for STD Research will be holding its biennial congress on July 27-30, 2003 in Ottawa, Canada. WHO will be sponsoring a symposium on WHO activities in the areas of STI surveillance, diagnostics and reproductive health. The 8th World STI/AIDS Congress will be held on December 2-5, 2003 in Punta del Este, Uruguay. This meeting is being held in conjunction with the XIV Panamerican STI/AIDS Congress and the 40th IUSTI World General Assembly.