The need for rapid diagnostic tests

The high prevalence of asymptomatic gonococcal and chlamydial infections is one of the greatest obstacles to STI control, especially in developing countries, where partner notification is difficult. A widely available diagnostic test which allowed prompt and effective treatment of asymptomatic patients could reduce the prevalence of these infections, prevent complications, and reduce the incidence of HIV infection, whose transmission they facilitate. Such a test could also play an important part in reducing unnecessary treatment of patients with STI syndromes that are not caused by these pathogens.

In 1994 the Rockefeller Foundation offered a prize of US$1 million for the development of a simple, rapid point of care test for Neisseria gonorrhoeae and Chlamydia trachomatis infection.¹ To be eligible for the prize, the test had to meet rather exacting performance specifications. It had to be 99% specific for both infections, and to have a sensitivity of >90% for C trachomatis, and >95% for N gonorrhoeae, using non-invasive samples such as urine. Moreover, it had to be cheap (less than $0.25 to manufacture simple (reliable results obtained by a primary healthcare worker after less than 2 hours' training), rapid (less than 20 minutes), require no equipment, and be stable for several months at high ambient temperatures.

Not surprisingly, the prize was never claimed, and the offer has since been quietly withdrawn. However, the need for such a test remains as pressing as ever, and a number of other funding agencies—for example, the Wellcome Trust, the National Institutes of Health (NIH), and the Sexually Transmitted Diseases Diagnostics Initiative (SDI) have supported rapid …