Newly available and future laboratory tests for sexually transmitted diseases (STDs) other than HIV

The development and introduction of nucleic acid amplification (NAA) tests by commercial sources has improved our ability to diagnose chlamydial infections and other sexually transmitted diseases (STDs). A review of approaches to diagnosing STDs can provide a clearer picture of the present needs.

To review the advantage and disadvantages of current and future diagnostic approaches.

Survey the literature and define current and future needs in developed and developing country settings.

The increase in analytical sensitivity afforded by NAA has enabled the use of noninvasive specimens, such as first-void urine (FVU) and self-obtained vaginal swabs, for diagnostic testing and screening asymptomatic low-prevalence populations and hard-to-access populations. This technology allows multiplexing in which targets from multiple agents responsible for a particular syndrome can be amplified and detected. Although NAA tests have been designed to minimize contamination, there is some reluctance to replace less sensitive tests with this new technology. The concerns involve potential false positive and false negative results caused by the presence of inhibitors, even though the rates of false results are low. Other concerns are cost, through-put, hands-on time, and time necessary for results.

Nucleic acid amplification tests are a great improvement and additional tests are needed for the diagnosis of STDs at the point of first encounter, with minimal delay between diagnosis and treatment. Affordable tests, which are rapid, sensitive, and specific are needed for use in resource-limited settings where most STDs are seen; this has been a major undertaking for the Sexually Transmitted Diseases Diagnostics Initiative.