Use of molecular diagnostics in sexually transmitted diseases. Critical assessment.

This review describes and assesses the use of molecular assays for the diagnosis of sexually transmitted diseases (STDs). Specifically, data from literature on currently available commercial systems as well as that of imminently to be released assay formats are presented. The focus is on evaluations of two molecular diagnostic techniques--hybridization and amplification for the direct detection of Chlamydia trachomatis and Neisseria gonorrhoeae (gonococci, GC)--the use of urine as a specimen for the diagnosis of these pathogens in humans, a confirmatory probe assay for GC, and finally the description of a hybridization assay for pathogens significant in vaginitis and bacterial vaginosis. Although viral pathogens are a significant part of the STD problem, and molecular techniques have been described for their identification, they are not being discussed here. With the exception of the Virapap DNA hybridization assay for human papillomavirus (Digene Diagnostic, Silver Spring, MD), suitable molecular clinical laboratory assays for viral detection have not been developed for genital samples.