DEVELOPMENT OF A SPECIES-SPECIFIC POLYMERASE CHAIN-REACTION ASSAY FORGARDNERELLA-VAGINALIS

The nucleotide sequence of the region between the 16S and 23S rRNA gen es of the facultative anaerobic bacterium Gardnerella vaginalis has be en determined, together with the 5' proximal 500 nucleotides of the 23 S rRNA gene. Regions suited for the development of specific, probe-con firmable polymerase chain reaction (PCR) assays were selected. PCR ass ays were evaluated with respect to sensitivity and specificity, the la tter in comparison with a number of G. vaginalis reference strains and closely related species like Bifidobacterium spp. In an initial diagn ostic study it appeared that the PCR test detected G. vaginalis in 40% of women irrespective of their clinical status. Ten out of 11 patient s suffering from bacterial vaginosis as defined on the basis of clinic al parameters were carrying G. vaginalis.