A multicenter study compared ligase chain reaction (LCR) of Chlamydia trachomatis plasmid DNA with culture of urethral swab specimens from 542 men (study A); a second study (B) compared LCR of first-void urine (FVU) with urethral swab cultures from 1043 men. Discordant results were resolved with direct fluorescent antibody staining of sediments from the FVU or urethral culture specimen and with a second LCR directed against a fragment of the major outer membrane protein gene. Test performance was calculated on the basis of an expanded reference standard. The LCR plasmid assay had a sensitivity of 98.0% in study A and 93.5% in study B; specificity was 99.8%-100%. The sensitivity of culturing urethral swabs from all study sites was 68.2% (range by sites, 40.0%-84.6%). The presence or absence of urethral symptoms did not alter the results. Use of this LCR test should allow more meaningful investigation and treatment of C. trachomatis infections in men.
NAATs were performed on FCU, urethral, cervical, self-and clinician-collected VS. Sensitivity was compared to isolation using cervical and urethral swabs. Agreement of NAAT results between VS and cervical swabs or FCU was calculated. Specimens from 2,517 15-to 25-year-old asymptomatic women attending clinics at nine different centers were evaluated. Results with self-and clinician-collected VS were equivalent and were at least as good as results with FCU and cervical swabs. Across all sites, summary specificities for all specimens were >99%. Among culture-positive women, NAAT sensitivity with VS (93%) was as high as or higher than NAAT sensitivity with cervical swabs (91%) or FCU (80.6%) or culture of cervical swabs (83.5%). VS are appropriate specimens for diagnosing chlamydial genital tract infection by NAATs. That patients can efficiently collect them offers important benefits for screening programs. It would be beneficial for public health programs if the NAAT manufacturers sought FDA clearance for this specimen.
Quantitative bacteriology was performed on vaginal secretions from healthy adult women. The analysis included a single sample from 17 college students and 35 samples from five volunteers collected at intervals of three to five days throughout the menstrual cycle. Mean concentrations in all 52 specimens were 10(8.1) aerobic bacteria/g and 10(9.1) anaerobic bacteria/g. The rank of predominant organisms, according to rates of recovery in concentrations of greater than 10(5) colony-forming units/g, was anaerobic and facultative Lacrobacillus species, Peptococcus species, Bacteroides species, Staphylococcus epidermidis, Corynebacterium species, Peotostreptococcus species, and Eubacterium species. Sequential samples collected throughout the menstrual cycle showed relatively consistent mean levels of anaerobes and a significant decrease in concentrations of aerobes in premenstrual specimens compared with those in the specimens collected in the week following onset of menses. Analysis of sequential specimens from each of the five individuals showed considerable variation in species recovered. These data indicate that the vaginal flora in healthy adult women is a dynamic ecosystem in which anaerobes are usually the numerically dominant bacteria.
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