Mycoplasmoides genitalium nucleic acid semi-quantitation and molecular macrolide resistance detection via automated assays: gender and specimen source considerations.

A laboratory-developed test (LDT) using analyte-specific reagents has been optimized on a commercial platform to detect macrolide resistance-associated mutations (MRM) in 23S rRNA from Mycoplasmoides genitalium from primary clinical specimens. In this study, MRM-LDT was applied to a multi-specimen source study set. One thousand four hundred ninety-five primary specimens testing positive for M. genitalium by commercial transcription-mediated amplification (TMA) were initially titered by the TMA assay using serial 10-fold dilutions to semi-quantitate target nucleic acid burden. Primary specimens were then processed for MRM detection using the MRM-LDT. Findings were stratified by gender and specimen source. The mean log10 target nucleic acid titer of a TMA-positive specimen was 3.51 (median 3; range 0-10). Male specimens (n = 1145) demonstrated a mean log10 M. genitalium TMA titer of 3.67; that value observed in 350 female specimens was 2.98 (P < 0.0001). The MRM-LDT detection rate (88.7%) from specimens with log10 M. genitalium TMA titers ≥ 4 was increased over specimens with log10 titers ≤ 1 (4.5%; P < 0.0002). In females, MRM-LDT was positive from 51.3% of vaginal swab and 34.7% of urine specimens (P = 0.01). In males, MRM-LDT was positive from 65.0% of rectal swab and 55.7% of urine specimens (P = 0.002). Differences were also observed in log10 M. genitalium TMA titers as a function of specimen source. M. genitalium macrolide resistance rates among multiple specimen sources, as determined by MRM-LDT, are high in the United States and can be consistent with target nucleic acid burden within the primary specimen. Caveats experienced within subgroupings support MRM reflex testing on primary M. genitalium-positive specimens. IMPORTANCE: First-line macrolide treatment failure is of increasing concern with Mycoplasmoides genitalium in multiple settings. Recent sexually-transmitted infection treatment guidelines from the United States Centers for Disease Control and Prevention have predicated therapeutic approaches on the availability of a macrolide resistance/susceptibility result from a primary clinical specimen. In this report, we investigate potential correlation between macrolide resistance mutation detection rates (identified by a molecular amplified laboratory-developed test) and transcription-mediated amplification-based rRNA target semi-quantitation. Data reveal that rRNA semi-quantitation and laboratory-developed test detection rate differences exist as a function of gender and specimen source. These data can guide providers in proper specimen selection not only for the laboratory diagnosis of M. genitalium but also macrolide resistance mutation determination from primary clinical specimens.

Congenital Syphilis in Live Births: Adverse Outcomes, Hospital Length of Stay, and Costs.

OBJECTIVE: To examine temporal trends and risk factors for congenital syphilis in newborn hospitalizations and to evaluate the association between adverse outcomes and congenital syphilis and health care utilization for newborn hospitalizations complicated by congenital syphilis. METHODS: We conducted a retrospective, cross-sectional study using data from the National Inpatient Sample to identify newborn hospitalizations in the United States between 2016 and 2020. Newborns with congenital syphilis were identified with International Classification of Diseases, Tenth Revision, Clinical Modification codes. Adverse outcomes, hospital length of stay, and hospital costs were examined. The annual percent change was calculated to assess congenital syphilis trend. A multivariable Poisson regression model with robust error variance was used to examine the association between congenital syphilis and adverse outcomes. Adjusted relative risks (RRs) with 95% CIs were calculated. A multivariable generalized linear regression model was used to examine the association between congenital syphilis and hospital length of stay and hospital costs. Adjusted mean ratios with 95% CIs were calculated. RESULTS: Of 18,119,871 newborn hospitalizations in the United States between 2016 and 2020, the rate of congenital syphilis increased over time (annual percent change 24.6%, 95% CI, 13.0-37.3). Newborn race and ethnicity, insurance, household income, year of admission, and hospital characteristics were associated with congenital syphilis. In multivariable models, congenital syphilis was associated with preterm birth before 37 weeks of gestation (adjusted RR 2.22, 95% CI, 2.02-2.44) and preterm birth before 34 weeks of gestation (adjusted RR 2.39, 95% CI, 2.01-2.84); however, there was no association with low birth weight or neonatal in-hospital death. Compared with newborns without congenital syphilis, hospital length of stay (adjusted mean ratio 3.53, 95% CI, 3.38-3.68) and hospital costs (adjusted mean ratio 4.93, 95% CI, 4.57-5.32) were higher among those with congenital syphilis. CONCLUSION: Among newborn hospitalizations in the United States, the rate of congenital syphilis increased from 2016 to 2020. Congenital syphilis was associated with preterm birth, longer hospital length of stay, and higher hospital costs.