Whole-Genome Sequencing to Predict Antimicrobial Susceptibility Profiles in Neisseria gonorrhoeae.

BACKGROUND: Neisseria gonorrhoeae is a major public health problem due to increasing incidence and antimicrobial resistance. Genetic markers of reduced susceptibility have been identified; the extent to which those are representative of global antimicrobial resistance is unknown. We evaluated the performance of whole-genome sequencing (WGS) used to predict susceptibility to ciprofloxacin and other antimicrobials using a global collection of N. gonorrhoeae isolates. METHODS: Susceptibility testing of common antimicrobials and the recently developed zolifodacin was performed using agar dilution to determine minimum inhibitory concentrations (MICs). We identified resistance alleles at loci known to contribute to antimicrobial resistance in N. gonorrhoeae from WGS data. We tested the ability of each locus to predict antimicrobial susceptibility. RESULTS: A total of 481 N. gonorrhoeae isolates, collected between 2004 and 2019 and making up 457 unique genomes, were sourced from 5 countries. All isolates with demonstrated susceptibility to ciprofloxacin (MIC ≤0.06 µg/mL) had a wild-type gyrA codon 91. Multilocus approaches were needed to predict susceptibility to other antimicrobials. All isolates were susceptible to zoliflodacin, defined by an MIC ≤0.25 µg/mL. CONCLUSIONS: Single marker prediction can be used to inform ciprofloxacin treatment of N. gonorrhoeae infection. A combination of molecular markers may be needed to determine susceptibility for other antimicrobials.

Effectiveness of Cefixime for the Treatment of Neisseria gonorrhoeae Infection at 3 Anatomic Sites: A Systematic Review and Meta-Analysis.

BACKGROUND: To treat Neisseria gonorrhoeae infection, the Centers for Disease Control and Prevention recommends a single oral dose of cefixime as an alternative to injectable ceftriaxone. METHODS: We conducted a systematic review and meta-analysis to describe the effectiveness of cefixime in treating N. gonorrhoeae infection at 3 different anatomic sites.We searched PubMed and Embase database to abstract treatment success rates and cefixime dosage/frequency for studies that reported the anatomical site of infection. We included reports published between January 1, 1980, and December 7, 2021. Twenty studies published between 1989 and 2015 were included in our meta-analysis. We calculated pooled treatment success percentages and 95% confidence intervals (CIs) using random-effects models. RESULTS: Of patients who received a 400-mg single dose of cefixime, 824 of 846 (97%; 95% CI, 96%-98%) patients with urogenital infection, 107 of 112 (97%; 95% CI, 84%-100%) patients with rectal infection, and 202 of 242 (89%; 95% CI, 76%-96%) patients with pharyngeal infection were cured. Of patients who received an 800-mg single dose of cefixime, 295 of 301 (98%; 95% CI, 96%-99%) patients with urogenital infection and 21 of 26 (81%; 95% CI, 61%-92%) patients with pharyngeal infection were cured. CONCLUSIONS: Our meta-analysis found that cefixime is highly effective at treating urogenital infections and less effective at treating pharyngeal infections. We recommend more investigation into the effectiveness of cefixime in treating rectal infections and studying multidose therapy for the cefixime treatment of pharyngeal infection.

Sexually transmitted infections among participants in an HIV PrEP adherence trial.

BACKGROUND: HIV PrEP effectiveness is highly dependent on adherence. High STI incidence has been reported among PrEP users. We assessed the relationship between STI incidence (CT, NG, and syphilis) and PrEP adherence. METHODS: We performed a subanalysis of a controlled, open-label, two-arm, randomized clinical demonstration project of a text-message based adherence intervention. Participants had 48 weeks of follow-up and had STI testing every 12 or 24 weeks. PrEP adherence was measured at week 48 using intracellular tenofovir-diphosphate drug concentrations. We calculated incidence rate ratios for STIs among those adherent as compared with those not adherent to PrEP. RESULTS: Of the 381 assessed for CT, NG and syphilis at one or more follow-up visits, there were 16 cases of syphilis or 5.0 per 100 person years (95% CI: 2.6, 7.5); 63 cases of NG or 26.3 per 100 person years (95% CI: 19.8, 32.8); and 81 cases of CT or 36.3 per 100 person years (95% CI: 28.4, 44.2). We found no association between adequate PrEP adherence and STI incidence (aIRR: 0.97 95% CI: 0.67, 1.40). CONCLUSIONS: We found that the incidence of STIs was not significantly different between those adherent to PrEP and those non-adherent. Further research is needed to assess how PrEP use may impact STIs over time.

72-Hour transport recovery of antimicrobial resistant Neisseria gonorrhoeae isolates using the InTray® GC method.

Recovery of Neisseria gonorrhoeae isolates exposed to a range of transport times and temperatures was quantitatively assessed for two transport devices, BioMed Diagnostics' InTray GC® and Copan Diagnostics' Liquid Amies Elution Swab (ESwab®) Collection and Transport System. Respective devices were inoculated with N. gonorrhoeae, exposed to simulated transport conditions and spread-plated from serial dilutions in duplicates onto chocolate agar in order to count CFU (colony-forming units) in the range of 25-250. Baseline CFU/mL averages of time-zero transport for each device was compared to either 24 hour (Eswab) or 72 hour (InTray GC) CFU/mL average to assess recovery of six clinical isolates of N. gonorrhoeae, and differences showing no greater than a 3 log10 (± 10%) decline between comparative time points qualified as acceptable. Our findings suggest that the InTray GC system has the potential to transport clinical isolates for ≤72 hours with acceptable N. gonorrhoeae recovery.

Adolescents may accurately self-collect pharyngeal and rectal clinical specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae infection.

BACKGROUND: The COVID-19 pandemic illuminated the benefits of telemedicine. Self-collected specimens are a promising alternative to clinician-collected specimens when in-person testing is not feasible. In this study, we assessed the adequacy of self-collected pharyngeal and rectal specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae among individuals undergoing chlamydia and gonorrhea screening. METHODS: We used data from a large cohort study that included male and female adolescents between the ages of 12-24 years. We considered self-collected specimens adequate for clinical use if the human synthase gene (a control target of the assay) was detected in the specimen. RESULTS: In total, 2,458 specimens were included in the analysis. The human synthase gene was detected in 99.2% (2,439/2,458) of all self-collected specimens, 99.5% (1,108/1,114) of the pharyngeal specimens, and 99.0% (1,331/1,344) of the rectal specimens. CONCLUSION: Self-collected pharyngeal and rectal specimens demonstrated a very high proportion of human gene presence, suggesting that self-collection was accurate. A limitation of this study is that the sample adequacy control detects the presence or absence of the human hydroxymethylbilane synthase gene, but it does not indicate the specific anatomic origin of the human hydroxymethylbilane synthase gene. Self-collected specimens may be an appropriate alternative to clinician-collected specimens.

Pooled 3-Anatomic-Site Testing for Chlamydia trachomatis and Neisseria gonorrhoeae: A Systematic Review and Meta-Analysis.

BACKGROUND: Pooled testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) may be a cost-saving solution to increase screening by simplifying testing procedures and reducing resource burdens. We conducted a systematic review and meta-analysis to examine the performance of pooled 3-anatomic-site testing (pharyngeal, rectal, and urogenital sites) for CT and NG in comparison with single-anatomic-site testing. METHODS: We conducted a systematic literature search in PubMed, Embase, and Web of Science to identify original evaluation studies of the performance of pooled testing for CT and NG infections and identified 14 studies for inclusion. Each study was systematically evaluated for bias. We conducted bivariate fixed-effects and random-effects meta-analyses using a full Bayesian method of the positive percent agreement and negative percent agreement. RESULTS: The combined positive percent agreement for CT was 93.11% (95% confidence interval [CI], 91.51%-94.55%), and the negative percent agreement was 99.44% (95% CI, 99.18%-99.65%). For NG, the combined positive percent agreement was 93.80% (95% CI, 90.26%-96.61%), and the negative percent agreement was 99.73% (95% CI, 99.30%-99.97%). CONCLUSIONS: We found that pooled 3-anatomic-site tests performed similarly to single-anatomic-site tests for the detection of CT and NG. The pooled 3-anatomic-site tests have the added potential benefit of reduced cost and resource requirement, which could lead to improved testing access and screening uptake.

The Performance of Pooled 3 Anatomic Site Testing for Chlamydia trachomatis and Neisseria gonorrhoeae Among Men Who Have Sex With Men and Transgender Women.

BACKGROUND: Although molecular testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) is highly sensitive, the cost can be prohibitive. Those high costs are amplified when the recommended screening approach is used, which requires separate testing of specimens from 3 anatomic sites (rectal, pharyngeal and urogenital). Although individual molecular testing is standard of care, pooled testing may offer a cost-saving alternative. METHODS: Using the Xpert® CT/NG assay (Cepheid, Sunnyvale, CA) we tested urine, rectal and pharyngeal swabs for CT and NG in a high-risk cohort of participants assigned male at birth who reported sex with other persons who were assigned male at birth. Remnant specimens (0.34 mL from each anatomic site) were combined to perform a single 'pooled' test. We calculated positive and negative percent agreement between the pooled testing results with standard of care Xpert CT/NG test results as the reference. RESULTS: We conducted 644 pooled tests. Of those, 598 (92.3%) gave CT and NG results. The CT-positive and -negative percent agreement were 90.1% (95% confidence interval [CI], 80.7-95.9%) and 99.2% (98.1-99.8%), respectively. The NG-positive and -negative percent agreement were 96.2% (95% CI, 86.8-99.5%) and 99.8% (95% CI, 99.0-100%), respectively. Pooled testing identified 4 CT and 1 NG infections that were negative at all anatomic sites by individual testing. CONCLUSIONS: Three-site pooled CT and NG testing performs similarly to single anatomic site testing among tests providing a valid result. Future cost analyses should evaluate the cost effectiveness of pooled 3-site testing to determine if such a strategy improves the feasibility and accessibility of molecular sexually transmitted infection testing.

Acceptability and feasibility of screening pregnant women for sexually transmitted infections in Rawalpindi, Pakistan.

Objectives: To understand the acceptability and feasibility of sexually transmitted infection (STI) testing during antenatal care, along with the prevalence of STIs, in Rawalpindi, Pakistan. Methods: We enrolled pregnant women seeking antenatal care and performed STI testing using Cepheid GeneXpert® CT/NG and TV kits and Alere Determine™ HIV and syphilis tests. We used interviewer-administered surveys to collect medical, social, and sexual histories. Participants testing positive for STIs and their partners were treated. Results: We enrolled 1001 women from September to December 2019. Nearly all women offered to participate in this study enrolled. Most women understood the effects an STI can have on their pregnancy (99.6%) and valued STI screening during pregnancy (98.1%). 11 women tested positive for any STI: (Chlamydia trachomatis = 4, Neisseria gonorrhoeae = 1, and Trichomonas vaginalis = 6). Of those, six presented for a test-of-cure, and two were positive for Trichomonas vaginalis. None tested positive for HIV infection or syphilis (n = 503). Conclusions: STI testing during antenatal care in Rawalpindi was acceptable, valued, understood, and feasible. The prevalence of STIs in pregnant women was low. Continued prevalence monitoring is warranted.

Impact of Testing on Sexually Transmitted Infections among Female Brothel Sex Workers in Bangladesh: A Randomized Controlled Trial.

Past studies that have designed interventions to reduce the prevalence of sexually transmitted infections (STIs) have typically provided onsite treatment to sex workers who tested positive, which were expensive and difficult to implement. The purpose of this study was to examine the effect of an intervention which tested for STIs and provided information on the closest treatment facility on reducing the prevalence of STIs among female brothel-based sex workers (BSWs) in Bangladesh. The study adopted a pre-post interventional design as well as a randomized controlled study design. A baseline sample and follow-up urine sample were collected to evaluate the prevalence of STIs among participants in the treatment, but not control group. A baseline survey and interviews were also conducted for both the groups. The study found a nonsignificant reduction from baseline to follow-up in STI prevalence among intervention participants (adjusted odds ratio [aOR]: 0.74; 95% CI: 0.38, 1.45). However, the participants in the intervention group were significantly more likely to have a repeat client (aOR: 1.60; 95% CI: 1.12, 2.29) and nonsignificantly less likely to engage with a client suspected of having an STI (aOR: 0.62; 95% CI: 0.39, 1.00) than participants in the control group. The intervention testing of STIs and providing information to the positive cases about nearest treatment facilities were not effective in reducing the prevalence of STIs among BSWs. Further study of the clinical and behavioral impacts of such efforts to reduce STIs among BSWs is warranted.

Prevalence of bacterial sexually transmitted infections and coinfection with HIV among men who have sex with men and transgender women in Tijuana, Mexico.

We estimated the prevalence of syphilis and Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections, as well as human immunodeficiency virus (HIV) coinfection among cisgender men who have sex with cisgender men (MSM) and transgender women (TW) in Tijuana, Mexico. MSM and TW (N = 212) recruited via respondent-driven and venue-based sampling for HIV testing underwent sexually transmitted infection (STI) testing and completed interviewer-administered surveys in this study (2017-2018). Treponemal rapid tests were used at the point-of-care with positives undergoing confirmatory testing following the reverse syphilis-testing algorithm. Nucleic acid amplification testing of urine and swabs (rectal and pharyngeal) was used to detect CT/NG at three anatomic sites. Chi-squared tests were used to compare STI prevalence by HIV status. Sexually transmitted infection prevalence was 39.6% overall but higher for newly diagnosed HIV-positive (55.7%; N = 88) than HIV-negative (28.2%; N = 124) participants (p-value < 0.0001). Among newly diagnosed HIV-positive participants, the prevalence of syphilis was 35.2% (31/88), CT infection was 27.3% (24/88; nine urethral; 16 rectal; four pharyngeal), and NG infection was 26.1% (23/88; six urethral; 19 rectal; nine pharyngeal). Among HIV-negative participants, the prevalence of syphilis was 12.1% (15/124), CT infection was 13.7% (17/124; seven urethral; nine rectal; two pharyngeal), and NG infection was 9.7% (12/124; three urethral; seven rectal; seven pharyngeal). Over 60% of all CT (25/41) and NG (26/35) infections in the full sample occurred extragenitally in the absence of urethral infections, and over 80% of rectal (30/37) and pharyngeal (16/18) infections were asymptomatic. The high prevalence of syphilis, CT, and NG infections among MSM and TW in Tijuana suggests STI screening that includes extragenital tests, particularly at HIV diagnosis, may help curb HIV/STI transmission.

Clinical Factors Associated With Accurate Presumptive Treatment of Neisseria gonorrhoeae Infections in Men Who Have Sex with Men and Transgender Women.

BACKGROUND: Neisseria gonorrhoeae (N. gonorrhoeae) infections have increased among men who have sex with men and are high among transgender women. Presumptive treatment guidelines may lead to inaccurate treatments and possible antibiotic resistance. Using patient data from AIDS Healthcare Foundation sexually transmitted infection (STI) testing clinics in California and Florida, we identified clinical factors associated with accurate presumptive N. gonorrhoeae treatment. METHODS: Multivariable logistic regression analyses were conducted using patient visit data from 2013 to 2017. A sample of 42 050 patient encounters were analyzed. The primary outcome variable included accurate versus inaccurate presumptive treatment. Risk ratios were generated for particular symptoms, high-risk sexual behavior, and history of N. gonorrhoeae. RESULTS: Twelve percent (5051/42 050) of patients received presumptive N. gonorrhoeae treatment, and 46% (2329/5051) of presumptively treated patients tested positive for N. gonorrhoeae infection. Patients presenting with discharge or patients presenting with dysuria were more likely to receive accurate presumptive treatment. CONCLUSIONS: Providers should continue to follow the Centers for Disease Control and Prevention guidelines and consider presumptive N. gonorrhoeae treatment based on specific symptoms. As the STI epidemic continues to rise in the United States, along with increased antibiotic resistance, it is imperative to accurately test, diagnose, and treat populations at risk for N. gonorrhoeae and other STIs.

Collateral Damage: A Narrative Review on Epidemics of Substance Use Disorders and Their Relationships to Sexually Transmitted Infections in the United States.

ABSTRACT: Associations between substance use disorders and outbreaks of HIV and acute viral hepatitis have received considerable attention, but less research has focused on links between substance use disorders and sexually transmitted infections, apart from alcohol misuse. This narrative review describes the history of this public health crisis in the United States and direct and indirect effects opioids and specific stimulants have on high-risk sexual behaviors. We also review the epidemiology of sexually transmitted infections associated with opioids and stimulants in the United States and discuss opportunities for integrated interventions.

Performance of a single-use, rapid, point-of-care PCR device for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: a cross-sectional study.

BACKGROUND: Timely detection and treatment are important for the control of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The objective of this study was to measure the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device. METHODS: Women aged 14 years and older who presented consecutively to ten clinical sites across seven US states were enrolled for a cross-sectional, single-visit study. Patients who consented to participate, and who had not used any exclusionary products in the genital area in the previous 48 h, provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using the guide provided. Specimens had to be run within 2 h of collection to be considered valid. For comparison, patient-infected status was derived by testing clinician-collected vaginal specimens with the Hologic Aptima Combo 2 Assay and Aptima Trichomonas vaginalis Assay, as well as the BD ProbeTec CT/GC Qx Amplified DNA Assay and BD ProbeTec Trichomonas vaginalis Qx Assay. If the results of those assays did not match, the BD MAX CT/GC/TV was used as a tiebreaker. The primary outcomes were the sensitivity and specificity of the investigational device for the detection of C trachomatis, N gonorrhoeae, and T vaginalis compared with patient-infected status. FINDINGS: Between Feb 25, 2019, and Jan 6, 2020, 1585 participants aged between 14 years and 80 years (mean 34·8 [SD 14·2]) were enrolled. 1555 participants had tests run with the investigational device, of whom 1532 (98·5%) had a valid result on either the first or repeat test. Among the patients with evaluable results (including a determinate patient-infected status), the device had a sensitivity of 97·6% (95% CI 93·2-99·2) and specificity of 98·3% (97·5-98·9) for C trachomatis (n=1457), sensitivity of 97·4% (86·5-99·5) and specificity of 99·4% (98·9-99·7) for N gonorrhoeae (n=1468), and sensitivity of 99·2% (95·5-99·9) and specificity of 96·9% (95·8-97·7) for T vaginalis (n=1449). INTERPRETATION: This innovative, rapid, easy-to-use, single-use, point-of-care device to detect C trachomatis, N gonorrhoeae, and T vaginalis infections showed excellent sensitivity and specificity, and could represent an important advance in the development of rapid diagnostics for sexually transmitted infections and other infectious diseases. FUNDING: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.

Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.

BACKGROUND: Novel treatment strategies to slow the continued emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae are urgently needed. A molecular assay that predicts in vitro ciprofloxacin susceptibility is now available but has not been systematically studied in human infections. METHODS: Using a genotypic polymerase chain reaction assay to determine the status of the N. gonorrhoeae gyrase subunit A serine 91 codon, we conducted a multisite prospective clinical study of the efficacy of a single oral dose of ciprofloxacin 500 mg in patients with culture-positive gonorrhea. Follow-up specimens for culture were collected to determine microbiological cure 5-10 days post-treatment. RESULTS: Of the 106 subjects possessing culture-positive infections with wild-type gyrA serine N. gonorrhoeae genotype, the efficacy of single-dose oral ciprofloxacin treatment in the per-protocol population was 100% (95% 1-sided confidence interval, 97.5-100%). CONCLUSIONS: Resistance-guided treatment of N. gonorrhoeae infections with single-dose oral ciprofloxacin was highly efficacious. The widespread introduction and scale-up of gyrA serine 91 genotyping in N. gonorrhoeae infections could have substantial medical and public health benefits in settings where the majority of gonococcal infections are ciprofloxacin susceptible. CLINICAL TRIALS REGISTRATION: NCT02961751.

Correlates of trichomoniasis among female sex workers who inject drugs in two Mexico-US border cities.

This paper evaluates correlates of trichomoniasis among female sex workers who inject drugs (FSWIDs) in two Mexico-US border cities. HIV-negative FSWIDs aged 18 years or older were enrolled in a study between 2008 and 2010 in Tijuana and Ciudad Juarez (Cd.), Mexico. All participants underwent a baseline interviewer-administered survey and did a rapid test for trichomoniasis. Using regression to estimate prevalence ratios, we examined sociodemographics, sex work characteristics, sexual health and behavior, substance use, and police and violence exposures as potential correlates of trichomoniasis. Of 584 women (284 in Tijuana, 300 in Cd. Juarez), prevalence of trichomoniasis was 33.6%. Factors associated with trichomoniasis in multivariable analysis were having money stolen by police in the past six months (adjusted prevalence ratio [aPR] =1.448, 95% confidence interval [CI] = 1.152-1.821), recent methamphetamine use (aPR = 1.432, CI = 1.055-1.944), lifetime syphilis infection (aPR = 1.360, CI = 1.061-1.743), ever use of a home remedy to treat vaginal symptoms (aPR = 1.301, CI = 1.027-1.649), and number of regular clients in the past month (aPR = 1.006 per client, CI = 1.004-1.009), while controlling for age and city of interview. Alongside the need for trichomoniasis surveillance and treatment programs, findings indicate that both structural and behavioral factors serve as primary correlates of trichomoniasis among FSWIDs in these cities.

Clinical Test Performance of a Rapid Point-of-Care Syphilis Treponemal Antibody Test: A Systematic Review and Meta-analysis.

We reviewed relevant syphilis diagnostic literature and conducted a meta-analysis to address the question, "What is the sensitivity and specificity of the Syphilis Health Check, a rapid qualitative test for the detection of human antibodies to Treponema pallidum." The Syphilis Health Check is the only rapid syphilis test currently cleared by the Food and Drug Administration (FDA). We conducted a systematic review and a meta-analysis using Bayesian bivariate random-effects and fixed-effect models to create pooled estimates of sensitivity and specificity of the Syphilis Health Check. We identified 5 test evaluations published in the literature and 10 studies submitted to the FDA and for a Clinical Laboratory Improvement Amendments waiver application. The pooled sensitivity (95% CI) from the laboratory evaluations (n = 5) was 98.5% (92.1-100%), while pooled specificity was 95.9% (81.5-100.0%). The pooled sensitivity for prospective studies (n = 10) was 87.7% ( 71.8-97.2%), while pooled specificity was 96.7% (91.9-99.2%). Using nontreponemal supplemental testing, the sensitivity improved to a pooled sensitivity of 97.0% (94.8-98.6%). The Syphilis Health Check may provide accurate detection of treponemal antibody.

Knowledge and testing preferences for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections among female undergraduate students.

Objective: Our goal was to evaluate knowledge and testing preferences for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) infections.Participants: We surveyed female undergraduates attending the University of California, Los Angeles, in May 2017.Methods: Using an online survey, we collected demographic information and information on 793 participants' health care seeking behavior, sexual activity, sexually transmitted infection (STI) knowledge, and STI screening preferences. We used conjoint analysis to evaluate testing preferences of hypothetical STI tests.Results: On knowledge questions of CT and NG infections, 193 (27.7%) participants scored >80% correct. Cost had the largest impact on willingness to use a hypothetical STI test, accounting for 41.5% of preference, followed by specimen type (17.4%), and location of testing (16.4%).Conclusions: Knowledge regarding STIs was low. Educational programs implemented through the university health center might increase testing rates. A free, urine-based, home STI test may be desirable for undergraduate females.

Sexually Transmitted Infections in Pregnancy and Reproductive Health: Proceedings of the STAR Sexually Transmitted Infection Clinical Trial Group Programmatic Meeting.

The goal of the STAR Sexually Transmitted Infection Clinical Trial Group (STI CTG) Programmatic meeting on Sexually Transmitted Infections (STIs) in Pregnancy and Reproductive Health in April 2018 was to review the latest research and develop recommendations to improve prevention and management of STIs during pregnancy. Experts from academia, government, nonprofit, and industry discussed the burden of STIs during pregnancy; the impact of STIs on adverse pregnancy and birth outcomes; interventions that work to reduce STIs in pregnancy, and the evidence, policy, and technology needed to improve STI care during pregnancy. Key points of the meeting are as follows: (i) alternative treatments and therapies for use during pregnancy are needed; (ii) further research into the relationship between the vaginal microbiome and STIs during pregnancy should be supported; (iii) more research to determine whether STI tests function equally well in pregnant as nonpregnant women is needed; (iv) development of new lower cost, rapid point-of-care testing assays could allow for expanded STI screening globally; (v) policies should be implemented that create standard screening and treatment practices globally; (vi) federal funding should be increased for STI testing and treatment initiatives supported by the Centers for Disease Control and Prevention (CDC), the Centers of Excellence in STI Treatment, public STD clinics, and the President's Emergency Plan for AIDS Relief (PEPFAR).

Meta-analysis of the Cepheid Xpert® CT/NG assay for extragenital detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections.

Background Most studies evaluating extragenital testing performance for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) detection by the Xpert® CT/NG show high per cent agreement with comparison assays; however, the precision around positive per cent agreement is low and thus the values that have been reported are not highly informative. Therefore, a systematic review was conducted and data from five studies were combined to better assess positive per cent agreement. METHODS: The literature indexed on PubMed.gov was searched. Included studies were those that were an evaluation of the Xpert CT/NG assay with rectal and/or pharyngeal specimen types compared with another nucleic acid amplification test (NAAT), the Aptima transcription mediated amplification assay. A full Bayesian method was used for bivariate fixed-effect meta-analysis of positive and negative per cent agreement and pooled estimates (and 95% confidence intervals (CI)) were presented for each. RESULTS: The pooled positive and negative per cent agreement for detection of CT in rectal specimens was 89.72% (95% CI: 84.97%, 93.64%) and 99.23% (95% CI: 98.74%, 99.60%), and in pharyngeal specimens, they were 89.96% (95% CI: 66.38%, 99.72%) and 99.62% (95% CI: 98.95%, 99.95%) respectively. For NG detection in rectal specimens, the pooled positive and negative per cent agreement was 92.75% (95% CI: 87.91%, 96.46%) and 99.75% (95% CI: 99.46%, 99.93%), and in pharyngeal specimens, they were 92.51% (95% CI: 85.84%, 97.18%) and 98.56% (95% CI: 97.69%, 99.23%) respectively. CONCLUSIONS: It was found that the Xpert CT/NG assay performed similarly to the Aptima transcription mediated amplification assay for the detection of CT and NG in extragenital specimens. The Xpert assay has the benefit of providing faster results at the point-of-care, thus reducing the turnaround time for results, potentially enabling same-day treatment.