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Background: Cervical cancer, primarily from HPV, is prevalent in countries like Mozambique, with HIV individuals at higher risk. The Visual Inspection with Acetic Acid (VIA) screening method can be influenced by STIs like Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This study examines CT and NG prevalence in HIV-positive and negative women using VIA in Mozambique's DREAM program., Methods: In this cross-sectional research conducted at a DREAM program facility in Maputo from 01/07/2021 to 31/05/2022, cervical specimens were taken from VIA-positive patients. CT/NG testing was performed using the Cobas® 4800 DNA CT/NG test. Statistical analyses focused on associations and prevalence rates, considering demographic, clinical, and exposure data., Results: Among 117 women, we observed a CT prevalence of 6.8% (8/117) and an NG prevalence of 2.6%(3/117). No significant associations between CT/NG infection rates and factors such as age, HIV status, VIA results, or high-risk HPV (hrHPV) was observed. We found a 47% prevalence of hrHPV infections among participants with cervical lesions; no significant association between hrHPV and CT/NG infections was observed., Conclusion: This study highlights the prevalence of CT and NG in VIA-positive women in Mozambique, emphasizing the STI burden and suggesting integration of STI screening in cervical cancer prevention strategies., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Sexually transmitted infections (STIs) are on the rise in the United States. Infections at extragenital (EG) sites (throat or rectum) may serve as an overlooked reservoir for STIs. The aims of this project were to determine the proportion of patients receiving EG testing and to observe the impact of an educational intervention., Methods: Phase I included four urgent care clinics and baseline data for adults receiving STI testing ( Chlamydia trachomatis and Neisseria gonorrhoeae ). Clinics received access to an educational presentation regarding the importance of EG testing. Two of these clinics served as pilot sites for the implementation of self-collection kits. Phase II involved further expansion and utilization of clinic site champions., Results: Phase I baseline data indicated that less than 1% of samples from patients receiving STI testing were from EG sites. There was an increase in EG testing after the educational intervention and implementation of self-collection kits. A larger increase in EG testing was seen after utilization of a site champion in Phase II., Conclusion: EG infections serve as a potential source for STI transmission which makes multi-site testing necessary. Our interventions to improve EG testing were most effective in Phase II after implementing a clinic site champion., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Ureaplasma urealyticum (UU) are the common sexually transmitted pathogens and lead to genital diseases, highly prevalent all around the world. The objective of this study was to analyze the prevalence of NG, CT and UU among outpatients in central China. A total of 2186 urogenital swabs were collected from the patients and the NG, CT and UU pathogens were testing with RT-PCR method, meanwhile the medical records were obtained from the hospital information system. The overall infection rates of NG, CT and UU were 4.57 %, 6.63 % and 48.81 % respectively, showed the prevalence of UU was higher than NG and CT. The younger people had the highest infection rate of NG (10.81 %), CT (20.54 %) and UU (54.59 %). Single infection (89.09 %) was significant higher than co-infection (10.91 %), and the CT-UU co-infection was the prominent pattern (66.41 %). There were an obvious sex difference, the prevalence of NG and CT were significant higher in male, whereas UU was higher in female. Our study could contributed a better understanding of the prevalence of NG, CT and UU, facilitating to the development of effective screening, prevention and treatment policies., Competing Interests: Declaration of competing interest We declare that we have no financial and personal relationships with other people or organizations., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: Chlamydia trachomatis (Ct) and Neisseria gonorrhoeae (Ng) infections are often asymptomatic; screening increases early detection and prevents disease, sequelae and further spread. To increase Ct and Ng testing, several countries have implemented specimen self-collection outside a clinical setting. While specimen self-collection at home is highly acceptable to patients and as accurate as specimens collected by healthcare providers, this strategy is new or not being used in some countries. To understand how offering at home specimen self-collection will affect testing uptake, test results, diagnosis and linkage to care, when compared with collection in clinical settings, we conducted a systematic literature review and meta-analysis of peer-reviewed studies., Methods: We searched Medline, Embase, Global Health, Cochrane Library, CINAHL (EBSCOHost), Scopus and Clinical Trials. Studies were included if they directly compared specimens self-collected at home or in other non-clinical settings to specimen collection at a healthcare facility (self or clinician) for Ct and/or Ng testing and evaluated the following outcomes: uptake in testing, linkage to care, and concordance (agreement) between the two settings for the same individuals. Risk of bias (RoB) was assessed using Cochrane Risk of Bias (RoB2) tool for randomised control trials (RCTs)., Results: 19 studies, from 1998 to 2024, comprising 15 RCTs with a total of 62 369 participants and four concordance studies with 906 participants were included. Uptake of Ct or Ng testing was 2.61 times higher at home compared with clinical settings. There was a high concordance between specimens collected at home and in clinical settings, and linkage to care was not significantly different between the two settings (prevalence ratio 0.96 (95% CI 0.91-1.01))., Conclusion: Our meta-analysis and systematic literature review show that offering self-collection of specimens at home or in other non-clinical settings could be used as an additional strategy to increase sexually transmitted infection testing in countries that have not yet widely adopted this collection method., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objectives: The impact of the systematic screening of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in men having sex with men (MSM) on these pathogens' epidemiology remains unclear. We conducted a modelling study to analyse this impact in French MSM., Methods: We modelled NG and CT transmission using a site-specific deterministic compartmental model. We calibrated NG and CT prevalence at baseline using results from MSM enrolled in the Dat'AIDS cohort. The baseline scenario was based on 1 million MSM, 40 000 of whom were tested every 90 days and 960 000 every 200 days. Incidence rate ratios (IRRs) at steady state were simulated for NG, CT, NG and/or CT infections, for different combinations of tested sites, testing frequency and numbers of frequently tested patients., Results: The observed prevalence rate was 11.0%, 10.5% and 19.1% for NG, CT and NG and/or CT infections. The baseline incidence rate was estimated at 138.2 per year per 100 individuals (/100PY), 86.8/100PY and 225.0/100PY for NG, CT and NG and/or CT infections. Systematically testing anal, pharyngeal and urethral sites at the same time reduced incidence by 14%, 23% and 18% (IRR: 0.86, 0.77 and 0.82) for NG, CT and NG and/or CT infections. Reducing the screening interval to 60 days in frequently tested patients reduced incidence by 20%, 29% and 24% (IRR: 0.80, 0.71 and 0.76) for NG, CT and NG and/or CT infections. Increasing the number of frequently tested patients to 200 000 reduced incidence by 29%, 40% and 33% (IRR: 0.71, 0.60 and 0.67) for NG, CT and NG and/or CT infections. No realistic scenario could decrease pathogens' incidence by more than 50%., Conclusions: To curb the epidemic of NG and CT in MSM, it would not only be necessary to drastically increase screening, but also to add other combined interventions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To evaluate the impact of screening and treating asymptomatic pregnant women for Chlamydia (C.) trachomatis and Neisseria (N.) gonorrhoeae infections on the frequency of preterm birth or low birthweight infants in Botswana., Design: Non-randomised, cluster-controlled trial., Setting: Four antenatal care clinics in Gaborone, Botswana., Population: Pregnant women aged ≥15 years, attending a first antenatal care visit, ≤27 weeks of gestation and without urogenital symptoms were eligible., Methods: Participants in the intervention clinics received screening (GeneXpert®, Cepheid) during pregnancy and at the postnatal visit. Participants in the standard-of-care clinics received screening at the postnatal visit only. We used multivariable logistic regression and post-estimation predictive margins analysis. Post-hoc analysis was conducted among sub-samples stratified by parity., Main Outcome Measures: Preterm birth (<37 weeks of gestation) and low birthweight (<2500 g)., Results: After controlling for parity, hypertension, antenatal care visits and clinic site, the predicted prevalence of preterm birth or low birthweight was lower in the intervention arm (11%) compared with the standard-of-care arm (16%) (adjusted odds ratio [aOR] 0.59; 95% confidence interval [CI] 0.28-1.24). In post-hoc analysis, the intervention was more effective than the standard-of-care (aOR 0.20; 95% CI 0.07-0.64) among nulliparous participants., Conclusion: A C. trachomatis and N. gonorrhoeae infection screening and treatment intervention among asymptomatic pregnant women may have reduced preterm birth or low birthweight outcomes, but results were not statistically significant. Post-hoc analysis found that the intervention reduced adverse outcomes among nulliparous participants., (© 2024 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

This study aimed to know the opinion of professionals participating in an experiment to implement a pilot for molecular tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae at the Brazilian Unified National Health System (SUS). The detection rate of C. trachomatis and/or N. gonorrhoeae and the factors associated with infection were determined. The strategy included laboratories belonging to the HIV and viral hepatitis viral load network. Testing targeted people who are more vulnerable to sexually transmitted infections and collected urine samples and/or vaginal, endocervical, and/or male urethral swabs. Questionnaires were sent to state managers and laboratory professionals about the implementation of the pilot. Reviews were overall positive. Weaknesses included difficulties changing work processes, lack of human resources, poorly sensitized care professionals, and absence of primary urine tubes, the only input not provided. Strengths included the centralized acquisition of tests, sharing of equipment, and storage of samples at room temperature. Of the 16,177 people who were tested, 1,004 (6.21%) were positive for C. trachomatis; 1,036 (6.4%), for N. gonorrhoeae; and 239 (1.48%), for C. trachomatis/N. gonorrhoeae . Detection of any infection occurred more frequently in young people (≤ 24 vs. > 24 years) (adjOR = 2.65; 95%CI: 2.38-2.96), men (adjOR = 1.95; 95%CI: 1.72-2.21), brown/black individuals (adjOR = 1.06; 95%CI: 1.05-1.11), those in Southeastern Brazil (adjOR = 1.08; 95%CI: 1.02-1.13), and in urethral secretion samples (adjOR = 1.46; 95%CI: 1.41-1.52). Results show the importance of making testing available nationwide, which supported the implementation of a definitive network to detection C. trachomatis/N. gonorrhoeae in SUS.

Home sample collection for sexually transmitted infection (STI) screening options can improve access to sexual healthcare across communities. For Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), genital infections have classically been the focus for remote collection options. However, infections may go undiagnosed if sampling is limited to urogenital sites because some individuals only participate in oral and/or anal intercourse. Here we evaluated samples for CT/NG detection after several pre-analytical collection challenges. A paired provider to self-collection validation was performed on rectal [ n = 162; 22 + for CT and 9 + for NG by provider-collected (PC)] and throat ( N = 158; 2 + for CT and 11 + for NG by provider-collected) swabs. The positive percent agreement for CT and NG ranged from 90.9% to 100%. The discrepancies were more often positive on self-collected (SC) ( n = 9 SC+/PC-; n = 1 PC+/SC-; n = 1 PC+/SC Equiv.; n = 2 PC-/SC Equiv.). An empirical limit of detection (LoD) lower than the manufacturer's claim (0.031 vs 2.5 IFU/mL for CT and 0.063 vs 124.8 CFU/ml for NG, respectively) was used to challenge additional variables. Common hand contaminants, including soap, hand sanitizer, lotion, and sunscreen were added to known positive (3× empirical LoD) or negative samples and did not influence detection. Samples at 2× and 10× the empirical LoD were challenged with extreme temperature cycling and extended room temperature storage. Detection was not affected by these conditions. These results indicate that remote self-collection is an appropriate method of sample acquisition for detecting extragenital CT/NG infections. Additionally, they provide a foundation towards meeting the regulatory standards for commercial testing of home collected extragenital samples., Importance: There is a clinical need for expanded extragenital bacterial sexually transmitted infection (STI) testing options, but the current regulatory landscape limits the wide-spread promotion and adoption of such services. Improved access, particularly for the LGBTQ+ community, can be achieved by validating testing for specimens that are self-collected at a remote location and arrive at the laboratory via a postal carrier or other intermediary route. Here we provide valuable data showing that self-collected samples for anal and oropharyngeal STI testing are equally or increasingly sensitive compared with those collected by a provider. We systematically consider the effects of storage time, exposure to temperature extremes, and the addition of common toiletries on results., Competing Interests: At the time of writing, B.E.H., R.A.M., and D.N.G. received salary compensation from LetsGetChecked. D.N.G. additionally received scientific advisory compensation from Abbott Diagnostics.

Background: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are routinely tested and reported; however, Trichomonas vaginalis (TV) is the most common sexually transmitted infection (STI) in the United States and the prevalence of Mycoplasma genitalium (MG) infections is likely higher than estimated. We examined the clinical performance of the Alinity m STI assay for detection and surveillance of CT/NG/TV/MG in urine specimens from patients at a large academic medical center., Methods: Urine specimen from 198 patients was tested in this evaluation. Alinity m STI and Aptima Combo 2 CT/NG and TV assay (Panther System) results were compared, with discrepant results run on the cobas 6800 CT/NG, TV/MG assays. Analyzer turnaround times, time from loading the specimen on the analyzer to results reporting, were determined for Alinity m and Panther systems., Results: Overall percent agreements of the Alinity m in comparison with the Aptima and cobas assays for CT, NG, TV, and MG were 99.5% (97.2%, 99.9%), 99.5% (97.2%, 99.9%), 98.4% (95.5%, 99.5%), and 86.4% (66.7%, 95.3), respectively. There were 5 discrepant samples (CT, 1; NG, 1; TV, 3) between the Alinity m and the Aptima assays, and 3 MG discrepant samples between the Alinity m STI and cobas 6800. Two of the 5 Aptima and Alinity m discrepant samples were resolved as they yielded similar results on both Alinity m and cobas 6800. TV and MG infections comprised 54% of the positive samples and were more often asymptomatic than CT and NG infections. Analyzer turnaround time was 3 hours 25 minutes for the Aptima CT/NG, 3 hours 25 minutes for Aptima TV, and 1 hour 55 minutes for Alinity m STI assay., Conclusions: The Alinity m STI assay allows for fast and simultaneous detection of the 4 major STI pathogens, which can facilitate surveillance and provide accurate results to help clinicians diagnose for initiation of appropriate treatment., Competing Interests: Conflict of Interest and Sources of Funding: J.K. is an employee of Abbott Laboratories. This study was funded by a grant from Abbott Laboratories., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Background: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are the most common bacterial sexually transmitted infections (STIs) worldwide. These STIs are frequently asymptomatic, which often delays diagnosis and treatment with the risk of serious long-term complications. Current French recommendations call for targeted screening of populations considered to be at risk, including victims of sexual assault. However, no recent data on the prevalence of these STIs in this population are available in France. The aim of this study was therefore to determine the prevalence of CT/NG infections among victims of sexual assault attending three Clinical Forensic Units (CFUs)., Methods: We retrospectively reviewed the forensic records of patients aged over 12 years reporting a sexual assault and referred between January 1, 2020 and December 31, 2021 to the CFU of Montpellier, Angers or Saint-Denis de La Réunion. Patients who had been screened for CT and NG infections were included., Results: 341 alleged victims of sexual assault (324 women, 17 men, median age = 23 years) were screened for CT/NG STIs during the inclusion period (Montpellier, n=196; Angers, n=63; Saint-Denis, n=82). The median time between the sexual assault and the examination was 1 day. CT and NG were detected in 28 patients (8.2 %) and 8 patients (2.3 %) respectively, with no men tested positive. Positive results concerned genital samples, except for two CT-positive anorectal samples and one NG-positive oropharyngeal sample. Two patients (0.6 %) were co-infected with CT/NG. The overall prevalence of CT/NG STIs was 10.0 % and was higher in the 18-24 age group, reaching 13.2 % for CT., Conclusions: This multicenter study confirms the high prevalence of CT/NG STIs in victims of sexual assault, and the vulnerability of the youngest age groups to these infections. Systematic screening for CT/NG STIs at the time of the forensic examination is the key to early diagnosis and effective treatment to prevent transmission and subsequent complications in these patients., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are prevalent causes of sexually transmitted infections (STIs) globally, leading to substantial morbidity and transmission risks., Methods: This study evaluates the diagnostic efficacy of Xpert CT/NG compared to conventional PCR and culture methods in 121 patients at a tertiary care centre in North India., Results: Xpert CT/NG demonstrated high sensitivity (85.8%) and specificity (96.3%) outperforming conventional PCR. Xpert CT/NG's rapidity and accuracy underscore its utility in timely diagnosis and control of STIs., Conclusion: As sexually transmitted infections pose a serious health concern implementation of such rapid diagnostic methods/point of care testing methods are to be implemented for early diagnosis., (Copyright © 2024 Indian Association of Medical Microbiologists. Published by Elsevier B.V. All rights reserved.)

Background: Sexually transmitted infections (STIs) are a public health problem. The aim of the present study was to assess the prevalence and risk factors associated with at least one STI (Chlamydia trachomatis [CT], Neisseria gonorrhoeae [NG], Trichomonas vaginalis [TV], and Mycoplasma genitalium [MG]) in Brazil., Methods: A cross-sectional study was conducted using secondary data from the pilot implementation of the National Service for molecular diagnosis of CT, NG, TV, and MG in pregnancy. We obtained Ministry of Health surveillance data from the implementation project. Data encompassing pregnant women aged 15-49 years from public antenatal clinics in Brazil in 2022 were included., Results: A total of 2728 data of pregnant women were analyzed. The prevalence of at least one infection was 21.0% (573), with the highest prevalence in the Southeast region (23.3%) and the lowest in the Center-West region (15.4%). The prevalence of CT was 9.9% (270), NG 0.6% (16), TV 6.7% (184), and MG 7.8% (212). Factors associated with any infection were from 15 to 24 years (AOR = 1.93; 95% CI: 1.58-2.35); reported family income up to US$400 (AOR = 1.79; 95% CI: 1.03-3.34); declared not living maritally with their partners (AOR = 1.90, 95% CI: 1.52-2.37) and had more than one sexual partner in their lifetime (AOR = 2.09, 95% CI: 1.55-2.86)., Conclusion: This study showed a high prevalence of at least one STI among pregnant women in Brazil, particularly among younger women. It also provides up-to-date national data on CT, NG, TV, and MG infections in this population. These findings underscore the importance of enhancing access to STI screening for young pregnant women within the Brazilian public health system., (© 2024 International Federation of Gynecology and Obstetrics.)

Background: Rectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections among men who have sex with men (MSM) are escalating public health concerns. This study aimed to explore (1) the reliability of self-reported sexual positioning as an indicator for rectal CT and NG screening, and (2) factors associated with rectal CT and NG infections in Shenzhen, China., Methods: A cross-sectional study was conducted in 2 settings in Shenzhen, China, from April 1, 2021, to March 31, 2022. Data on sociodemographic characteristics, sexual behaviors, and basic CT knowledge were collected. Urine and self-collected rectal swabs were collected for CT and NG testing., Results: In total, 195 MSM participated in the study, and 5.1% tested positive for urogenital CT, 29.2% for rectal CT, 1.0% for urogenital NG, and 8.2% for rectal NG. Among those who reported exclusively insertive anal sex, 69.2% of CT infections and 85.7% of NG infections would have remained undetected with urine testing alone. Risk factors for rectal CT infection included engaging in both insertive and receptive anal sex, with a significant association found for coinfection with rectal NG., Conclusions: Self-reported sexual positioning was found to be an unreliable indicator for CT and NG screening, as a substantial proportion of infections would have remained undetected. The findings suggest that CT and NG screening in China should be offered to all MSM regardless of self-reported sexual positioning, and that the dual CT/NG testing is recommended., Competing Interests: Conflict of Interest and Sources of Funding: The authors declare no conflict of interest. This study was supported by the Sanming Project of Medicine in Shenzhen (No. SZSM201611077)., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Standard-of-care nucleic acid amplification tests (routine NAATs) for Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) can take several days to result and therefore delay treatment. Rapid point-of-care GC/CT NAAT (rapid NAAT) could reduce the time to treatment and therefore onward transmission. This study evaluated the incremental cost per infectious day averted and overall cost of implementation associated with rapid compared with routine NAAT., Methods: Prospective sexually transmitted infection (STI) treatment data from men who have sex with men and transgender women in San Diego who received rapid NAAT between November 2018 and February 2021 were evaluated. Historical time from testing to treatment for routine NAAT was abstracted from the literature. Costs per test for rapid and routine NAAT were calculated using a micro-costing approach. The incremental cost per infectious day averted comparing rapid to routine NAAT and the costs of rapid GC/CT NAAT implementation in San Diego Public Health STI clinics were calculated., Results: Overall, 2333 individuals underwent rapid NAAT with a median time from sample collection to treatment of 2 days compared with 7 to 14 days for routine NAAT equating to a reduction of 5 to 12 days. The cost of rapid and routine GC/CT NAAT was $57.86 and $18.38 per test, respectively, with a cost-effectiveness of between $2.43 and $5.82 per infectious day averted. The incremental cost of rapid NAAT improved when at least 2000 tests were performed annually., Conclusions: Although rapid GC/CT NAAT is more expensive than routine testing, the reduction of infectious days between testing and treatment may reduce transmission and provide improved STI treatment services to patients., Competing Interests: Conflict of Interest and Sources of Funding: S.J.L. has received funding from Gilead Sciences paid to her institution and donation of medications from Gilead Sciences. E.W., T.C.S.M., N.K.M., and W.T. have no conflicts of interest to disclose., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Introduction: The rates of gonorrhea and chlamydia have been increasing in the years preceding the COVID19 pandemic. Because most gonorrhea and chlamydia infections are located in the oropharynx and rectum for men who have sex with men (MSM), and because at-home self-collected swabs for these infections are not licensed by Health Canada or the United States Food and Drug Administration, decreased accessed to in-person care during and since the COVID19 pandemic potentially means missed case findings., Objectives: To evaluate the performance of at-home self-collected pharyngeal and rectal swabs for gonorrhea and chlamydia nucleic acid amplification testing., Methodology: All persons who contacted our Sexual Health Clinic and who had a clinical indication to complete oral and/or rectal swabs for gonorrhea and chlamydia were invited to complete at-home swabs in advance of their scheduled appointments. We mailed swabs and instructions to those who consented. Participants brought these swabs to their scheduled in clinic appointments, where we repeated the same swabs. All matching swabs were sent to the laboratory for analysis to determine concordance., Results: From September 8, 2022 to July 18, 2023, we enrolled 296 eligible participants who provided 1184 swabs. For analysis, cancelled specimens and specimens with invalid results were excluded, leaving 1032 swabs for comparison. We identified 66 STI diagnoses in 47 unique participants. Overall accuracy was high (exceeding 99%), except for rectal chlamydia, which was 96.0%. While the performance of self-swabs for chlamydia was lower compared to gonorrhea, at-home swabs identified six chlamydia infections that were missed by in-clinic collected swabs (two pharyngeal, four rectal). Removing these six cases as "false positives" increased overall accuracy for chlamydia detection to 99.7% (pharyngeal) and 97.8% (rectal)., Conclusion: Self-collected at-home swabs had good performance acceptable for gonorrhea and chlamydia nucleic acid amplification testing., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Orser et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Sexually transmitted diseases (STDs) are a global concern because approximately 1 million new cases emerge daily. Most STDs are curable, but if left untreated, they can cause severe long-term health implications, including infertility and even death. Therefore, a test enabling rapid and accurate screening and genotyping of STD pathogens is highly awaited. Herein, we present the development of the DNA-based 6STD Genotyping 9G Membrane test, a lateral flow strip membrane assay, for the detection and genotyping of six STD pathogens, including Trichomonas vaginalis , Ureaplasma urealyticum , Neisseria gonorrhoeae , Chlamydia trachomatis , Mycoplasma hominis , and Mycoplasma genitalium . Here, we developed a multiplex PCR primer set that allows PCR amplification of genomic materials for these six STD pathogens. We also developed the six ssDNA probes that allow highly efficient detection of the six STD pathogens. The 6STD Genotyping 9G Membrane test lets us obtain the final detection and genotyping results in less than 30 m after PCR at 25 °C. The accuracy of the 6STD Genotyping 9G membrane test in STD genotyping was confirmed by its 100% concordance with the sequencing results of 120 clinical samples. Therefore, the 6STD Genotyping 9G Membrane test emerges as a promising diagnostic tool for precise STD genotyping, facilitating informed decision-making in clinical practice.

Purpose: Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Mycoplasma hominis (MH), the three most common treatable bacterial sexually transmitted infections (STIs) worldwide can lead to many complications if remain untreated. Screening of high-risk population with highly sensitive methods will lead to significant improvement in patient outcomes and will prevent downward transmission. The advantages of Polymerase chain reaction (PCR) based assay are not only high sensitivity and specificity, but also detection of multiple organisms in a single reaction which reduce the result turn-around time. The aim of the present study was to evaluate the feasibility of a multiplex PCR assay method targeting 16S rRNA gene for simultaneous detection of NG, CT and MH infection along with their trend and occurrence among high-risk population in Assam, Northeast India., Methods: A cross-sectional study was undertaken, where a total of 200 randomly selected patients from high-risk population were included. After validation of singleplex PCR, Multiplex PCR (M-PCR) was performed along with the traditional culture method for NG., Results & Conclusion: The overall agreement of M-PCR with singleplex PCR was very high (100%). The occurrence of STI was found to be very high (101/200; 50.5%). Furthermore, co-infection was detected in 10/200; 5%) individuals. Infection was more common among young individuals (p < 0.05) and males out-numbered females (p < 0.05). The most common organism detected was CT (42/200; 21%) followed by NG (41/200; 20.5%) and MH (20/200; 10%). The M-PCR assay workflow is simple, cost effective and can be used in routine diagnostic laboratories with basic molecular facilities., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Lahari Saikia reports administrative support and equipment, drugs, or supplies were provided by Assam State AIDS Control Society (ASACS), Govt. of Assam. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Indian Association of Medical Microbiologists. Published by Elsevier B.V. All rights reserved.)

Despite significant research on the prevalence of STIs in South African men who have sex with men (MSM), recent data on the prevalence and risk factors for curable STI infections among this key populations are limited. This study determined the prevalence of and risk factors associated with Neisseria gonorrhoeae and Chlamydia trachomatis infections among MSM. The sample consisted of 200 MSM resident in Durban. Data were collected using a self-administered questionnaire, and urine samples were collected and tested for N. gonorrhoeae and C. trachomatis. The prevalence of N. gonorrhoeae and C. trachomatis were 3.0% and 6.0%, respectively. Younger age was significantly associated with testing positive for C. trachomatis (p=0.037). Being between the ages of 30-39 years old reduced the risk of acquiring C. trachomatis infection (OR: 0.10, 95% CI: 0.0120-0.7564, p=0.026). In addition, being circumcised reduced the risk of contracting C. trachomatis (adjusted OR: 0.01, 95% CI: 0.0005-0.3516, p=0.01). However, having between 2-4 sex partners increased the risk of testing positive for C. trachomatis (adjusted OR: 107.45, 95% CI: 1.3467-8573.3130, p=0.036). The following factors were significantly associated (p<0.05) with testing positive for N. gonorrhoeae infection: cohabiting with sex partner, engaging in group sex, and drug use. Fear and stigma were the main barriers to accessing health care in the studied population. This study provided evidence of high rates of C. trachomatis infection among MSM resident in Durban. Based on the results, South African MSM, especially the young MSM population, should be given priority when delivering intervention programs to prevent STIs., Competing Interests: The Authors declared no conflict of interest, (African Journal of Reproductive Health © 2024.)

Background: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) resulted in over 200 million new sexually transmitted infections last year. Self-sampling strategies alone or combined with digital innovations (ie, online, mobile or computing technologies supporting self-sampling) could improve screening methods. Evidence on all outcomes has not yet been synthesised, so we conducted a systematic review and meta-analysis to address this limitation., Methods: We searched three databases (period: 1 January 2000-6 January 2023) for reports on self-sampling for CT/GC testing. Outcomes considered for inclusion were: accuracy, feasibility, patient-centred and impact (ie, changes in linkage to care, first-time testers, uptake, turnaround time or referrals attributable to self-sampling).We used bivariate regression models to meta-analyse accuracy measures from self-sampled CT/GC tests and obtain pooled sensitivity/specificity estimates. We assessed quality with Cochrane Risk of Bias Tool-2, Newcastle-Ottawa Scale and Quality Assessment of Diagnostic Accuracy Studies-2 tool., Results: We summarised results from 45 studies reporting self-sampling alone (73.3%; 33 of 45) or combined with digital innovations (26.7%; 12 of 45) conducted in 10 high-income (HICs; n=34) and 8 low/middle-income countries (LMICs; n=11). 95.6% (43 of 45) were observational, while 4.4% (2 of 45) were randomised clinical trials.We noted that pooled sensitivity (n=13) for CT/GC was higher in extragenital self-sampling (>91.6% (86.0%-95.1%)) than in vaginal self-sampling (79.6% (62.1%-90.3%)), while pooled specificity remained high (>99.0% (98.2%-99.5%)).Participants found self-sampling highly acceptable (80.0%-100.0%; n=24), but preference varied (23.1%-83.0%; n=16).Self-sampling reached 51.0%-70.0% (n=3) of first-time testers and resulted in 89.0%-100.0% (n=3) linkages to care. Digital innovations led to 65.0%-92% engagement and 43.8%-57.1% kit return rates (n=3).Quality of studies varied., Discussion: Self-sampling had mixed sensitivity, reached first-time testers and was accepted with high linkages to care. We recommend self-sampling for CT/GC in HICs but additional evaluations in LMICs. Digital innovations impacted engagement and may reduce disease burden in hard-to-reach populations., Prospero Registration Number: CRD42021262950., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Pre-exposure prophylaxis (PrEP) users are routinely tested four times a year (3 monthly) for asymptomatic Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections on three anatomical locations. Given the high costs of this testing to the PrEP programme, we assessed the impact of 3 monthly screening(current practice), compared with 6 monthly on the disease burden. We quantified the difference in impact of these two testing frequencies on the prevalence of CT and NG among all men who have sex with men (MSM) who are at risk of an STI, and explored the cost-effectiveness of 3-monthly screening compared with a baseline scenario of 6-monthly screening., Methods: A dynamic infection model was developed to simulate the transmission of CT and NG among sexually active MSM (6500 MSM on PrEP and 29 531 MSM not on PrEP), and the impact of two different test frequencies over a 10-year period. The difference in number of averted infections was used to calculate incremental costs and quality-adjusted life-years (QALY) as well as an incremental cost-effectiveness ratio (ICER) from a societal perspective., Results: Compared with 6-monthly screening, 3-monthly screening of PrEP users for CT and NG cost an additional €46.8 million over a period of 10 years. Both screening frequencies would significantly reduce the prevalence of CT and NG, but 3-monthly screening would avert and extra ~18 250 CT and NG infections compared with 6-monthly screening, resulting in a gain of ~81 QALYs. The corresponding ICER was ~€430 000 per QALY gained, which exceeded the cost-effectiveness threshold of €20 000 per QALY., Conclusions: Three-monthly screening for CT and NG among MSM on PrEP is not cost-effective compared with 6-monthly screening. The ICER becomes more favourable when a smaller fraction of all MSM at risk for an STI are screened. Reducing the screening frequency could be considered when the PrEP programme is established and the prevalence of CT and NG decline., Competing Interests: Competing interests: EH obtained advisory board fees and a research grant from Gilead Sciences; both of which were paid to her institute., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Sexually Transmitted Infections, including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem. Increased access to point-of-care-tests (POCTs) could help detect infection and lead to appropriate management of cases and contacts, reducing transmission and development of reproductive health sequelae. Yet diagnostics with good clinical effectiveness evidence can fail to be implemented into routine care. Here we assess values beyond clinical effectiveness for molecular CT/NG POCTs implemented across diverse routine practice settings., Methods: We conducted a systematic review of peer-reviewed primary research and conference abstract publications in Medline and Embase reporting on molecular CT/NG POCT implementation in routine clinical practice until 16th February 2021. Results were extracted into EndNote software and initially screened by title and abstract by one author according to the inclusion and exclusion criteria. Articles that met the criteria, or were unclear, were included for full-text assessment by all authors. Results were synthesised to assess the tests against guidance criteria and develop a CT/NG POCT value proposition for multiple stakeholders and settings., Findings: The systematic review search returned 440 articles; 28 were included overall. The Cepheid CT/NG GeneXpert was the only molecular CT/NG POCT implemented and evaluated in routine practice. It did not fulfil all test guidance criteria, however, studies of test implementation showed multiple values for test use across various healthcare settings and locations. Our value proposition highlights that the majority of values are setting-specific. Sexual health services and outreach services have the least overlap, with General Practice and other non-sexual health specialist services serving as a "bridge" between the two., Conclusions: Those wishing to improve CT/NG diagnosis should be supported to identify the values most relevant to their settings and context, and prioritise implementation of tests that are most closely aligned with those values., Competing Interests: We have read the journal’s policy and the authors of this manuscript have the following competing interests: ADREU has received funding from Abbott, binx health, Cepheid, SpeedDx, Mologic, Revolugen and Sekisui, for the research and evaluation of their diagnostics. SSF was a co-investigator on Innovate UK grant to binx health, "A stratified medicine diagnostic test for STI patients at the point-of-care" (ref: 971543) and is a consultant for the WHO on point-of-care tests for sexually transmitted infections. EHE and EC report that no competing interests exist. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

The new Abbott Alinity m STI Assay was compared with Abbott m2000 RealTime PCR. For Chlamydia trachomatis, 26 (7.5%) of 347 samples were positive in the Alinity assay and 24 (6.9%) in the m2000 assay. Corresponding figures for Neisseria gonorrhoeae were 23 (6.6%) and 17 (4.9%). For Mycoplasma genitalium, 22 (7.9%) of 279 samples were positive in the Alinity assay and 18 (6.5%) in the m2000 assay, for which DNA extraction was performed on an m2000sp instrument combined with in-house real-time PCR. The Alinity assay has at least the same sensitivity as the m2000 assay. The specificity was evaluated by discrepancy analysis., (© 2020. The Author(s).)

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., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Jeffrey D. Klausner and Claire C. Bristow have received donated research supplies and consulting fees from Cepheid.

Introduction: Provider-collected swabs are an unappealing procedure for many transgender women and may have led to suboptimal rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing. Self-collection for CT/NG testing is recommended for men who have sex with men. However, the information on acceptability and clinical performance to support a recommendation for transgender women is lacking. We aimed to determine the acceptability and satisfaction towards self-collection for CT/NG testing among Thai transgender women., Methods: Thai transgender women who attended Tangerine Clinic (a transgender-led, integrated, gender-affirming care and sexual health services clinic in Bangkok, Thailand) between May and July 2020 and had condomless sexual intercourse within the past six months were offered to collect urine and perform self-swabs of pharyngeal, rectal, and if applicable, neovaginal compartments for pooled nucleic acid amplification testing for CT/NG infections. Participants received a diagram, video and oral instructions about how to perform self-collection procedure. Those who accepted self-collection were also offered to receive provider collection to evaluate the performance between the two methods. Self-administered questionnaires were used to assess satisfaction., Results: Among 216 transgender women enrolled, 142 (65.7%) accepted self-collection. All who accepted had pharyngeal, rectal and urine samples collected. Of 31 transgender women who had undergone genital surgery, 28 (90.3%) accepted neovaginal self-swab. The acceptance rate increased from 46.2% in May to 84.5% in July 2020. One participant had an invalid result. All transgender women who accepted self-collection could perform it without assistance, and 82.8% were highly satisfied with the method. None reported dissatisfaction. Due to the COVID-19 pandemic, provider collection services were discontinued early, and only eight transgender women were able to perform both methods for performance evaluation. The performance agreement was 100%., Conclusions: Thai transgender women had high acceptability and satisfaction towards self-collection for CT/NG testing. The performance was promising compared to provider collection. Our results support the implementation of self-collection to the sexually transmitted infection services, particularly during the COVID-19 pandemic where physical distancing is the new normal. A larger study is warranted to determine the performance of self-collection for CT/NG testing in each anatomical compartment and confirm the performance between self-collection and provider collection., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Pelvic inflammatory disease (PID) results from ascension of sexually transmitted pathogens from the lower genital tract to the uterus and/or fallopian tubes in women, with potential spread to neighboring pelvic organs. Patients may present acutely with lower abdominal or pelvic pain and pelvic organ tenderness. Many have subtle symptoms or are asymptomatic and present later with tubal factor infertility, ectopic pregnancy, or chronic pelvic pain. Neisseria gonorrhoeae and Chlamydia trachomatis are the 2 most commonly recognized PID pathogens. Their ability to survive within host epithelial cells and neutrophils highlights a need for T-cell-mediated production of interferon γ in protection. Data indicate that for both pathogens, antibody can accelerate clearance by enhancing opsonophagocytosis and bacterial killing when interferon γ is present. A study of women with N. gonorrhoeae- and/or C. trachomatis-induced PID with histologic endometritis revealed activation of myeloid cell, cell death, and innate inflammatory pathways in conjunction with dampening of T-cell activation pathways. These findings are supported by multiple studies in mouse models of monoinfection with N. gonorrhoeae or Chlamydia spp. Both pathogens exert multiple mechanisms of immune evasion that benefit themselves and each other at the expense of the host. However, similarities in host immune mechanisms that defend against these 2 bacterial pathogens instill optimism for the prospects of a combined vaccine for prevention of PID and infections in both women and men., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Objectives: To assess whether pooled sample testing with nucleic acid amplification tests was a potential alternative to three single-site sample testing to screen for Chlamydia trachomatis and Neisseria gonorrhoeae infections in asymptomatic men who have sex with men., Methods: We prospectively compared pooled sample testing with single-site sample testing in asymptomatic MSM. Self-obtained paired rectal samples, one gargle sample and one first-void urine sample were collected from participants to generate two sets of samples: one for pooled sample testing and the other for single-site testing. We used modified pooled sampling, which is defined as the use of gargle samples, instead of swabs, for the pooled sample to test for pharyngeal infection., Results: This study included 513 MSM. The positive rates of C. trachomatis and N. gonorrhoeae were 20.3% and 11.7%, respectively, for single-site sample testing. Compared with the sensitivity of single-site testing as the gold standard, the sensitivities of pooled sample testing for C. trachomatis and N. gonorrhoeae were 94.2% (95% CI 88.0% to 97.3%) and 98.3% (95% CI 90.9% to 99.9%), respectively. The concordance rate and kappa coefficient were 98.3% (95% CI 96.7% to 99.2%) and 0.945 (95% CI 0.859 to 1.000), respectively, for C. trachomatis and 98.8% (95% CI 90.1% to 100%) and 0.943 (95% CI 0.857 to 1.000), respectively, for N. gonorrhoeae ., Conclusions: The modified pooled sampling had a comparably high consistency with single-site sample testing. The results strongly suggest that the gargle sample is suitable as a part of pooled sample for STI screening of C. trachomatis and N. gonorrhoeae ., Competing Interests: Competing interests: SO has received research grants/materials from Gilead Sciences, MSD KK, CSL Behring and ViiV Healthcare, Co., and has received honorarium for lectures from MSD KK, Gilead Sciences, ViiV Healthcare and Janssen Pharmaceutical, KK., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Antenatal screening for HIV, syphilis and HBV has been successfully implemented in The Netherlands, but data on other STI among pregnant women or male partners are limited. Our objectives: (i) to assess the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) among pregnant women and male partners, (ii) to identify risk factors for these STI during pregnancy, and (iii) to identify adverse perinatal outcomes (APO) associated with STI., Methods: Cross-sectional study. Pregnant women aged ≤ 30 years (n = 548) and male partners (n = 425) were included at 30 midwifery practices during 2012-2016. Participants provided a self-collected vaginal swab (women) or urine sample (men) and completed a questionnaire. Perinatal data were derived from pregnancy cards. APO was defined as premature rupture of membranes, preterm delivery, low birthweight, stillbirth, neonatal conjunctival and respiratory infections. Data were analysed by logistic regression., Results: STI were present in 2.4% of pregnant women (CT 1.8%, NG 0.4%, TV 0.4%), and in 2.2% of male partners (CT 2.2%, NG 0.2%, TV 0%). Of young women (≤ 20 years), 12.5% had a CT infection. Prevalent STI during pregnancy was associated with female young age (≤ 20 years vs ≥ 21 years) (adjusted OR 6.52, CI 95%: 1.11-38.33), male non-Western vs Western background (aOR 9.34, CI 2.34-37.21), and female with ≥ 2 sex partners < 12 months vs 0-1 (aOR 9.88, CI 2.08-46.91). APO was not associated with STI, but was associated with female low education (aOR 3.36, CI 1.12-10.09), complications with previous newborn (aOR 10.49, CI 3.21-34.25 vs no complications) and short duration (0-4 years) of relationship (aOR 2.75, CI 1.41-5.39 vs ≥ 5 years). Small-for-gestational-age was not associated with STI, but was associated with female low education (aOR 7.81, 2.01-30.27), female non-Western background (aOR 4.41, 1.74-11.17), and both parents smoking during pregnancy (aOR 2.94, 1.01-8.84 vs both non-smoking)., Conclusions: Prevalence of STI was low among pregnant women and male partners in midwifery practices, except for CT among young women. The study could not confirm previously observed associations between STI and APO, which is probably due to low prevalence of STI, small study sample, and presumed treatment for STI.

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 Q x Amplified DNA Assay and BD ProbeTec Trichomonas vaginalis Q x 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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Recommendations for sexually transmitted infection (STI) screening vary significantly across countries. This study evaluated the prevalence of urogenital and extragenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) in patients visiting a French STI clinic in the Indian Ocean region to determine whether current STI screening practices should be updated., Methods: This cross-sectional study examined all patients who visited the STI clinic between 2014 and 2015. Triplex polymerase chain reaction screening for CT, NG, and MG was performed on urine, vaginal, pharyngeal, and anal specimens (FTD Urethritis Basic Kit, Fast Track Diagnostics, Luxembourg)., Results: Of the 851 patients enrolled in the study, 367 were women (367/851, 43.2%) and 484 were men (484/851, 56.0%). Overall, 826 urogenital specimens (826/851, 97.1%), 606 pharyngeal specimens (606/851, 71.2%), and 127 anal specimens (127/851, 14.9%) were taken from enrolled patients. The prevalence of urogenital CT and MG was high in women ≤25 years (19/186, 10.21%; 5/186, 2.69%) and in men who have sex with women ≤30 years (16/212, 7.54%; 5/212, 2.36%). Among patients with urogenital CT infection, 13.7% (7/51) had urethritis. All patients with urogenital MG infection were asymptomatic. Men who have sex with men had a high prevalence of pharyngeal CT (2/45, 4.44%) and NG (3/44, 6.81%) and a high prevalence of anal CT (2/27, 7.41%), NG (2/27, 7.40%), and MG (1/27, 3.70%). After excluding patients with concomitant urogenital infection, extragenital infections with at least 1 of the 3 pathogens were found in 20 swabs (20/91, 21.9%) taken from 16 patients (16/81, 19.7%), all of them asymptomatic., Conclusions: Routine multisite screening for CT, NG, and MG should be performed to mitigate the transmission of STIs in high-risk sexually active populations.

We developed a rapid multiplex PCR assay available in bedside for the simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis, which enables diagnosis in less than 30 minutes. In this study, we validated the clinical utility of this assay including its sensitivity and specificity for NG and CT detection., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Neisseria gonorrhoeae , Chlamydia trachomatis and Trichomonas vaginalis infections are a public health concern and cost the United States' healthcare system 16 billion dollars annually. By minimizing barriers to testing, an increased number of infections can be detected and treated. A home-based point-of-care (POC) sexually transmitted infection (STI) test may reduce personal, structural, social and system-level barriers to STI testing. This study assesses patient preferences and acceptance of home-based POC STI testing. We performed a cross-sectional, single-visit study of women aged 18 years and older at a single site. Women completed an anonymous online survey evaluating interest in POC STI testing, comfort in self-collecting vaginal swabs and participant reaction to a positive STI result. 138 participants completed the anonymous online survey. The survey results indicate high acceptability with self-collection of samples and home POC STI testing. A majority of participants were interested or very interested in a home POC STI device-especially amongst women with a past history of a STI. If receiving a positive test result, participants indicated they would want to have someone to discuss their results with, most preferring to speak with their primary care provider. Women on lower incomes were less comfortable and less interested with home testing. Women are likely to be receptive to home POC STI testing. Adapting to home-based testing will require engagement of primary care providers for management and surveillance of STIs.

Background: This study's purposes were to characterize detection rates of several sexually transmitted infection (STI) agents and describe the effect additional specimen source and analyte screening has on STI detection within a cohort of young men who have sex with men and transgender women., Methods: Within a 16-month interval, 1966 encounters involved dual urine and rectal swab submissions assessed by commercial transcription-mediated amplification-based assays for Chlamydia trachomatis and Neisseria gonorrhoeae and by off-label transcription-mediated amplification-based Trichomonas vaginalis and Mycoplasma genitalium testing. Identification of STI carriers used algorithms involving Food and Drug Administration-cleared screening methods, laboratory-modified testing for extraurogenital C. trachomatis and N. gonorrhoeae, and laboratory-developed tests for T. vaginalis and M. genitalium., Results: Food and Drug Administration-indicated urine C. trachomatis and N. gonorrhoeae screening revealed 39 encounters (2.0%) yielding one or both agents. Via C. trachomatis and N. gonorrhoeae screening that included rectal swab analysis, 264 encounters (13.4%) yielded evidence of either (140 C. trachomatis, 88 N. gonorrhoeae) or both (36 participants) infections. Detection rates for C. trachomatis and N. gonorrhoeae were 1.4% and 0.6% for urine screening and 8.2% and 6.2% for rectal screening, respectively. Off-label screening identified 413 additional encounters with STI (5 T. vaginalis, 396 M. genitalium, 12 with both). Of these identifications, 82.1% were generated from analysis of rectal swabs (4 participants with T. vaginalis, 323 participants with M. genitalium, 12 with both). Overall detection rates of T. vaginalis (0.2% urine, 1.3% rectal) and M. genitalium (9.1% urine, 21.5% rectal) were variable., Conclusions: Additive analyte testing, including extraurogenital collections, contributes to comprehensive STI screening within a high-risk demographic.

Background: Nucleic acid amplification tests (NAATs) are being used increasing to detection of CT (Chlamydia trachomatis) and NG (Neisseria gonorrhoeae) infections for superior sensitivity and specificity than other tests. Male first-void urine (FVU) sample is the optimal sample type for detection of CT and NG by NAATs. Although not being the recommended by NAATs, clinician-collected urethra swab (CCUS) is perhaps a good alternative sample type compared with the FVU sample in men., Methods: Paired samples (FVU and CCUS) from one hundred male outpatients were simultaneously detected by urine pattern and swab pattern using cobas 4800 CT/NG assay on cobas 4800 system for the detection of CT and NG, respectively. And twenty-one positive controls were also detected on cobas 4800 system., Results: The CT/NG cycle thresholds (Ct) value of urine pattern is lower than that of swab pattern for the same positive samples (clinical samples and positive controls) on the cobas 4800 CT/NG assay. The final CT/NG results of two sample patterns from patients were highly consistent except for four discordant results., Conclusion: CCUS is validated for a good alternative sample type for the CT/NG detection on the cobas 4800 system in this study., (© 2020 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals Inc.)

The present study investigates the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) among women with genitourinary infection and pregnancy-related complications in Tehran. It also evaluates the demographic information, symptoms, and sequelae. Endocervical samples were obtained over a period of eight months from 360 women including 180 symptomatic patients and 180 patients with pregnancy-related complications and infertility. CT, NG, and TV were detected in 10.8%, 6.9%, and 8.3% of all patients, respectively. The prevalence of CT, NG, and TV among women in the symptomatic group was 11.1%, 7.2%, and 13.3%, respectively, and among women with pregnancy-related complications and infertility was 10.6%, 6.7%, and 3.3%, respectively. Associations between chlamydia and ectopic pregnancy ( p  =   0.001), and infertility ( p  <   0.001) were observed. Abortion ( p  =   0.008), infertility ( p  =   0.005), and ectopic pregnancy ( p  <   0.001) were associated with gonorrhea. Abnormal vaginal discharge ( p  =   0.02) and vulvar itching ( p  =   0.02) were associated with trichomoniasis. Overall, the prevalence rates of CT, NG, and TV were high in these patient groups. These high prevalences suggest that screening programs are required to reduce the burden of these sexually transmitted infections and their effects on genitourinary symptoms, pregnancy-related complications, and infertility.

Background: Extragenital gonorrhea (GC) and chlamydia (CT) are usually asymptomatic and only detected through screening. Ceftriaxone plus azithromycin is the recommended GC treatment; monotherapy (azithromycin or doxycycline) is recommended for CT. In urethral CT-positive/urethral GC-negative persons who are not screened extragenitally, CT monotherapy can lead to GC undertreatment and may foster the development of gonococcal antimicrobial resistance. We assessed urethral and extragenital GC and CT positivity among men who have sex with men (MSM) attending sexually transmitted disease clinics., Methods: We included visit data for MSM tested for GC and CT at 30 sexually transmitted disease clinics in 10 jurisdictions during January 1, 2015, and June 30, 2019. Using an inverse-variance random effects model to account for heterogeneity between jurisdictions, we calculated weighted test visit positivity estimates and 95% confidence intervals (CI) for GC and CT at urethral and extragenital sites, and extragenital GC among urethral CT-positive/GC-negative test visits., Results: Of 139,718 GC and CT test visits, we calculated overall positivity (GC, 16.7% [95% CI, 14.4-19.1]; CT, 13.3% [95% CI, 12.7-13.9]); urethral positivity (GC, 7.5% [95% CI, 5.7-9.3]; CT, 5.2% [95% CI, 4.6-5.8]); rectal positivity (GC, 11.8% [95% CI, 10.4-13.2]; CT, 12.6% [95% CI, 11.8-13.4]); and pharyngeal positivity (GC, 9.1% [95% CI, 7.9-10.3]; CT, 1.8% [95% CI, 1.6-2.0]). Of 4566 urethral CT-positive/GC-negative test visits with extragenital testing, extragenital GC positivity was 12.5% (95% CI, 10.9-14.1)., Conclusions: Extragenital GC and CT were common among MSM. Without extragenital screening of MSM with urethral CT, extragenital GC would have been undetected and undertreated in approximately 13% of these men. Undertreatment could potentially select for antimicrobial resistance. These findings underscore the importance of extragenital screening in MSM.

Background: Rectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are increasingly recognized as common infections among women. Little is known about the prevalence of rectal Mycoplasma genitalium (MG), rectal MG/CT/GC coinfection, or MG antimicrobial resistance patterns among women., Methods: In 2017 to 2018, we recruited women at high risk for CT from Seattle's municipal sexually transmitted disease clinic. Participants self-collected vaginal and rectal specimens for CT/GC nucleic acid amplification testing. We retrospectively tested samples for vaginal and rectal MG using nucleic acid amplification testing and tested MG-positive specimens for macrolide resistance-mediating mutations (MRM) and ParC quinolone resistance-associated mutations (QRAMs)., Results: Of 50 enrolled women, 13 (26%) tested positive for MG, including 10 (20%) with vaginal MG and 11 (22%) with rectal MG; 8 (62%) had concurrent vaginal/rectal MG. Five (38%) were coinfected with CT, none with GC. Only 2 of 11 women with rectal MG reported anal sex in the prior year. Of MG-positive specimens, 100% of rectal and 89% of vaginal specimens had an MRM. There were no vaginal or rectal MG-positive specimens with ParC QRAMs previously associated with quinolone failure. Five MG-infected women received azithromycin for vaginal CT, 4 of whom had a MG MRM detected in their vaginal and/or rectal specimens., Conclusions: We observed a high prevalence of macrolide-resistant vaginal and rectal MG among a population of women at high risk for CT. This study highlights how the use of antimicrobials designed to treat an identified infection-in this case, CT-could influence treatment outcomes and antimicrobial susceptibility in other unidentified infections.

Simultaneous multiple gene detection is indispensable for the detection of various genes in a small sample obtained by an invasive method. A typical detection method is probe-based fluorescence melting curve analysis by means of real-time PCR. It is very limited because, for each target, a probe sequence with at least a different T m must be designed. To overcome this limitation, we developed a simultaneous multiple gene detection method based on a giant amplicon molecular beacon. PCR was performed by attaching stem sequences with different T m values to each primer set, and the melting T m was measured by hybridizing the stem sequences at both ends of the amplified amplicon; this generated well-separated T m signals. The important point here is that the stem sequence that produces the T m signal is an arbitrarily selectable sequence unrelated to the target gene. Because it is arbitrarily selectable, the desired T m can be freely adjusted. As a result, we succeeded in the simultaneous detection of four samples with the use of only one fluorophore. Theoretically, a combination of five fluorophores could detect more than 20 multiple genes simultaneously., (© 2019 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Urogenital and rectal specimens collected from the "IWantTheKit" Internet-based sexually transmitted infection screening program were evaluated for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Of 881 paired specimens submitted from August 2013 to December 2016, 15.0% (n = 132) tested positive for 1 or more sexually transmitted infections, of which 50.8% (n = 67) were identified exclusively through rectal testing.

Background: Men who have sex with men (MSM) are disproportionally affected by sexually transmitted infections (STI). STI are often extragenital and asymptomatic. Both can delay diagnosis and treatment. Approval of HIV pre-exposure prophylaxis (PrEP) might have influenced sexual behaviour and STI-prevalence of HIV- MSM. We estimated STI-prevalence and risk factors amongst HIV- and HIV+ MSM in Germany to plan effective interventions., Methods: We conducted a nationwide, cross-sectional study between February and July 2018. Thirteen MSM-friendly STI-practices screened MSM for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Neisseria gonorrhea (NG), and Trichomonas vaginalis (TV) using self-collected rectal and pharyngeal swabs, and urine samples. APTIMA™ STI-assays (Hologic™ Inc., San Diego, USA) were used for diagnostics, and samples were not pooled. We collected information on socio-demographics, HIV-status, clinical symptoms, sexual behaviour within the last 6 months, and PrEP use. We combined HIV status and PrEP use for defining risk groups, and used directed acyclic graphs and multivariable logistic regression to identify risk factors for STI., Results: Two thousand three hundred three MSM were included: 50.5% HIV+, median age 39 [18-79] years. Median number of male sex partners within the last 6 months was five. Sex without condom was reported by 73.6%, use of party drugs by 44.6%. 80.3% had a STI history, 32.2% of STI+ MSM reported STI-related symptoms. 27.6% of HIV- MSM used PrEP. Overall STI-prevalence was 30.1, 25.0% in HIV-/PrEP- MSM (CT:7.2%; MG:14.2%; NG:7.4%; TV:0%), 40.3% in HIV-/PrEP+ MSM (CT:13.8%; MG:19.4%; NG:14.8%; TV:0.4%), and 30.8% in HIV+ MSM (CT:10.1%; MG:18.4%; NG:8.6%; TV:0.1%). Being HIV+ (OR 1.7, 95%-CI 1.3-2.2), using PrEP (OR 2.0, 95%-CI 1.5-2.7), having > 5 sex partners (OR:1.65; 95%-CI:1.32-2.01.9), having condomless sex (OR:2.11.9; 95%-CI:1.65-2.86), and using party drugs (OR:1.65; 95%-CI:1.32-2.0) were independent risk factors for being tested positive for at least one STI., Conclusions: We found a high STI-prevalence in MSM in Germany, especially in PrEP users, frequently being asymptomatic. As a relevant proportion of PrEP users will not use a condom, counselling and comprehensive STI screening is essential and should be low threshold and preferably free of cost. Counselling of PrEP users should also address use of party drugs.

Introduction: Bacterial sexually transmitted infections (STIs) have an important impact on reproductive health, highlighting the increase in Chlamydia trachomatis infection rates among young people. To reduce the costs of STI detection, the pooling strategy is beneficial for high-throughput tests in low-prevalence populations using non-invasive samples., Objectives: (1) To describe the performance of a 7-STI PCR assay using the pooling of three urine samples to detect C. trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium; (2) to estimate the cost saving of the pooling strategy; (3) to describe the prevalence, risk factors and coinfections of C. trachomatis, N. gonorrhoeae and M. genitalium in young people ≤25 years in Catalonia., Methods: cross-sectional prevalence study conducted in 2016 among young people ≤25 years of age seen in sexual and reproductive health centres throughout Catalonia from pools of three urine samples. A standardized questionnaire was used to collect clinical-epidemiological and behavioural variables., Results: 1032 young people were tested. The prevalence of C. trachomatis, N. gonorrhoeae and M. genitalium was 8.5%, 0.6% and 3.5%, respectively. The pooling strategy provided a 33% savings in reagent costs., Conclusions: The pooling strategy implemented for epidemiological studies in our context provides a savings that has an impact on the viability of STI detection programmes. In the same way, this study shows that C. trachomatis prevalence continues to increase in this population and, for the first time in Catalonia, the prevalence of M. genitalium in young people is shown., (Copyright © 2019 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.)

Objective: Given rising incidence of Neisseria gonorrhoeae and Chlamydia trachomatis (GC/CT), development of efficacious screening strategies is critical to interruption of the infection cycle. However, a small proportion of nucleic acid amplification testing (NAAT) results are inconclusive-resulting in delays in diagnosis and treatment. As such, this study seeks to evaluate factors associated with inconclusive rectal GC/CT NAAT., Methods: This is a retrospective chart review of individuals who received an inconclusive rectal GC/CT NAAT result at a single institution from 3/2016-6/2018. Inconclusive GC/CT NAAT was defined as presence of PCR amplification inhibitors using Roche Cobas v2.0 CT/NG assay. Clinical charts were abstracted for age, gender, HIV status, GC/CT (urogenital, rectal, pharyngeal) and syphilis screening results during the study period, clinic type (HIV clinic, university student health center, other), and whether repeat testing occurred within 6 months following an inconclusive result. Logistic regression analysis was used to calculate adjusted and unadjusted odds ratios of factors associated with receipt of repeat testing following an inconclusive rectal GC/CT NAAT result., Results: During the study period, 6.1% (852/14,015) of rectal GC/CT NAAT were inconclusive for one or both of GC and CT. Among the 413 patients whose inconclusive rectal GC/CT NAAT results that were included in our analysis, 66.6% (275/413) received repeat testing within 6 months, of which 8.7% (24/275) were positive (compared to 5.4% positivity rate of all rectal samples). In multivariable analysis, individuals living with HIV had lower odds of receiving repeat testing following inconclusive rectal GC/CT NAAT compared to HIV uninfected individuals (adj OR 0.25; p = 0.001)., Conclusions: Despite being disproportionately affected by the STI epidemic, individuals living with HIV had 75% lower odds of receiving repeat testing following inconclusive rectal GC/CT NAAT compared to HIV-uninfected individuals, representing potentially missed opportunities for treatment and prevention of ongoing STI transmission., Competing Interests: The authors have declared that no competing interests exist.

Objectives: The aim of the study was to determine the prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae co-infections among patients with newly diagnosed syphilis., Methods: In patients with any stage of newly diagnosed syphilis swabs were performed from urethra, rectum, pharynx and cervix according to the gender and type of sexual intercourse. From these smears standard validated nucleic acid amplification tests (NAATs) for Chlamydia trachomatis and Neisseria gonorrhoeae infections were done., Results: From 548 (488 men, 60 women) screened patients co-infection was detected in 15.9% of the cases. The majority of the co-infections (86.2%) were asymptomatic. The overall prevalence of chlamydial infection was 11.1% and 8.8% for gonococcal infections. In men who have sex with men (MSM) the prevalence of co-infections was significantly higher (20.0%) than in heterosexual men and women (4.2%) (p < 0.001). In MSM patients the presence of co-infection was significantly associated with HIV infection (p < 0.001). Among MSM 9.6% of the tests detected infection in anorectal site, while prevalence in urethral (2.8%) and pharyngeal (2.4%) localization was significantly lower. In heterosexual patients prevalence was less than 2.0% in all anatomic sites., Conclusions: The implementation of screening tests in case of sexually transmitted infections in patients with newly diagnosed syphilis is an important part in the management of this disease. These results suggest that screening of asymptomatic heterosexual patients leads to detection of minimum co-infections, but in MSM (especially HIV positive) should always be performed at least in anorectal site, where asymptomatic co-infections are common.