Extragenital Neisseria Gonorrhoeae Research Articles

Testing for extragenital Neisseria gonorrhoeae and Chlamydia trachomatis: At-home pharyngeal and rectal self-swabs are non-inferior to those completed in healthcare settings.

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. To evaluate the performance of at-home self-collected pharyngeal and rectal swabs for gonorrhea and chlamydia nucleic acid amplification testing. 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. 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). Self-collected at-home swabs had good performance acceptable for gonorrhea and chlamydia nucleic acid amplification testing.

Antimicrobial Susceptibility of Urogenital and Extragenital Neisseria gonorrhoeae Isolates Among Men Who Have Sex With Men: Strengthening the US Response to Resistant Gonorrhea and Enhanced Gonococcal Isolate Surveillance Project, 2018 to 2019.

We investigated differences in gonococcal antimicrobial susceptibility by anatomic site among cisgender men who have sex with men (MSM) using specimens collected through the Centers for Disease Control and Prevention's enhanced Gonococcal Isolate Surveillance Project and Strengthening the US Response to Resistant Gonorrhea. During the period January 1, 2018-December 31, 2019, 12 enhanced Gonococcal Isolate Surveillance Project and 8 Strengthening the US Response to Resistant Gonorrhea sites collected urogenital, pharyngeal, and rectal isolates from cisgender MSM in sexually transmitted disease clinics. Gonococcal isolates were sent to regional laboratories for antimicrobial susceptibility testing by agar dilution. To account for correlated observations, linear mixed-effects models were used to calculate geometric mean minimum inhibitory concentrations (MICs), and mixed-effects logistic regression models were used to calculate the proportion of isolates with elevated or resistant MICs; comparisons were made across anatomic sites. Participating clinics collected 3974 urethral, 1553 rectal, and 1049 pharyngeal isolates from 5456 unique cisgender MSM. There were no significant differences in the geometric mean MICs for azithromycin, ciprofloxacin, penicillin, and tetracycline by anatomic site. For cefixime and ceftriaxone, geometric mean MICs for pharyngeal isolates were higher compared with anogenital isolates (P < 0.05). The proportion of isolates with elevated ceftriaxone MICs (≥0.125 μg/mL) at the pharynx (0.67%) was higher than at rectal (0.13%) and urethral (0.18%) sites (P < 0.05). Based on data collected from multijurisdictional sentinel surveillance projects, antimicrobial susceptibility patterns of Neisseria gonorrhoeae isolates may differ among MSM at extragenital sites, particularly at the pharynx. Continued investigation into gonococcal susceptibility patterns by anatomic site may be an important strategy to monitor and detect the emergence of antimicrobial resistant gonorrhea over time.

Efficacy of 1 g Ceftriaxone Monotherapy Compared to Dual Therapy With Azithromycin or Doxycycline for Treating Extragenital Gonorrhea Among Men Who Have Sex With Men.

Evidence on efficacy of high-dose ceftriaxone monotherapy for extragenital Neisseria gonorrhoeae (NG) infection is lacking. A cohort of men who have sex with men (MSM) were tested for NG/Chlamydia trachomatis (CT) every 3 months, in a single-center observational study in Tokyo, Japan. MSM aged > 19 years diagnosed with extragenital NG infection between 2017 and 2020 were included. A single dose of 1 g ceftriaxone monotherapy was provided, while dual therapy with a single oral dose of 1 g azithromycin or 100 mg doxycycline administered orally twice daily for 7 days were given, for those coinfected with CT, according to infected sites. Efficacy of these treatments was calculated by the number of NG-negative subjects at test-of-cure divided by the number of subjects treated. Fisher exact tests were used to compare the efficacy between the 2 groups. Of 320 cases diagnosed with extragenital NG, 208 were treated with monotherapy and 112 were treated with dual therapy. The efficacy against total, pharyngeal, and rectal infections was 98.1% (204/208, 95% confidence interval [CI]: 95.2-99.3%), 97.8% (135/138, 95% CI: 93.8-99.4%), and 98.6% (69/70, 95% CI: 92.3-99.9%), respectively, in the monotherapy group, whereas the corresponding efficacy in the dual therapy was 95.5% (107/112, 95% CI: 90.0-98.1%), 96.1% (49/51, 95% CI: 86.8-99.3%), and 95.1% (58/61, 95% CI: 86.5-98.7%), respectively. No significant difference in the corresponding efficacy was observed between the two groups (P = .29, P = .61, P = .34, respectively). High-dose ceftriaxone monotherapy is as effective as dual therapy for extragenital NG among MSM.

Swab-Yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 2. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Rectal, Pharyngeal, and Urogenital Samples Analyzed Individually, Versus as a Pooled Specimen, for the Diagnosis of Gonorrhea and Chlamydia.

Sexual history does not accurately identify those with extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), so universal extragenital sampling is recommended. Nucleic acid amplification tests (NAATs) are expensive. If urogenital, plus rectal and pharyngeal, samples are analyzed, the diagnostic cost is trebled. Pooling samples into 1 NAAT container would cost the same as urogenital samples alone. We compared clinician triple samples analyzed individually with self-taken pooled samples for diagnostic accuracy, and cost, in men who have sex with men (MSM) and females. This was a prospective, convenience sample in United Kingdom sexual health clinic. Randomized order of clinician and self-samples from pharynx, rectum, plus first-catch urine (FCU) in MSM and vulvovaginal swabs (VVS) in females, for NG and CT detection. Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx); 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx). There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1% and 98.3%), but clinician samples analyzed individually identified 3% more chlamydia infections than pooled (99.3% and 96.0%; P = .027). However, pooled specimens identified more infections than VVS/FCU alone. Pooled specimens missed 2 NG and 11 CT infections, whereas VVS/FCU missed 41 NG and 58 CT infections. Self-taken pooled specimens were the most cost-effective. FCU/VVS testing alone missed many infections. Self-taken pooled samples were as sensitive as clinician triple samples for identifying NG, but clinician samples analyzed individually identified 3% more CT infections than pooled. The extragenital sampling was achievable at no additional diagnostic cost to the FCU/VVS. NCT02371109.

Swab-yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 1. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Clinician-taken vs Self-taken Rectal and Pharyngeal Samples for the Diagnosis of Gonorrhea and Chlamydia.

Urogenital testing misses extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). Extragenital self-sampling is frequently undertaken despite no robust randomized, controlled trial evidence of efficacy. We compared clinician-taken rectal and pharyngeal samples with self-taken samples for diagnostic accuracy and cost in men who have sex with men (MSM) and in females. This was a prospective convenience sample from a UK sexual health clinic. We randomized the order of clinician- and self-taken samples from the pharynx and rectum, plus first catch urine (MSM) and vulvovaginal swabs (females), for NG/CT detection. Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx); 9.4% infected females and 67.3% MSM were urogenital-negative. A total of 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx); 13.1% infected females and 71.8% MSM were urogenital-negative. Sexual history did not identify those with rectal infections. There was no difference in diagnostic accuracy between clinician- and self-taken samples from the rectum or pharynx. Clinicians took swabs more quickly than participants, so costs were lower. However, in asymptomatic people, nonqualified clinicians would oversee self-swabbing making these costs lower. There was no difference in the diagnostic accuracy of clinician-taken compared with self-taken extragenital samples. Sexual history did not identify those with rectal infections, so individuals should have extragenital clinician- or self-taken samples. Clinician-taken swabs cost less than self-taken swabs; however, in asymptomatic people or those who perform home testing, the costs would be lower than for clinician-taken swabs. NCT02371109.

Performance assessment of the Allplex™ STI Essential real-time PCR assay for the diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis infections in genital and extra-genital sites

Abstract Background Commercial kits performing Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) nucleic acid amplification tests (NAATs) for genital samples are recommended in association with culture, but the majority of real-time polymerase chain reaction (PCR) methods have not received regulatory approval for diagnostics in extra-genital sites. Since 2017, only the Hologic® Aptima Combo2 assay has an in vitro diagnostic (IVD) certification from the European Medicine Evaluation Agency. Methods We assessed the Allplex™ STI-Essential Assay (EA) for the diagnosis of NG and CT in both genital and extra-genital sites. The performance of the extraction step was studied by means of a standard curve between the concentration of expected cultivable gonococci and the cycle threshold (Ct). Three later-generation NAATs were used as comparators, particularly to assess the specificity (Sp). Results A relation between the gonococcal concentration, expressed as colony-forming unit (CFU) per milliliter logarithm, and the Ct was shown to be linear irrespective of the matrices (95% confidence interval [CI]). The detection limit was 10 CFU/mL, contrasting with the relatively poor sensitivity of culture due to inhibitory effects such as pH and the overgrowth of the commensal flora. NG molecular diagnostic is complex and the method comparisons showed some discrepancies when Ct was above 34. We decided to include interpretative comments on our reports on the basis of the Ct result. For CT, comparisons displayed a satisfactory agreement, and the detection limit was 50 copies/mL. Conclusions The Seegene Allplex™ STI-EA showed acceptable performance characteristics for the detection of genital and extra-genital NG and CT.

Genital and Extragenital Gonorrhea and Chlamydia in Children and Adolescents Evaluated for Sexual Abuse.

The aim of this study was to describe the use of a nucleic acid amplification test in detecting genital and extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in children and adolescents assessed for sexual abuse/assault. The charts of children aged 0 to 17 years, consecutively evaluated for sexual victimization, in emergency department and outpatient settings were reviewed. Data extracted included age, sex, type of sexual contact, anogenital findings, previous sexual contact, toxicology results, and sites tested for NG and CT. Of the 1319 patients who were tested, 579 were tested at more than 1 site, and 120 had at least 1 infected site. Chlamydia trachomatis was identified in 104 patients, and NG was found in 33. In bivariate analysis, a positive test was associated with female sex, age older than 11 years, previous sexual contact, acute or healed genital injury, drug/alcohol intoxication, and examination within 72 hours of sexual contact. Fifty-one patients had positive anal tests, and 24 had positive oral tests. More than 75% of patients with positive extragenital tests had additional positive tests or anogenital injury. Most with a positive anal (59%) or oral (77%) test did not report that the assailant's genitals came into contact with that site. Positive tests for NG and CT in patients evaluated for sexual victimization may represent infection from sexual contact, contiguous spread of infection, or the presence of infected assailant secretions. Relying on patient reports of symptoms, or types of sexual contact, to determine need for testing may miss NG and CT infections in patients evaluated for sexual victimization.

Extragenital Gonorrhoea in Men Who Have Sex with Men: A Retrospective Study in a STI Clinic in Lisbon, Portugal.

Recent studies worldwide reveal a significant prevalence of extragenital infections by Neisseria gonorrhoeae amongmen who have sex with men. We aimed to analyse the frequency and characteristics of extragenital gonococcal infections diagnosedin men who have sex with men in a walk-in Sexually Transmitted Infection clinic in Lisbon, Portugal. We conducted a cross-sectional, retrospective study of the anorectal and/or oropharyngeal Neisseriagonorrhoeae infections in men who have sex with men, diagnosed in our Sexually Transmitted Infection clinic between January 2014and December 2016. We found extragenital infection in 87 cases of gonorrhoea identified in men who have sex with men in this period, including:49 cases of anorectal disease, 9 of oropharyngeal disease, 13 cases of infection at both extragenital sites, and 16 of simultaneousextragenital and urogenital gonorrhoea. Patients' ages ranged from 17 to 64 years (median: 28 years). Forty-seven (54%) of thepatients did not present with any extragenital symptoms. Thirty (35%) were human immunodeficiency virus-1-positive. Since most extragenital Neisseria gonorrhoeae infections are asymptomatic, they may be missed and go untreated unlessactively investigated. Current international guidelines recommend the screening of gonorrhoea at extragenital sites in men who havesex with men because anorectal and oropharyngeal infections constitute a potential disease reservoir, and may facilitate transmissionand/or acquisition of human immunodeficiency virus infection. Our results highlight the relevance of testing men who have sex with men for Neisseria gonorrhoeae at extragenitalsites, regardless of the existence of local complaints. The implementation of adequate screening programmes in Portugal should beconsidered. We also reinforce the need to raise awareness in the population regarding the adoption of prophylactic measures againsttransmission of sexually transmitted infections during anal and/or oral sexual exposure.

High incidence of extra-genital gonorrheal and chlamydial infections among high-risk men who have sex with men and transgender women in Peru.

Extra-genital Neisseria gonorrhoeae and Chlamydia trachomatis infections are associated with antimicrobial resistance and HIV acquisition. We analyzed data from a cohort of men who have sex with men (MSM) and transgender women followed quarterly for two years in Peru. Incident cases were defined as positive N. gonorrhoeae or C. trachomatis nucleic acid tests during follow-up. Repeat positive tests were defined as reinfection among those with documented treatment. We used generalized estimating equations to calculate adjusted incidence rate ratios (aIRRs). Of 404 participants, 22% were transgender. Incidence rates of rectal N. gonorrhoeae and C. trachomatis infection were 28.1 and 37.3 cases per 100 person-years, respectively. Incidence rates of pharyngeal N. gonorrhoeae and C. trachomatis infection were 21.3 and 9.6 cases per 100 person-years, respectively. Incident HIV infection was associated with incident rectal (aIRR = 2.43; 95% CI 1.66-3.55) N. gonorrhoeae infection. Identifying as transgender versus cisgender MSM was associated with incident pharyngeal N. gonorrhoeae (aIRR = 1.85; 95% CI 1.12-3.07) infection. The incidence of extra-genital N. gonorrhoeae and C. trachomatis infections was high in our population. The association with incident HIV infection warrants evaluating the impact of rectal N. gonorrhoeae screening and treatment on HIV transmission.

Urine and extragenital gonococcal and Chlamydia infections in HIV positive young men who have sex with men (YMSM): enhanced detection of rectal Chlamydia when screening with nucleic acid amplified tests versus cultures

BackgroundMultiple studies have been done on adult men who have sex with men (MSM), but no studies have shown the rates of extragenital site sexually transmitted infections (STIs) among HIV positive young men who have sex with men (YMSM). The objective of this study was to document the rates of extragenital Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) infection among HIV positive YMSM while conducting a validity study for the use of nucleic acid amplified tests (NAATs), to detect extragenital GC and CT. MethodsBehaviorally infected HIV positive YMSM were enrolled in this study from one urban adolescent HIV clinic, and were screened for urine and extragenital site GC and CT over a 2 year period. Samples from these sites (pharyngeal and rectal) were tested for GC and CT using both traditional culture media and NAAT technology. Urine was tested using only NAAT. ResultsOf 67 screenings, 36% (n=24) yielded at least one positive, and 69% of participants (18/26) had at least one positive GC or CT test result during the study period. Of those with at least one positive result, 89% (16/18) had at least one extragenital site infection. Urine testing was positive in 11% (2/18) of those with a corresponding extragenital site infection. None of the extragenital CT infections detected by NAATs were detected by culture, and only 38% (5/13) of the extragenital GC infections detected by NAATs were detected by culture. ConclusionsUse of NAATs for extragenital STI screening yielded more confirmed positive results than did traditional cultures. By use of NAATs, the majority of routinely screened HIV positive YMSM in this sample was found to have an STI at an extragenital site.