Evaluation of a new CT/NG/TV/MG Real-Time PCR Kit (Vircell) versus the Allplex STI Essential Assay (Seegene) for the diagnosis of sexually transmitted infections.

Sexually transmitted infections (STI) are a public health problem. Real-time PCR assays are the most sensitive test for screening and diagnosis of these infections. The aim of this study was to evaluate a new CT/NG/TV/MG Real-Time PCR (RT-PCR) kit (Vircell) for the detection of Chamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis for the diagnosis of sexual transmitted infections using the Allplex STI Essential Assay (Seegene) as the reference's method. A total of 497 samples from different anatomical sites (endocervical, urethral, rectal, pharyngeal and urine) were analysed from October 2022 to February 2023. A total of 108 (21.73 %) and 106 (21.33 %) positive samples were found for any of the assays used. The most commonly detected pathogen was N. gonorrhoeae (52 samples; 10.46 %), and the least commonly detected was T. vaginalis (three samples; 0.60 %). The anatomical site with the highest prevalence of micro-organisms was a non-urogenital site, the pharynx (26 positive samples; 5.23 %). Using the Allplex STI Essential Assay (Seegene) as the reference method, the diagnosis performance showed that the average specificity of CT/NG/TV/MG RT-PCR Kit (Vircell) was 99.84 % and the sensitivity was 99.53 %. The overall concordance was k=0.98 (CI95 %; 0.96-1). In conclusion, the CT/NG/TV/MG RT-PCR Kit (Vircell) assay shows a good sensitivity and specificity and constitutes a promising and additional alternative to routine procedures for distinct types of clinical specimen in diagnosis STI.

Demographic and clinical characteristics of people diagnosed with active sexually transmitted infections among monkeypox cases in Brazil: the 2022 outbreak.

The worldwide monkeypox (mpox) outbreak in 2022 showed a high frequency of sexually transmitted infections (STI). A cross-sectional study was carried out using secondary data from the Brazilian official mpox surveillance systems. A total of 10,169 mpox cases were identified, with a median age of 32 years. Among them, 92.3% were male at birth and 57.5% were men who have sex with other men (MSM). Approximately 11% were diagnosed with STI, including 5.8% with syphilis and 2.5% with genital herpes. Individuals aged from 25 to 34 years, MSM, individuals with HIV-positive status, and those manifesting skin eruptions or penile edema were associated with STI. Laboratory investigation for mpox must be implemented as a priority in STI clinics (especially for MSM) to mitigate neglected cases, ensure appropriate treatments, and prevent misdiagnoses.

Screening for Chlamydia and Gonorrhea in Youth Correctional Facilities, Utah, USA.

We reviewed data obtained in October 2021-May 2023 from youth who reported a history of sexual activity upon admission to 1 of 12 juvenile justice facilities in Utah, USA, that offered screening for Chlamydia trachomatis and Neisseria gonorrhoeae. Urinalysis revealed C. trachomatis positivity of 10.77%, N. gonorrhoeae positivity of 1.08%, and coinfection C. trachomatis N. gonorrhoeae) of 0.90%. Prevalence of infection was similar for youths in rural and urban facilities. A total of 12.01% of those identifying as male and 14.01% of those identifying as female tested positive for C. trachomatis, N. gonorrhoeae, or coinfection. Of young adults who tested positive, 74.65% received their results while incarcerated, all of whom accepted treatment. Our research underscores the feasibility of providing prompt C. trachomatis/N. gonorrhoeae screening and treatment in juvenile correctional facilities. The pervasiveness of infection emphasizes the urgent need for early identification and treatment for C. trachomatis and N. gonorrhoeae in incarcerated youth nationwide.

Antibiotic overuse, poor antimicrobial stewardship, and low specificity of syndromic case management in a cross section of men with urethral discharge syndrome in Kampala, Uganda.

OBJECTIVE: High prevalence of sexually transmitted infections (STIs) combined with poor antimicrobial stewardship are drivers of STI antimicrobial resistance (AMR) especially in resource-limited settings where syndromic case management (SCM) is the norm. We characterized patterns of antibiotic use prior to clinic attendance and study enrollment in Ugandan men with urethral discharge syndrome (UDS), evaluated in-clinic prescribing, and the performance characteristics of SCM. METHODS: Participants were recruited from government clinics participating in an existing gonococcal surveillance program in Kampala, Uganda. Questionnaires including antimicrobial use prior to attendance, prior episodes of UDS, penile swabs, and blood samples were collected. Bivariable and multivariable logistic regression models were used to estimate odds ratios (OR) for preselected factors likely to be associated with antibiotic use. In-clinic antibiotic treatment data were extracted from clinical notes, and the performance of SCM against laboratory-based STI diagnoses was evaluated. FINDINGS: Between October 2019 and November 2020, 100(40%) of 250 men with UDS reported taking antibiotics in the 14days prior to attending the clinic. Of these 210(84%) had at least one curable STI and 20% had a reactive point-of-care HIV test. Multivariable analysis demonstrated significant associations between recent antimicrobial use and duration of UDS symptoms <6 days (OR 2.98(95%CI 1.07,8.36), p = 0.038), and sex with women only (OR 0.08(95%CI 0.01,0.82),p = 0.038). The sensitivity of SCM ranged from 80.0% to 94.4%; specificity was low between 5.6% and 33.1%. The positive predictive value of SCM ranged from 2.4(95%CI 0.7,6.0) for trichomoniasis to 63.4(95%CI 56.5,69.9) for gonorrhea. CONCLUSION: Pre-enrollment antibiotic use was common in this population at high risk of STI and HIV. Combined with the poor specificity of SCM for male UDS, extensive antibiotic use is a likely driver of STI-AMR in Ugandan men. Interventions to improve antimicrobial stewardship and deliver affordable diagnostics to augment SCM and decrease overtreatment of STI syndromes are required.

Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa.

BACKGROUND: In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening 'women at risk' for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries - Australia, Guatemala, Morocco and South Africa. METHODS: Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs). RESULTS: One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1296 samples for CT/NG and 1380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV. CONCLUSION: This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV. TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee, as well as local ethics committees from all participating countries.

Target enrichment improves culture-independent detection of Neisseria gonorrhoeae and antimicrobial resistance determinants direct from clinical samples with Nanopore sequencing.

Multi-drug-resistant Neisseria gonorrhoeae infection is a significant public health risk. Rapidly detecting N. gonorrhoeae and antimicrobial-resistant (AMR) determinants by metagenomic sequencing of urine is possible, although high levels of host DNA and overgrowth of contaminating species hamper sequencing and limit N. gonorrhoeae genome coverage. We performed Nanopore sequencing of nucleic acid amplification test-positive urine samples and culture-positive urethral swabs with and without probe-based target enrichment, using a custom SureSelect panel, to investigate whether selective enrichment of N. gonorrhoeae DNA improves detection of both species and AMR determinants. Probes were designed to cover the entire N. gonorrhoeae genome, with tenfold enrichment of probes covering selected AMR determinants. Multiplexing was tested in a subset of samples. The proportion of sequence bases classified as N. gonorrhoeae increased in all samples after enrichment, from a median (IQR) of 0.05 % (0.01-0.1 %) to 76 % (42-82 %), giving a corresponding median improvement in fold genome coverage of 365 times (112-720). Over 20-fold coverage, required for robust AMR determinant detection, was achieved in 13/15(87 %) samples, compared to 2/15(13 %) without enrichment. The four samples multiplexed together also achieved >20-fold genome coverage. Coverage of AMR determinants was sufficient to predict resistance conferred by changes in chromosomal genes, where present, and genome coverage also enabled phylogenetic relationships to be reconstructed. Probe-based target enrichment can improve N. gonorrhoeae genome coverage when sequencing DNA extracts directly from urine or urethral swabs, allowing for detection of AMR determinants. Additionally, multiplexing prior to enrichment provided enough genome coverage for AMR detection and reduces the costs associated with this method.

Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in syndromic management settings: a cross-sectional performance evaluation.

BACKGROUND: A rapid and affordable point-of-care test is a priority for Neisseria gonorrhoeae control. WHO and Foundation for Innovative New Diagnostics (FIND) have a target product profile for a non-molecular N gonorrhoeae rapid point-of-care test that requires a clinical sensitivity of greater than 80% and a specificity over 95% to be considered useful in syndromic management; test turnaround time should be 30 min or under, and the test should cost less than US$3. A novel lateral flow assay (LFA) was developed to achieve that profile. METHODS: In this cross-sectional study we evaluated the performance of the novel N gonorrhoeae lateral flow assay (NG-LFA) at the primary health-care level in South Africa. Male patients with urethral discharge syndrome and female patients with vaginal discharge syndrome were recruited from five primary health-care facilities in the Buffalo City Metropolitan Municipality health district of South Africa. First-void urine specimens and nurse-collected vaginal swabs were tested in-facility with the NG-LFA and Xpert CT/NG PCR assay. N gonorrhoeae multi-antigen sequence typing (NG-MAST) was performed on all LFA positive specimens. FINDINGS: Between March 7, and Sept 19, 2022, we enrolled 200 male patients with urethral discharge and 200 female patients with vaginal discharge. The median age of male patients was 24 years (IQR 21-31 years), and the median age of female patients was 25 years (IQR 21-32 years). In addition, 23 male patients and 12 female patients who presented at the facility with a partner notification slip were enrolled of whom one (4%) and five (42%) were symptomatic, respectively. NG-LFA and Xpert results were available for all participants. In urine specimens, NG-LFA sensitivity was 96·1% (Wilson 95% CI 91·2-98·3; 123 LFA-positive among 128 PCR-positive specimens) and 91·7% in vaginal swab specimens (78·2-97·1; 33 LFA-positive among 36 PCR-positive). The specificity was 97·2% in urine specimens (90·4-99·2; 70 LFA-negative among 72 PCR-negative) and 96·3% in vaginal specimens (92·2-98·3; 158 LFA-negative among 164 PCR-negative). In 156 LFA-positive specimens, NG-MAST showed 93 different sequence types. INTERPRETATION: The novel NG-LFA had excellent clinical sensitivity and specificity in symptomatic male and female patients. The test met the optimal requirement for sensitivity and the minimal requirement for specificity specified in the target product profile. NG-LFA could provide an important tool to optimise clinical management and reduce excess antibiotic use in settings without direct access to laboratory testing. FUNDING: Global Antimicrobial Resistance Innovation Fund (GAMRIF) via FIND and National Institutes of Health.

Use of Expedited Partner Therapy for Pregnant Women Treated for Sexually Transmitted Infections in Gaborone, Botswana.

BACKGROUND: Partner notification and treatment for sexually transmitted infections are critical to prevent reinfection and reduce transmission. However, partner treatment rates are low globally. Expedited partner therapy (EPT), in which the patient delivers treatment directly to their partner, may result in more partners treated. We assessed partner notification and treatment outcomes among pregnant women in Gaborone, Botswana, including EPT intent, uptake, and effectiveness. METHODS: The Maduo study was a cluster-controlled trial evaluating the effect of antenatal Chlamydia trachomatis and Neisseria gonorrhoeae infection screening in pregnant women. The intervention arm received screening at first antenatal care (ANC), third-trimester, and postnatal care visits. The standard-of-care arm received screening postnatally. Participants screening positive were given options for partner treatment: contact slips, in-clinic treatment, or EPT. Self-reported partner notification and treatment outcomes were assessed at test-of-cure visit. RESULTS: Of 51 women who screened positive for C. trachomatis / N. gonorrhoeae at first ANC and returned for test of cure, 100% reported notifying their partner and 48 (94.1%) reported their partner received treatment. At third trimester 100% (n = 5), reported partners were treated. Before testing, EPT intent was lower than EPT uptake at all time points (first ANC: 17.9% vs. 80.4%; third-trimester: 57.1% vs. 71.4%; postnatal care: 0% vs. 80.0%). Partner treatment success was 100% among EPT users compared with 70% among nonusers ( P = 0.006). CONCLUSIONS: Partner notification and treatment success was high in this population. Despite low pretest intent to use EPT, uptake was high and associated with greater partner treatment success. Our findings suggest that EPT may be a successful partner treatment strategy to pursue in low- and middle-income countries.

Chlamydial and Gonococcal Infections and Adverse Reproductive Health Conditions Among Patients Assigned Female at Birth in the Veterans Health Administration.

BACKGROUND: Reproductive age female individuals comprise the fastest-growing segment of Veterans Health Administration patients, but little is known about rates of reproductive health outcomes among those with chlamydia or gonorrhea infections. Our aim was to estimate the risk of pelvic inflammatory disease, ectopic pregnancy, infertility, and pelvic pain in female veterans tested for chlamydia or gonorrhea. METHODS: We performed a retrospective cohort analysis of female veterans tested for chlamydia or gonorrhea between January 1, 2010, and December 31, 2020. We calculated rates of pelvic inflammatory disease, ectopic pregnancy, infertility, and pelvic pain per 100,000 person-years and used Cox proportional hazards regression models to estimate the risk of these reproductive health conditions according to infection status after adjustment for age, race, ethnicity, military sexual trauma, mental health diagnoses, and substance use disorder. RESULTS: Of female veterans, 232,614 were tested at least once for chlamydia or gonorrhea, with a total of 1,665,786 person-years of follow-up. Of these, 12,971 had positive chlamydia or gonorrhea results (5.8%, 796 cases per 100,000 person-years). Compared with people who tested negative, those testing positive had double the risk of pelvic inflammatory disease (adjusted hazard ratio [aHR], 1.94; 95% confidence interval [CI], 1.81-2.07), 11% increased risk of infertility (aHR, 1.11; 95% CI, 1.04-1.18), 12% increased risk of pelvic pain (aHR, 1.12; 95% CI, 1.08-1.17), and 21% increased risk of any of these conditions (aHR, 1.21; 95% CI, 1.17-1.25). People with positive chlamydia or gonorrhea testing tended to have an increased risk of ectopic pregnancy (aHR, 1.14; 95% CI, 1.0-1.30). Among those with a positive test result, 2218 people (17.1%) had 1 or more additional positive test results. Compared with those with 1 positive test result, people with more than 1 positive test result had a significantly increased risk of pelvic inflammatory disease (aHR, 1.37; 95% CI, 1.18-1.58), infertility (aHR, 1.20; 95% CI, 1.04-1.39), and pelvic pain (aHR1.16; 95% CI, 1.05-1.28), but not ectopic pregnancy (aHR, 1.09; 95% CI, 0.80-1.47). CONCLUSIONS: Female veterans with positive chlamydia or gonorrhea results experience a significantly higher risk of pelvic inflammatory disease, infertility, and pelvic pain, especially among those with repeat infection.

Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial.

BACKGROUND: Guidelines recommend screening for Neisseria gonorrhoeae and Chlamydia trachomatis at three anatomical sites (urethra, anus, and pharynx) every 3 months (3 × 3) in men who have sex with men (MSM) and transgender women taking HIV pre-exposure prophylaxis (PrEP). We present the first randomised controlled trial to compare the effect of screening versus non-screening for N gonorrhoeae and C trachomatis on the incidence of these infections in MSM and transgender women taking PrEP. METHODS: A multicentre, randomised, controlled trial of 3 × 3 screening for N gonorrhoeae and C trachomatis versus non-screening was done among MSM and transgender women taking PrEP in five HIV reference centers in Belgium. Participants attended the PrEP clinics quarterly for 12 months. N gonorrhoeae and C trachomatis was tested at each visit in both arms, but results were not provided to the non-screening arm, if asymptomatic. The primary outcome was incidence rate of N gonorrhoeae and C trachomatis infections in each arm, assessed in the per-protocol population. Non-inferiority of the non-screening arm was proven if the upper limit of the 95% CI of the incidence rate ratio (IRR) was lower than 1·25. This trial is registered with ClinicalTrials.gov, NCT04269434, and is completed. FINDINGS: Between Sept 21, 2020, and June 4, 2021, 506 participants were randomly assigned to the 3 × 3 screening arm and 508 to the non-screening arm. The overall incidence rate of N gonorrhoeae and C trachomatis was 0·155 cases per 100 person-days (95% CI 0·128-0·186) in the 3 × 3 screening arm and 0·205 (95% CI 0·171-0·246) in the non-screening arm. The incidence rate was significantly higher in the non-screening arm (IRR 1·318, 95% CI 1·068-1·627). Participants in the non-screening arm had a higher incidence of C trachomatis infections and symptomatic C trachomatis infections. There were no significant differences in N gonorrhoeae infections. Participants in the non-screening arm consumed significantly fewer antimicrobial drugs. No serious adverse events were reported. INTERPRETATION: We failed to show that non-screening for N gonorrhoeae and C trachomatis is non-inferior to 3 × 3 screening in MSM and transgender women taking PrEP in Belgium. However, screening was associated with higher antibiotic consumption and had no effect on the incidence of N gonorrhoeae. Further research is needed to assess the benefits and harms of N gonorrhoeae and C trachomatis screening in this population. FUNDING: Belgian Health Care Knowledge Centre.

Analytical and clinical validation of a multiplex PCR assay for detection of Neisseria gonorrhoeae and Chlamydia trachomatis including simultaneous LGV serotyping on an automated high-throughput PCR system.

For effective infection control measures for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), a reliable tool for screening and diagnosis is essential. Here, we aimed to establish and validate a multiplex PCR assay on an automated system using a dual-target approach for the detection of CT/NG and differentiation between lymphogranuloma venereum (LGV) and non-LGV from genital and extra-genital specimens. Published primer/probe sets (CT: pmpH, cryptic plasmid; NG: porA, opa) were modified for the cobas 5800/6800/8800. Standards quantified by digital PCR were used to determine linearity and lower limit of detection (LLoD; eSwab, urine). For clinical validation, prospective samples (n = 319) were compared with a CE-marked in vitro diagnostics (CE-IVD) assay. LLoDs ranged from 21.8 to 244 digital copies (dcp)/mL and 10.8 to 277 dcp/mL in swab and urine, respectively. A simple linear regression analysis yielded slopes ranging from -4.338 to -2.834 and Pearson correlation coefficients from 0.956 to 0.994. Inter- and intra-run variability was <0.5 and <1 cycle threshold (ct), respectively. No cross-reactivity was observed (n = 42). Clinical validation showed a sensitivity of 94.74% (95% confidence interval (CI): 87.23%-97.93%) and 95.51% (95% CI: 89.01%-98.24%), a specificity of 99.59% (95% CI: 97.71%-99.98%) and 99.57% (95% CI: 97.58%-99.98%), positive predictive values of 89.91% (estimated prevalence: 3.7%; 95% CI: 80.91%-95.6%) and 88.61% (estimated prevalence: 3.4%; 95% CI: 80.18%-94.34%), and negative predictive values of 99.81% (95% CI: 98.14%-100%) and 99.85% (95% CI: 98.14%-100%) for the detection of CT and NG, respectively. In conclusion, we established a dual-target, internally controlled PCR on an automated system for the detectiwon of CT/NG from genital and extra-genital specimens. Depending on local regulations, the assay can be used as a screening or a confirmatory/typing assay.IMPORTANCEChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) represent a major global health burden, with the World Health Organization estimating that >128 million and >82 million people, respectively, were newly infected in 2020. For effective infection control measures, a reliable tool for sensitive diagnosis and screening of CT/NG is essential. We established a multiplex PCR assay for the detection of CT/NG and simultaneous discrimination between lymphogranuloma venereum (LGV) and non-LGV strains, which has been validated for genital and extra-genital specimens on a fully automated system. To increase assay sensitivity, a dual-target approach has been chosen for both pathogens. This strategy reduces false-positive results in oropharyngeal swabs due to the detection of commensal N. species that may harbor NG DNA fragments targeted in the PCR due to horizontal gene transmission following previous infection. In sum, the established assay provides a powerful tool for use as either a screening/diagnostic or a typing/confirmatory assay.

Missed opportunities in the early detection of HIV infection in patients with sexually transmitted infections: A real-life study.

INTRODUCTION: Sexually transmitted diseases such as cervicitis, proctitis and urethritis are associated with high rates of HIV infection. When these pathologies are suspected, HIV serology should be requested. MATERIAL AND METHODS: A retrospective study was performed during 2018 at the Hospital Costa del Sol (Marbella, Málaga, Spain). HIV serologies requested in patients who were asked for PCR for Chlamydia trachomatis and Neisseria gonorrhoeae were reviewed. RESULTS: A total of 1818 patients were evaluated, in which HIV serology was performed in 44.7%, of which 14 (1.7%) were positive. The remaining 55.3% were missed diagnostic opportunities. CONCLUSIONS: C. trachomatis and N. gonorrhoeae infections are associated with a high rate of occult HIV infection. The degree of suspicion of HIV in this population remains low and it is essential that it be reinforced in the presence of the possibility of infection by these pathologies.

A Practical Approach to Sexually Transmitted Infection Screening for the Primary Care Clinician.

Sexually transmitted infections (STIs) are commonly encountered in primary care. The Centers for Disease Control and Prevention and the US Preventive Services Task Force have both issued guidelines about screening for chlamydia, gonorrhea, syphilis, and HIV. By eliciting a sexual history, understanding their patients' anatomy, and considering factors which may increase the likelihood of STIs and their sequelae, clinicians can implement a practical, evidence-based approach to STI screening.

Patterns of Chlamydia trachomatis and Neisseria gonorrhoeae in different anatomical sites among Pre-Exposure Prophylaxis (PrEP) users in Brazil.

BACKGROUND: The presence of untreated sexually transmitted infections (STIs) significantly increases the chance of acquiring HIV. In Brazil, testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) among Pre-Exposure Prophylaxis (PrEP) users is insufficient, and syndromic treatment is a priority in clinical practice. Multi-site testing for CT/NG improves thescreening of asymptomatic cases and ensures timely treatment. Therefore, it is essential for HIV prevention. This study aims to test the importance of two-site testing for better screening of these pathogens and to determine whether the presence of symptoms is an indicator of CT/NG infection. METHODS: This is a cross-sectional study carried out in four public infectious diseases clinics in São Paulo State, Brazil between January of 2022 and March of 2023. All participants had an anal swab and a first-pass or mid-stream urine collected for CT/NG analysis by Polymerase chain reaction (PCR). Data about sociodemographic, sexual behavioural and clinical aspects were collected. Pathway analysis was used to examine the direct and indirect relationships between variables according to the theoretical model. RESULTS: We screened 171 PrEP users which had two samples collected, resulting in 342 samples. Comparing the anatomic sites, the urine samples showed lower sensitivity for CT and NG than anal samples. Gonorrhoea was directly linked to lower age (ß= -0.161, p = 0.001). Time of PrEP use was directly associated with CT infection (ß = 0.202; p = 0.042) and inversely associated with dysuria (ß= -0.121, p = 0.009). Lower occurrence of yellow-green secretion was linked to detection of CT (ß= -0.089, p = 0.005) and NG (ß= -0.048, p = 0.002) infections. Foul-smelling discharge was directly associated with CT (ß = 0.275, p = 0.004) and NG (ß = 0.295, p = 0.037) infection. CONCLUSION: The symptoms are a bad indicator of CT and NG infection, and the screening must be done in more than one site since most of the positive results would be missed if only urines were tested. In the case of testing only one anatomical site, specifically the urethra, the CT/NG incidence and prevalence would be underestimated. The two-sites testing improves detection rates of CT/NG, and PrEP follow-up benefits people offering STI testing.

Increasing Incidence of Gonorrhea at an Urban STI Clinic in the United States.

Medical record data was extracted from a sexually transmitted infection (STI) clinic in Providence, Rhode Island to characterize trends in Neisseria gonorrhoeae (GC) infection and explore risk factors. Of 16,601 clinical encounters, 6% (n=991) tested GC positive: 5.28 GC case rate (per 100 encounters) in the first two years of data collection (2015-2016) and 7.04 in the last two years (2020-2021). Analysis suggested a single linear trend line over time (p<.05). Overall, in more recent years, patients were older and more like to identify as male, Black, and Hispanic/Latino, as well as to have reported a previous STI, current symptoms, and specific risk behaviors. GC-positive patients in 2020-2021 were older and more like to identify as female and Black compared to 2015-2016. Lower rates of condom use were especially salient among female patients. These findings may reflect GC trends in the community.

Development of a Novel Fluorescent-Based Lateral Flow Assay for the Detection of Neisseria gonorrhoeae at the Point of Care.

BACKGROUND: Neisseria gonorrhoeae (NG) has acquired significant resistance, primarily due to extensive and unwarranted antibiotic utilization over several decades. This resistance has largely been associated with the syndromic management of sexually transmitted infections, particularly in low- and middle-income countries where affordable point of care tests are unavailable. To address this diagnostic gap, FIND has developed a low-cost lateral flow assay for the detection of NG at the point of care. METHODS: The early performance of the lateral flow assay was evaluated using frozen clinical samples. Limit of detection, inclusivity, and exclusivity studies were performed using well-characterized NG strains, common commensal genital microorganisms, and other Neisseria bacteria. Subsequently, clinical performance was evaluated at 2 sexual health clinics in Birmingham, Alabama. RESULTS: The observed limit of detection with reference NG strains was 5 × 103 CFU/mL. Inclusivity was demonstrated for 31 NG strains. Exclusivity testing showed no cross-reactivity with 28 non-Neisseria and nongonococcal Neisseria species; cross-reactivity was observed with Neisseria meningitidis, Neisseria lactamica, and Neisseria polysaccharea. The lateral flow assay demonstrated clinical sensitivity and specificity of 78.6% and 100% in female vaginal swabs and 100% and 89.7% in male urine, respectively. CONCLUSIONS: FIND has developed a lateral flow assay that aligns with the majority of the World Health Organization Target Product Profile criteria for confirming or excluding NG infection at the point of care. The NG lateral flow assay has now achieved design freeze (final device optimization) and is ready for technology transfer to a manufacturing partner. This test has the potential to support the shift in patient management from a syndromic to an etiological approach.