Barbara Van Der Pol

Gonorrhea treatment in the United States relies on empirically administered intramuscular ceftriaxone. Diagnostics to predict Neisseria gonorrhoeae ciprofloxacin susceptibility/resistance could enable use of ciprofloxacin, a low-cost, single-dose oral antibiotic, to treat ciprofloxacin-susceptible gonorrhea. Ciprofloxacin resistance in N. gonorrhoeae is overwhelmingly mediated by a single mutation in gyrA at codon 91. Molecular interrogation of this site reliably predicts ciprofloxacin resistance and susceptibility. The Antibacterial Resistance Leadership Group (ARLG) is performing a multicenter, multicompany study to generate regulatory-grade clinical performance data to support Food and Drug Administration submissions of multiple nucleic acid amplification tests to predict ciprofloxacin susceptibility in N. gonorrhoeae. In December 2025, a multidisciplinary group was convened by the ARLG and Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator to discuss a coordinated pathway to enable individualized ciprofloxacin resistance-guided gonorrhea therapy in the United States, acknowledging this will require integration across diagnostics, regulation, guidelines, reimbursement, and implementation. Meeting highlights are presented.

: Trachoma remains endemic in Sudan. A 2009 baseline survey in Al Rahad locality revealed a trachomatous inflammation-follicular (TF) prevalence of 7.1%, prompting azithromycin mass drug administration (MDA). After three MDA rounds (2015–2017), a trachoma impact survey was conducted in 2017. This study’s aim was to estimate the prevalence of clinical signs and ocular Chlamydia trachomatis infection identified with DNA testing. A cross-sectional, cluster-random sampling design was used, and certified graders assessed participants for clinical signs and swabbed children for C. trachomatis . The TF prevalence was 6.3% (95% CI: 4.0–10.0), and C. trachomatis prevalence was 0.8% (95% CI: 0.2–3.1). Chlamydia trachomatis infection was clustered centrally in the locality within communities with high TF prevalence. Despite MDA interventions, TF remained above the established 5% elimination threshold, and C. trachomatis infection was observed. Complementary indicators, such as C. trachomatis infection, should be considered in trachoma programs as they aid in better understanding trachoma endemicity.

Objectives: The demand for point-of-care testing (POCT) increased exponentially during the COVID-19 pandemic, providing a convenient and accessible method of virus detection outside of traditional laboratory settings. As high rates of sexually transmitted infections (STIs) remain a prominent public health concern, POCT for STI detection may offer an option that reduces key barriers to care such as stigma and limited clinic hours. The aim of this narrative review is to identify key facilitators, barriers and gaps related to the acceptability and implementation of STI POCT from patient perspectives in non-traditional settings. Methods: To conduct this narrative review, a comprehensive literature search was conducted using PubMed, Embase and Scopus to identify relevant studies published between 1 January 2015 and May 2025, focusing on patient perspectives and contextual determinants of POCT implementation for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). Search terms included free-text keywords (such as “point of care”) and indexed terms (such as Point-of-Care Testing (MeSH)). Findings were contextualised based on patient perspective data and implementation into non-traditional settings. Results: 40 studies were included in the narrative review, reflecting geographical regions where POCT implementation has been prioritised. Study designs and implementation environments varied. POCT for CT/NG screening generally reported high diagnostic accuracy and reliability as well as increased uptake and high acceptability across settings. Availability, perceived convenience and increased autonomy significantly influenced POCT uptake and implementation among patients. Implementation facilitators included ease of device usage, minimal training and improved quality of care. Implementation barriers primarily focused on logistics, workflow and cost. Conclusions: Community-engaged approaches to designing and implementing STI POC tests in non-traditional settings are necessary to better understand specific needs. High patient satisfaction, device acceptability and improved health outcomes place STI POCT as a promising avenue for strengthening public health efforts against the STI epidemic.

Background: Chlamydia infection remains a global health concern, justifying the need for a chlamydia vaccine. Chlamydia infection rates are highest among young women and men; thus, they would be the target populations for vaccination. However, vaccine availability does not ensure uptake. We conducted a survey among youth to identify factors that may influence chlamydia vaccine acceptability. Methods: Females and males aged 16–29 years seen for care in adolescent, gynecology, student health, and sexual health clinics completed a computer-assisted survey, collecting information on sexual health, health care utilization, vaccination history, and factors related to chlamydia and vaccine acceptability. Results: Of 399 female and 221 male participants, most (93.2%) had heard of chlamydia, 28.1% reported prior chlamydia infection, and 52.6% believed they could acquire chlamydia infection. Interest in chlamydia vaccination was reported by 42.4% females and associated with non-Black race, Hispanic ethnicity, clinic site, previous influenza or COVID-19 vaccination, and awareness of human papillomavirus vaccination. Among males, 44.8% reported chlamydia vaccination interest that was associated with ethnicity, human papillomavirus vaccine awareness, chlamydia awareness, prior chlamydia infection, and possibility of acquiring chlamydia infection. Among all participants, most (82.5%) reported their main motivation for vaccination was to protect themselves and major barriers were concerns about safety (50.0%) and cost (23.1%). The majority (66.0%) reported health care providers as the main resource for vaccine information and were more likely to get vaccinated if recommended by them. Conclusions: Less than half of surveyed youth were interested in receiving a chlamydia vaccine. Findings will guide strategies for chlamydia vaccine implementation.

Background: Point-of-care tests (POCTs) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae offer the potential for rapid diagnosis and treatment, improving patient outcomes and reducing disease transmission. We sought to compile evidence on the accuracy and clinical utility of molecular-based POCTs and near-POCTs for the detection of C. trachomatis and N. gonorrhoeae. Methods: We performed a systematic literature search of 5 electronic databases from January 2009 to January 2024 to understand the performance characteristics and implementation considerations associated with Food and Drug Administration–cleared POCTs and near-POCTs. Results were described in a narrative format. Results: From 3743 identified studies, 64 met our inclusion criteria. As of 2025, there are 4 Food and Drug Administration–cleared POCTs/near-POCTs for detecting C. trachomatis and N. gonorrhoeae, 3 of which are waived by the Clinical Laboratory Improvement Amendments and suitable for use during a patient visit. Evidence suggests that POCTs are most beneficial in symptomatic patients within acute care settings, where they can prevent loss to follow-up and reduce the need for empiric antibiotic treatment. Conclusions: While some POCTs for C. trachomatis and N. gonorrhoeae have achieved regulatory clearance, challenges remain, including the need to expand specimen type clearance to include extragenital specimens, to further improve turnaround times, and to decrease cost for adoption. There is need to optimize the use of POCTs in acute care settings to manage sexually transmitted infections.

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most commonly reported sexually transmitted infections (STIs) in the United States, and their accurate diagnosis is critical for preventing serious health outcomes. Nucleic acid amplification tests (NAATs) are still considered the gold standard for the laboratory diagnosis of chlamydia and gonorrhea due to their high sensitivity and specificity. Since the 2014 CDC laboratory recommendations, several key improvements to FDA-cleared NAATs have been made including expanded specimen types, technology, and process improvements. We conducted a systematic literature search and a narrative review focused on the performance of laboratory-based molecular diagnostics for CT and NG. This systematic review evaluated 145 studies to assess current diagnostic performance, focusing on six key areas: FDA-cleared diagnostic NAATs, self-collected specimens, pooling strategies, time to negativity, confirmatory/repeat testing, and LGV diagnostics. Many assays now include claims for clinician-collected extragenital specimens and self-collected vaginal swabs with high sensitivity (>90%) and specificity (>98%), and the recent FDA authorization of the first self-collection kit for nonclinical settings represents a major milestone in STI care access. However, no NAATs currently have claims for patient-collected extragenital specimens, despite strong evidence of comparable performance and high patient acceptability. Newer versions of assays incorporate dual targets for both CT and NG to enhance positive predictive value and reduce diagnostic escape. While no FDA-cleared assays exist for LGV differentiation, several laboratory-developed tests show promise. Future directions include expanding FDA clearance for self-collected extragenital specimens and developing viability assays to better distinguish active infection from residual nucleic acids. Together, these advances underscore the progress in CT/NG testing and highlight opportunities to further improve diagnostic reach and clinical relevance.

Gay, bisexual, and other men who have sex with men (GBM) in the Southern United States (US) experience high HIV incidence yet have relatively lower HIV pre-exposure prophylaxis (PrEP) uptake, especially among GBM of color. Despite awareness, PrEP use remains insufficient to meaningfully impact the HIV epidemic in the Southern US. PrEP promotions largely focus on PrEP messaging, especially product awareness. Theory-based health promotion research has not explored how to develop promotions that drive PrEP uptake. To close this gap, we explored preferences among GBM in the Southern US for promotion content, format, and platform. Grounded in Andersen’s Model, we conducted semi-structured interviews with HIV-negative GBM, aged 18–39 years, and used inductive and deductive coding for thematic analysis to develop themes and sub-themes to understand promotion preferences. Forty GBM (68% Black, 10% Latino, 53% not using PrEP) completed interviews. Three major themes emerged: (1) content beyond promoting PrEP awareness, (2) using digital devices and media access for promoting PrEP, and (3) platforms for PrEP promotion. GBM in this study preferred digital promotion of PrEP, focusing on access, safety, and effectiveness that is delivered discreetly; promotion in the non-digital space could normalize PrEP use. Creating promotions that address these themes will make promotions more relevant to drive uptake of PrEP in the Southern US.

Background: The Alinity m STI is a nucleic acid amplification testing for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) in one assay. This study evaluated the performance of the Alinity m STI in comparison with other commonly used Food and Drug Administration–cleared assays and laboratory-developed tests across multiple female urogenital specimens. Methods: Clinician-collected and self-collected vaginal swab, endocervical swab, and urine specimens were collected from symptomatic and asymptomatic women across the United States. The Alinity m STI results were compared with the Composite Comparator Algorithm to establish specimen-specific agreement with 6 Food and Drug Administration–cleared assays and 2 laboratory-developed test. Results: In this study population, the prevalence of single infections ranged from 0.8% (NG) to 7.6% (TV), with 3.4% of individuals coinfected with at least 2 pathogens. The overall positive agreements for clinician-collected and self-collected vaginal swab and for endocervical swab were ≥97.5%, ≥98.0%, and ≥97.3%, respectively, for all 4 analytes, with TV showing the lowest agreement for these sample types. The overall positive agreement for urine was ≥99.2% for all 4 targets. The κ score ranged from 0.84 to 0.99 across all analytes and specimen types. Conclusions: The Alinity m STI assay showed excellent concordance with the comparator assays, as demonstrated by strong κ scores in female urogenital specimens.

Background: This study evaluated the performance of the Alinity m sexually transmitted infection (STI) assay that can simultaneously detect Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in comparison with other commonly used Food and Drug Administration–cleared assays and laboratory-developed tests in male urine specimens. Methods: Urine specimens were collected from symptomatic and asymptomatic men across the United States. The Alinity m STI results were compared with the Composite Comparator Algorithm results established for each analyte. Results: The prevalence of single infections ranged from 1.8% for NG and TV to 6.1% for CT, with 2.6% of individuals coinfected with at least 2 STI pathogens. The overall positive agreement was ≥97.5% for all 4 analytes, with MG showing the lowest agreement. The κ score ranged from 0.82 to 0.98 across all analytes. Conclusions: The Alinity m STI assay showed excellent concordance with the comparator assays demonstrated by the strong κ scores in male urine specimens.

Sexually transmitted infections, e.g., Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG), present with similar signs/symptoms and are often treated empirically due to delays in receiving diagnostic test results. This study evaluated the clinical performance of the Cobas Liat CT/NG/MG nucleic acid amplification test (NAAT) in detecting these pathogens in a point-of-care (POC) setting. This non-interventional, multicenter study recruited symptomatic/asymptomatic participants from 13 geographically diverse POC sites across the USA. Prospective clinician- and self-collected specimens (urine/vaginal swabs) were used to determine the sensitivity and specificity of the Cobas Liat CT/NG/MG test relative to the composite reference standard (CRS), determined using a combination of results from three FDA-approved NAATs and one laboratory-developed test. Among 4,800 evaluable participants, 40.4% ( n = 1,941) were symptomatic, and 51.9% ( n = 2,489) were female at birth. The Cobas Liat CT/NG/MG test demonstrated good clinical performance across all specimen types regardless of symptom status, with specificity >97% for each analyte, and sensitivity ≥92%, except female urine (≥CT 87%, NG ≥ 83%, MG ≥ 77%). The test was considered easy to use, and no statistically significant difference in performance results was observed between trained/untrained users. The Cobas Liat CT/NG/MG test demonstrated good clinical performance, with high sensitivity and specificity for CT/NG/MG detection, regardless of symptom status. The assay provides a short turn-around time (approximately 20 min) with centralized testing laboratory accuracy at the POC for self- and clinician-collected samples. POC testing can facilitate rapid pathogen identification and accurate treatment, thereby mitigating the need for empiric treatment. IMPORTANCE: Nucleic acid amplification tests are the preferred method for diagnosing CT and NG infections and are the only reliable tests for MG; however, delays in receiving results can lead to empiric treatment, potentially causing misdiagnosis and overtreatment of STIs. Point-of-care testing could mitigate these issues by enabling rapid pathogen identification and treatment, but no rapid POC tests are currently available for the detection of CT, NG, and MG despite the similarity of symptoms, and these three pathogens being responsible for the majority of symptomatic STIs in some settings. Our findings suggest that the Cobas Liat CT/NG/MG assay may help to reduce reliance on empiric treatment of symptoms and minimize resulting return visits for unresolved infections. Use of the Cobas Liat CT/NG/MG assay may also result in improved patient outcomes, help realize population benefits by reducing the duration of infection and potentially transmission, and reduce healthcare costs.