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.

Introduction Crowdsourcing engages the community to create and share solutions; this participatory method could be used to create effective pre-exposure prophylaxis (PrEP) promotions. We explored acceptability of using crowdsourcing to develop PrEP promotions among sexual minority men (SMM) and sexual health providers in Alabama. Methods We conducted focus group discussions (FGDs) with SMM and interviews with sexual health providers with guides grounded in the Theoretical Framework of Acceptability. We employed thematic analysis through deductive and inductive coding. Results Ten SMM (60% Black, 50% younger than 30 years) participated in FGDs, and six providers completed interviews. We found four themes: 1) Personal identity and background inform the participation and products of crowdsourcing, 2) SMM and providers are motivated to participate in crowdsourcing, 3) Crowdsourcing participants require resources to effectively engage, and 4) Logistic and social factors are barriers to crowdsourcing participation. Discussion Crowdsourcing as a strategy to create PrEP promotions in the Southern United states would be acceptable and feasible in the correct context. These formative, yet novel, findings demonstrate that SMM and sexual health providers would be willing to participate in crowdsourcing events and also provide key insight to design crowdsourcing events.

Background The detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) relies heavily on highly sensitive and specific assays. While nasopharyngeal (NP) specimens are considered the gold standard, it is crucial that current assays also support the use of anterior nasal swab (NS) specimens, as they can be more suitable in situations where NP specimen collection is difficult or impractical. Methods Paired NP and NS specimens prospectively collected from symptomatic and asymptomatic participants were utilized to evaluate the BD Respiratory Viral Panel - SCV2 for BD MAX™ System (BD RVP SCV2) clinical performance against a composite comparator of three CE-marked assays: cobas® SARS-CoV-2, Aptima® SARS-CoV-2, and Lyra® SARS-CoV-2. Concordance between at least two assays established a positive or negative comparator result. Each specimen was divided into four aliquots, one for each assay. BD RVP SCV2 performance was assessed by comparing results from NP specimens (NP vs NP), NS specimens (NS vs NS), and NS results with paired NP comparator results (NS vs NP). Positive and negative percent agreements (PPA and NPA) were calculated for all comparisons. Results Combined symptomatic and asymptomatic specimens, when tested with the BD RVP SCV2 assay, met all set acceptance criteria, with PPAs of 98.7% (NP vs NP), 98.4% (NS vs NS), and 92.6% (NS vs NP) while NPAs ranged from 97.7% to 98.0%. Conclusions These findings confirm that the BD Respiratory Viral Panel - SCV2 for BD MAX System performs well for detecting SARS-CoV-2 in NP and NS specimens from symptomatic and asymptomatic populations.

BACKGROUND: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. METHODS: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. RESULTS: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. CONCLUSIONS: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.

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.

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:Congenital syphilis rates in the United States have increased significantly over the past decade. Syphilis is a curable infection with the potential for lifelong sequelae in the absence of timely diagnosis and treatment. Routine serologic syphilis screening is universally recommended during prenatal care with the traditional or the reverse diagnostic algorithm. False positive syphilis serologic testing in pregnancy can occur and comparative performance data for recommended algorithms in pregnancy are limited. Primary objective:To compare the performance of the traditional algorithm and the reverse algorithm for the diagnosis of syphilis in pregnancy. Study design:This retrospective analysis included pregnant women who delivered at our tertiary care center in the Southeastern United States during a period of increasing syphilis rates with testing performed between November 1, 2012 and December 31, 2019. We evaluated results according to the diagnostic algorithm used by facility laboratories at the time of syphilis screening (traditional 2012-2014 and reverse 2015-2019). Screen positivity, false positive test results, confirmed infection, and pregnancy outcomes were compared between the two periods. For secondary outcomes, multivariable logistic regression models were conducted to identify factors associated with false positive screening results and confirmed infection including maternal age, race, insurance status, test timing and location, and human immunodeficiency virus/sexually transmitted infection coinfection. Results:Of 26,519 pregnant women tested for syphilis during the study period, 8781 were evaluated using the traditional algorithm and 17,738 were evaluated using the reverse algorithm. Mean age was 27.9 years, 85.3% of women were initially screened in the first trimester, and the mean number of syphilis testing episodes in pregnancy was 2.3. Screen positivity was 0.6% among women screened using the traditional algorithm compared to 1.6% for those tested with the reverse algorithm (p < 0.001). The proportion diagnosed with confirmed infection was similar in both algorithms: 0.2% traditional algorithm versus 0.3% reverse algorithm. Among those who screened positive with follow-up testing performed, 52.4% and 60.4% were classified as falsely positive with negative confirmatory testing with the traditional algorithm and the reverse algorithms, respectively. In an adjusted model, delayed testing in pregnancy (odds ratio [OR], 22.8; 95% confidence interval [CI], 14.1-36.8 for ≥28 weeks compared to <14 weeks), inpatient or ER screening location (OR, 22.7; 95% CI, 13.4-38.4 vs. clinic), Black race (OR, 5.4; 95% CI, 3.2-9.2) compared to White, other sexually transmitted infection in pregnancy (OR, 2.2; 95% CI, 1.2-4.1]), and lack of private insurance (OR, 1.8; 95% CI, 1.2-2.9) were associated with false positive syphilis screening. The same factors were associated with confirmed syphilis in pregnancy except for STI coinfection. The reverse algorithm was only associated with false positive screening in the crude model (OR, 2.2; 95% CI, 1.4-3.5). Conclusion:Syphilis screen positivity rates in pregnancy were nearly twice as high with the reverse algorithm compared to the traditional algorithm. Since false positive screening tests were common, improved diagnostic testing for active infection in pregnancy is needed.

Ethical abuses related to syphilis research have led to significant barriers to implementation of syphilis clinical trials. Insights from an expert meeting included ways to actively involve participants in clinical research, considerations for community engagement, and strategies to enhance clinical syphilis research.

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.

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.

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: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.

BACKGROUND:Extragenital (oropharyngeal and anorectal) Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (or gonococci [GC]) infections are underdiagnosed. Here we report sensitivity and specificity estimates that were obtained from the multiplex, polymerase chain reaction-based BD CTGCTV2 (CTGCTV2) assay, which simultaneously detects CT and GC from extragenital specimens on the high-throughput BD COR (COR) system. METHODS:Testing on the index assay used remnant (collected during a predicate, registrational trial) oropharyngeal (n = 2318) or anorectal (n = 2292) specimens, stored in PreservCyt ThinPrep liquid-based cytology media, from sexually active individuals (≥15 years of age). A composite comparator algorithm was used to define infectious status in the predicate study, which consisted of a 2 out of 3 agreement from Food and Drug Administration-cleared CT/GC molecular assays for a reference-positive or reference-negative result. Results obtained from the CT/GC assay on the COR were compared with the predefined composite comparator algorithm. RESULTS:Testing for CT on COR had an estimated sensitivity of 100% (95% confidence interval, 86.2%-100%) and 97.7% (93.5%-99.2%) from oropharyngeal and anorectal specimens, respectively. GC testing on COR resulted in sensitivity estimates of 92.8% (85.8%-96.5%) and 95.8% (89.7%-98.4%) from oropharyngeal and anorectal specimens, respectively. Specificity estimates for CT were 99.8% (99.5%-99.9%) and 99.4% (99.0%-99.7%), respectively. For GC, specificity estimates were 99.5% (99.1%-99.7%) and 99.8% (99.5%-99.9%) for oropharyngeal and anorectal specimens, respectively. CONCLUSIONS:CTGCTV2 performance on COR was accurate when testing oropharyngeal and anorectal specimens.

This study aimed to better understand the importance of CD8 T cell responses in protective immunity to chlamydia. In women evaluated for reinfection at a 3-month follow-up visit after treatment for chlamydia, the presence or magnitude of Chlamydia trachomatis-specific CD8 interferon-gamma (IFN-γ) responses to Momp and Pgp3 peptide pools was not associated with reinfection status, despite having an increased frequency of responses compared to C. trachomatis CD4-specific T cells. However, reinfected women with detectable interferon-gamma (IFN-γ)-producing CD8 T cells had lower C. trachomatis bacterial load compared to women without these CD8 T cell responses. Moreover, the frequency of IFN-γ-producing CD8 T cells was inversely associated with C. trachomatis bacterial load. We further determined that C. trachomatis-specific IFN-γ-producing CD8 T cells were predominately late differentiated effector memory T cells that re-expressed CD45RA (Temra; CCR7-CD45RA+) or effector memory T cells (Tem; CCR7-CD45RA-). Together, these data support the concept that CD8 T cells may contribute to protective immunity against chlamydia in women.

Objectives We evaluated Mycoplasma genitalium (MG) positivity and co-infection with Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG), based on results from a trial assessing clinical performance of the Cobas® Liat CT/NG/MG point-of-care test. Methods A prospective, US, multicenter, noninterventional study assessed MG positivity in prospective urine samples (male) and clinician-collected vaginal swabs (female) from symptomatic/asymptomatic patients aged ≥14 years attending various clinical settings. Participants were designated positive or negative for MG, CT, and NG based on combined results from three US Food and Drug Administration-approved assays and one laboratory-developed test. MG co-infection with CT and/or NG was assessed. Results Among 4818 evaluable participants, median age was 35.0 years (range: 15.0-81.0), 40.3% were symptomatic, and 51.6% were assigned female sex at birth. MG positivity was 9.6% overall (symptomatic participants: 11.6%; asymptomatic participants: 8.2%). Among 4811 participants with valid results for all analytes, 0.1% were positive for MG, CT, and NG, 1.0% were co-infected with MG/CT; and 0.3% were co-infected with MG/NG. Conclusions MG positivity was high and MG co-infection with CT was common. These findings improve understanding of MG prevalence and may help inform the targeting of MG screening to specific patient populations. Co-infection data support using multiplex testing to facilitate targeted treatment decisions.