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2.
Sex Transm Dis ; 51(6): 388-392, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38733972

ABSTRACT

BACKGROUND: Standard-of-care nucleic acid amplification tests (routine NAATs) for Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) can take several days to result and therefore delay treatment. Rapid point-of-care GC/CT NAAT (rapid NAAT) could reduce the time to treatment and therefore onward transmission. This study evaluated the incremental cost per infectious day averted and overall cost of implementation associated with rapid compared with routine NAAT. METHODS: Prospective sexually transmitted infection (STI) treatment data from men who have sex with men and transgender women in San Diego who received rapid NAAT between November 2018 and February 2021 were evaluated. Historical time from testing to treatment for routine NAAT was abstracted from the literature. Costs per test for rapid and routine NAAT were calculated using a micro-costing approach. The incremental cost per infectious day averted comparing rapid to routine NAAT and the costs of rapid GC/CT NAAT implementation in San Diego Public Health STI clinics were calculated. RESULTS: Overall, 2333 individuals underwent rapid NAAT with a median time from sample collection to treatment of 2 days compared with 7 to 14 days for routine NAAT equating to a reduction of 5 to 12 days. The cost of rapid and routine GC/CT NAAT was $57.86 and $18.38 per test, respectively, with a cost-effectiveness of between $2.43 and $5.82 per infectious day averted. The incremental cost of rapid NAAT improved when at least 2000 tests were performed annually. CONCLUSIONS: Although rapid GC/CT NAAT is more expensive than routine testing, the reduction of infectious days between testing and treatment may reduce transmission and provide improved STI treatment services to patients.


Subject(s)
Chlamydia Infections , Chlamydia trachomatis , Gonorrhea , Homosexuality, Male , Neisseria gonorrhoeae , Nucleic Acid Amplification Techniques , Humans , Male , Gonorrhea/diagnosis , Gonorrhea/economics , Chlamydia Infections/diagnosis , Chlamydia Infections/economics , Nucleic Acid Amplification Techniques/economics , Neisseria gonorrhoeae/isolation & purification , Chlamydia trachomatis/isolation & purification , Adult , California/epidemiology , Cost-Benefit Analysis , Prospective Studies , Female , Point-of-Care Testing/economics , Transgender Persons
3.
PLoS One ; 19(5): e0302785, 2024.
Article in English | MEDLINE | ID: mdl-38768150

ABSTRACT

INTRODUCTION: The rates of gonorrhea and chlamydia have been increasing in the years preceding the COVID19 pandemic. Because most gonorrhea and chlamydia infections are located in the oropharynx and rectum for men who have sex with men (MSM), and because at-home self-collected swabs for these infections are not licensed by Health Canada or the United States Food and Drug Administration, decreased accessed to in-person care during and since the COVID19 pandemic potentially means missed case findings. OBJECTIVES: To evaluate the performance of at-home self-collected pharyngeal and rectal swabs for gonorrhea and chlamydia nucleic acid amplification testing. METHODOLOGY: All persons who contacted our Sexual Health Clinic and who had a clinical indication to complete oral and/or rectal swabs for gonorrhea and chlamydia were invited to complete at-home swabs in advance of their scheduled appointments. We mailed swabs and instructions to those who consented. Participants brought these swabs to their scheduled in clinic appointments, where we repeated the same swabs. All matching swabs were sent to the laboratory for analysis to determine concordance. RESULTS: From September 8, 2022 to July 18, 2023, we enrolled 296 eligible participants who provided 1184 swabs. For analysis, cancelled specimens and specimens with invalid results were excluded, leaving 1032 swabs for comparison. We identified 66 STI diagnoses in 47 unique participants. Overall accuracy was high (exceeding 99%), except for rectal chlamydia, which was 96.0%. While the performance of self-swabs for chlamydia was lower compared to gonorrhea, at-home swabs identified six chlamydia infections that were missed by in-clinic collected swabs (two pharyngeal, four rectal). Removing these six cases as "false positives" increased overall accuracy for chlamydia detection to 99.7% (pharyngeal) and 97.8% (rectal). CONCLUSION: Self-collected at-home swabs had good performance acceptable for gonorrhea and chlamydia nucleic acid amplification testing.


Subject(s)
Chlamydia Infections , Chlamydia trachomatis , Gonorrhea , Neisseria gonorrhoeae , Pharynx , Rectum , Specimen Handling , Humans , Chlamydia trachomatis/isolation & purification , Chlamydia trachomatis/genetics , Chlamydia Infections/diagnosis , Chlamydia Infections/microbiology , Gonorrhea/diagnosis , Gonorrhea/microbiology , Male , Neisseria gonorrhoeae/isolation & purification , Neisseria gonorrhoeae/genetics , Rectum/microbiology , Pharynx/microbiology , Specimen Handling/methods , Adult , Female , Nucleic Acid Amplification Techniques/methods , Homosexuality, Male , Middle Aged , Self Care , Young Adult
4.
Przegl Epidemiol ; 77(4): 466-475, 2024 May 20.
Article in English, Polish | MEDLINE | ID: mdl-38783655

ABSTRACT

BACKGROUND: The incidence of gonorrhoea at the European level increased over 2012-2019, decreased in 2020, and then reached higher values in 2021 than in 2019. OBJECTIVE: Analysis in the descriptive epidemiology scheme of gonorrhoea notification in surveillance in Poland in 2021 (being the second year of the COVID-19 pandemic). MATERIAL AND METHODS: Case-base data from surveillance of gonorrhoea were used: confirmed case (meeting laboratory criteria), probable (meeting clinical criteria and contact with confirmed case) and possible (only in Poland - physician diagnosed gonorrhoea, no information available for proper classification). Statistic Poland data was used to calculate the indicators. Data on patients treated in dermatology-venereology clinics between 2019-2021 were taken from the Bulletins of the Ministry of Health. RESULTS: The incidence of gonorrhoea in Poland in 2021 was only a fraction of recorded in the EU/EEA (0.74 vs. 13.7/100000)-similar to the first pandemic year and were about half of those notified in the 2019 (the peak year; 281 vs. 522 cases). There were 15.5 men per one female (incidence: 1.6/100000 men, 0.1/100000 women). Every second case was among aged 25-34 (49.62%), every fourth-aged 35-44 (23.11%). Under 15, no cases were reported. The predominant site was the genitourinary (excluding missing data: 85.3%). The cases with missing information on transmision increased (49.1%; aged 45+: 72.0%, women: 76.5%). Delays in reporting data were identified (greater than in 2019, however, less than in 2020), ~17% cases were from 2019-2020. Dermatology-venerology clinics treated 385 people - less than in 2020, however, more than reported in epidemiological surveillance (vs. 281). CONCLUSIONS: The COVID-19 pandemic has influenced on the surveillance system in Poland. There are difficulties in interpreting the epidemiological trend. It is necessary to: 1) intensify systemic solutions in the area of prevention, including sexual partners; 2) raise the awareness of healthcare professionals and sanitary inspection workers on the role of collecting epidemiological information.


Subject(s)
COVID-19 , Gonorrhea , Humans , Poland/epidemiology , Gonorrhea/epidemiology , Gonorrhea/diagnosis , Male , Female , Adult , Incidence , COVID-19/epidemiology , Middle Aged , Young Adult , SARS-CoV-2 , Adolescent , Age Distribution , Sex Distribution , Urban Population/statistics & numerical data , Aged , Rural Population/statistics & numerical data
5.
West J Emerg Med ; 25(3): 358-367, 2024 May.
Article in English | MEDLINE | ID: mdl-38801042

ABSTRACT

Introduction: Bacterial urinary tract infections (UTI) and some sexually transmitted infections (STI) can have overlapping signs and symptoms or nonspecific findings, such as pyuria on urinalysis. Furthermore, results from the urine culture and the nucleic acid amplification test for an STI may not be available during the clinical encounter. We sought to determine whether gonorrhea, chlamydia, and trichomoniasis are associated with bacteriuria, information that might aid in the differentiation of STIs and UTIs. Methods: We used multinomial logistic regression to analyze 9,650 encounters of female patients who were aged ≥18 years and who underwent testing for STIs. The ED encounters took place from April 18, 2014-March 7, 2017. We used a multivariable regression analysis to account for patient demographics, urinalysis findings, vaginal wet-mount results, and positive or negative (or no) findings from the urine culture and testing for Neisseria gonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis. Results: In multivariable analysis, infection with T vaginalis, N gonorrhoeae, or C trachomatis was not associated with having a urine culture yielding 10,000 or more colony-forming units per mililiter (CFU/mL) of bacteria compared with a urine culture yielding less than 10,000 CFU/mL or no urine culture obtained. The diagnosis of a UTI in the ED was not associated with having a urine culture yielding 10,000 or more CFU/mL compared with a urine culture yielding less than 10,000 CFU/mL. Conclusion: After adjusting for covariates, no association was observed between urine culture results and testing positive for trichomoniasis, gonorrhea, or chlamydia. Our results suggest that having a concurrent STI and bacterial UTI is unlikely.


Subject(s)
Gonorrhea , Sexually Transmitted Diseases , Urinalysis , Urinary Tract Infections , Humans , Female , Adult , Urinary Tract Infections/diagnosis , Urinary Tract Infections/microbiology , Urinary Tract Infections/urine , Sexually Transmitted Diseases/urine , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/microbiology , Gonorrhea/diagnosis , Gonorrhea/urine , Urinalysis/methods , Chlamydia Infections/urine , Chlamydia Infections/diagnosis , Middle Aged , Chlamydia trachomatis/isolation & purification , Emergency Service, Hospital , Trichomonas vaginalis/isolation & purification , Bacteriuria/diagnosis , Bacteriuria/urine , Bacteriuria/microbiology , Young Adult , Neisseria gonorrhoeae/isolation & purification , Urine/microbiology , Retrospective Studies , Adolescent , Trichomonas Infections/diagnosis , Trichomonas Infections/urine
6.
West J Emerg Med ; 25(3): 382-388, 2024 May.
Article in English | MEDLINE | ID: mdl-38801045

ABSTRACT

Introduction: The incidence of sexually transmitted infections (STI) increased in the United States between 2017-2021. There is limited data describing STI co-testing practices and the prevalence of STI co-infections in emergency departments (ED). In this study, we aimed to describe the prevalence of co-testing and co-infection of HIV, hepatitis C virus (HCV), syphilis, gonorrhea, and chlamydia, in a large, academic ED. Methods: This was a single-center, retrospective cross-sectional study of ED patients tested for HIV, HCV, syphilis, gonorrhea or chlamydia between November 27, 2018-May 26, 2019. In 2018, the study institution implemented an ED-based infectious diseases screening program in which any patient being tested for gonorrhea/chlamydia was eligible for opt-out syphilis screening, and any patient 18-64 years who was having blood drawn for any clinical purpose was eligible for opt-out HIV and HCV screening. We analyzed data from all ED patients ≥13 years who had undergone STI testing. The outcomes of interest included prevalence of STI testing/co-testing and the prevalence of STI infection/co-infection. We describe data with simple descriptive statistics. Results: During the study period there were 30,767 ED encounters for patients ≥13 years (mean age: 43 ± 14 years, 52% female), and 7,866 (26%) were tested for at least one of HIV, HCV, syphilis, gonorrhea, or chlamydia. We observed the following testing frequencies (and prevalence of infection): HCV, 7,539 (5.0%); HIV, 7,359 (0.9%); gonorrhea, 574 (6.1%); chlamydia, 574 (9.8%); and syphilis, 420 (10.5%). Infectious etiologies with universal testing protocols (HIV and HCV) made up the majority of STI testing. In patients with syphilis, co-infection with chlamydia (21%, 9/44) and HIV (9%, 4/44) was high. In patients with gonorrhea, co-infection with chlamydia (23%, 8/35) and syphilis (9%, 3/35) was high, and in patients with chlamydia, co-infection with syphilis (16%, 9/56) and gonorrhea (14%, 8/56) was high. Patients with HCV had low co-infection proportions (<2%). Conclusion: Prevalence of STI co-testing was low among patients with clinical suspicion for STIs; however, co-infection prevalence was high in several co-infection pairings. Future efforts are needed to improve STI co-testing rates among high-risk individuals.


Subject(s)
Coinfection , Emergency Service, Hospital , Gonorrhea , HIV Infections , Hepatitis C , Mass Screening , Sexually Transmitted Diseases , Syphilis , Humans , Cross-Sectional Studies , Female , Retrospective Studies , Adult , Male , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Coinfection/epidemiology , Coinfection/diagnosis , Gonorrhea/diagnosis , Gonorrhea/epidemiology , Syphilis/diagnosis , Syphilis/epidemiology , Prevalence , Middle Aged , Hepatitis C/epidemiology , Hepatitis C/diagnosis , Mass Screening/methods , HIV Infections/epidemiology , HIV Infections/diagnosis , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Adolescent , Young Adult
7.
Diagn Microbiol Infect Dis ; 109(3): 116336, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38723452

ABSTRACT

Current guideline recommends the use of two identification methods for Neisseria gonorrhoeae. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF) is now used for primary identification and may be sufficient for definitive identification of N. gonorrhoeae. The performance of three secondary tests (BactiCard, RapID NH and NET test) were compared using 45 bacterial isolates, including 37 Neisseria species. These secondary tests demonstrated diminished specificity (67% - 88%) for N. gonorrhoeae compared with MALDI-TOF. Additionally, data from six clinical microbiology laboratories was used to compare confirmatory test costs and the agreement of results with MALDI-TOF. Discrepancies were documented for 9.4% of isolates, though all isolates (n= 288) identified by MALDI-TOF as N. gonorrhoeae were confirmed by the reference laboratory. These data demonstrate that MALDI-TOF alone is sufficient for N. gonorrhoeae identification, as secondary did not add diagnostic value but do add costs to the testing process.


Subject(s)
Gonorrhea , Neisseria gonorrhoeae , Sensitivity and Specificity , Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization , Neisseria gonorrhoeae/isolation & purification , Neisseria gonorrhoeae/classification , Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization/methods , Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization/economics , Humans , Gonorrhea/diagnosis , Gonorrhea/microbiology , Bacteriological Techniques/economics , Bacteriological Techniques/methods
8.
Sex Transm Infect ; 100(4): 226-230, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38702191

ABSTRACT

OBJECTIVES: Antibiotic resistance in gonorrhoea is of significant public health concern with the emergence of resistance to last-line therapies such as ceftriaxone. Despite around half of Neisseria gonorrhoeae isolates tested in the UK being susceptible to ciprofloxacin, very little ciprofloxacin is used in clinical practice. Testing for the S91F mutation associated with ciprofloxacin resistance is now available in CE-marked assays and may reduce the requirement for ceftriaxone, but many patients are treated empirically, or as sexual contacts, which may limit any benefit. We describe the real-world impact of such testing on antimicrobial use and clinical outcomes in people found to have gonorrhoea in a large urban UK sexual health clinic. METHODS: Molecular ciprofloxacin resistance testing (ResistancePlus GC assay (SpeeDx)) was undertaken as an additional test after initial diagnosis (m2000 Realtime CT/NG assay (Abbott Molecular)) in those not already known to have had antimicrobial treatment. Data from a 6-month period (from March to September 2022) were analysed to determine treatment choice and treatment outcome. RESULTS: A total of 998 clinical samples tested positive for N. gonorrhoeae in 682 episodes of infection. Of the 560 (56%) samples eligible for resistance testing, 269 (48.0%) were reported as wild-type, 180 (32.1%) were predicted to be resistant, 63 (11.3%) had an indeterminate resistance profile, and in 48 (8.6%) samples, N. gonorrhoeae was not detected. Ciprofloxacin was prescribed in 172 (75%) of 228 episodes in which the wild-type strain was detected. Four (2%) of those treated with ciprofloxacin had a positive test-of-cure sample by NAAT, with no reinfection risk. All four had ciprofloxacin-susceptible infection by phenotypic antimicrobial susceptibility testing. CONCLUSIONS: In routine practice in a large UK clinic, molecular ciprofloxacin resistance testing led to a significant shift in antibiotic use, reducing use of ceftriaxone. Testing can be targeted to reduce unnecessary additional testing. Longer term impact on antimicrobial resistance requires ongoing surveillance.


Subject(s)
Anti-Bacterial Agents , Ciprofloxacin , Drug Resistance, Bacterial , Gonorrhea , Microbial Sensitivity Tests , Neisseria gonorrhoeae , Humans , Ciprofloxacin/therapeutic use , Ciprofloxacin/pharmacology , Gonorrhea/drug therapy , Gonorrhea/diagnosis , Gonorrhea/microbiology , Neisseria gonorrhoeae/drug effects , Neisseria gonorrhoeae/genetics , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/pharmacology , Drug Resistance, Bacterial/genetics , Male , Female , Adult , United Kingdom , Ceftriaxone/therapeutic use , Ceftriaxone/pharmacology , Mutation , Young Adult , Middle Aged
9.
Sci Rep ; 14(1): 10496, 2024 05 07.
Article in English | MEDLINE | ID: mdl-38714714

ABSTRACT

The use of self-collected specimens as an alternative to healthcare worker-collected specimens for diagnostic testing has gained increasing attention in recent years. This systematic review aimed to assess the diagnostic accuracy of self-collected specimens compared to healthcare worker-collected specimens across different sexually transmitted infections (STIs) including Chlamydia trachomatis (CT), human papillomavirus (HPV), Mycoplasma genitalium (MG), Neisseria gonorrhoea (NG), Treponema pallidum and Trichomonas vaginalis (TV) in females. A rigorous process was followed to screen for studies in various electronic databases. The quality of included studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. There were no studies on syphilis that met the criteria for inclusion in the review. A total of six studies for chlamydia, five studies for HPV, four studies for MG, and seven studies for gonorrhoea and trichomoniasis were included in the review. However, not all studies were included in the sub-group meta-analysis. The analysis revealed that self-collected specimens demonstrated comparable diagnostic accuracy to healthcare worker-collected specimens across most STIs. This indicates that the diagnostic accuracy of self-collected specimens can provide accurate results and enhance access to diagnostic testing, potentially improving healthcare service delivery. Future research should further explore the diagnostic accuracy of self-collected specimens in larger and more diverse populations.


Subject(s)
Health Personnel , Sexually Transmitted Diseases , Specimen Handling , Humans , Female , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/microbiology , Specimen Handling/methods , Neisseria gonorrhoeae/isolation & purification , Gonorrhea/diagnosis , Chlamydia trachomatis/isolation & purification
12.
Article in English | MEDLINE | ID: mdl-38597520

ABSTRACT

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.


Subject(s)
Gonorrhea , HIV Infections , Mpox (monkeypox) , Sexual and Gender Minorities , Sexually Transmitted Diseases , Adult , Humans , Male , Brazil/epidemiology , Cross-Sectional Studies , Demography , Disease Outbreaks , Gonorrhea/diagnosis , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Infections/complications , Homosexuality, Male , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology
13.
J Med Microbiol ; 73(4)2024 Apr.
Article in English | MEDLINE | ID: mdl-38591530

ABSTRACT

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.


Subject(s)
Chlamydia Infections , Gonorrhea , Mycoplasma Infections , Mycoplasma genitalium , Sexually Transmitted Diseases , Trichomonas vaginalis , Humans , Real-Time Polymerase Chain Reaction , Chlamydia trachomatis/genetics , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Trichomonas vaginalis/genetics , Neisseria gonorrhoeae/genetics , Mycoplasma genitalium/genetics , Mycoplasma Infections/diagnosis , Mycoplasma Infections/epidemiology , Tomography, X-Ray Computed , Chlamydia Infections/diagnosis , Gonorrhea/diagnosis , Gonorrhea/epidemiology
14.
Emerg Infect Dis ; 30(13): S62-S67, 2024 04.
Article in English | MEDLINE | ID: mdl-38561843

ABSTRACT

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.


Subject(s)
Chlamydia Infections , Coinfection , Gonorrhea , Young Adult , Adolescent , Male , Female , Humans , Gonorrhea/diagnosis , Gonorrhea/epidemiology , Gonorrhea/prevention & control , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Utah/epidemiology , Coinfection/epidemiology , Neisseria gonorrhoeae , Chlamydia trachomatis , Correctional Facilities , Prevalence , Mass Screening/methods
16.
JAMA ; 331(20): 1701-1702, 2024 05 28.
Article in English | MEDLINE | ID: mdl-38683579

ABSTRACT

This Viewpoint discusses the US Food and Drug Administration's authorization of marketing an at-home testing system for chlamydia and gonorrhea as a good first step in boosting access to screening and treatment and in reducing infection rates.


Subject(s)
Chlamydia Infections , Gonorrhea , Humans , Gonorrhea/diagnosis , Chlamydia Infections/diagnosis , Neisseria gonorrhoeae/isolation & purification , Chlamydia trachomatis/isolation & purification , Female , Male , Self-Testing
17.
BMC Infect Dis ; 24(Suppl 1): 277, 2024 Mar 04.
Article in English | MEDLINE | ID: mdl-38438953

ABSTRACT

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.


Subject(s)
Gonorrhea , Trichomonas vaginalis , Female , Humans , Trichomonas vaginalis/genetics , Chlamydia trachomatis/genetics , Gonorrhea/diagnosis , Gonorrhea/epidemiology , Guatemala/epidemiology , Morocco/epidemiology , South Africa/epidemiology , Neisseria gonorrhoeae/genetics , Australia , Point-of-Care Testing
18.
Microb Genom ; 10(3)2024 Mar.
Article in English | MEDLINE | ID: mdl-38529900

ABSTRACT

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.


Subject(s)
Anti-Infective Agents , Gonorrhea , Nanopore Sequencing , Humans , Neisseria gonorrhoeae/genetics , Anti-Bacterial Agents/pharmacology , Phylogeny , Drug Resistance, Bacterial/genetics , Gonorrhea/diagnosis , DNA
19.
PLoS One ; 19(3): e0290574, 2024.
Article in English | MEDLINE | ID: mdl-38489281

ABSTRACT

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.


Subject(s)
Antimicrobial Stewardship , Gonorrhea , HIV Infections , Sexually Transmitted Diseases , Urethral Diseases , Humans , Male , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , HIV Infections/diagnosis , Uganda/epidemiology , Anti-Bacterial Agents/therapeutic use , Case Management , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/drug therapy , Sexually Transmitted Diseases/epidemiology , Gonorrhea/diagnosis , Gonorrhea/drug therapy , Gonorrhea/epidemiology , Prevalence
20.
Sex Transm Infect ; 100(4): 222-225, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38553038

ABSTRACT

OBJECTIVES: We aimed to assess whether a self-collected oral rinse was non-inferior to clinician-collected oropharyngeal swabs to detect Neisseria gonorrhoeae (Ng) using culture and nucleic acid amplification tests (NAAT) among men who have sex with men (MSM), and whether Ng may still be detected in oral rinses for a minimum of 5 days after collection. METHODS: MSM with a positive Ng result in an oropharyngeal or pooled sample (oropharynx, urethra and anorectum) were approached. Clinician-collected oropharyngeal swabs and oral rinses (15 mL sterile water) were taken. Ng culture and NAAT (Abbott 2000m RealTime System CT/NG assay and in-house PCR) were performed. Diagnostic accuracy was assessed using sensitivity and specificity, and agreement between both techniques using Cohen's kappa statistic. Aliquots of positive oral rinses were left at room temperature for a minimum of 5 days and reanalysed using NAAT. Lastly, participants filled in a questionnaire to explore perceptions of both methods. RESULTS: We included 100 participants between June 2022 and October 2023. 45 individuals (45 of 100) had a positive Ng result in either the oral rinses (42 of 45, 93%) or the swabs (36 of 45, 80%). Sensitivity was higher for oral rinses than swabs (sensitivity=0.93/0.80, specificity=1.0/1.0, respectively) and agreement between both techniques was good (kappa=0.75, p<0.001). Of the 42 positive oral rinses, 37 remained positive after a minimum of 5 days (88.1%). Using culture, 18 individuals had a positive Ng result in either the oral rinses (8 of 18, 44%) or the swabs (16 of 18, 88%). Most participants found the oral rinse easy or very easy to use and would be willing to use the oral rinse for home-based sampling. CONCLUSION: We detected more oropharyngeal Ng infections via NAAT using oral rinses than swab samples. However, swabs were better than oral rinses for culturing Ng. Oral rinses might allow for home-based self-sampling to detect oropharyngeal Ng.


Subject(s)
Gonorrhea , Homosexuality, Male , Neisseria gonorrhoeae , Nucleic Acid Amplification Techniques , Oropharynx , Sensitivity and Specificity , Specimen Handling , Humans , Male , Neisseria gonorrhoeae/isolation & purification , Neisseria gonorrhoeae/genetics , Gonorrhea/diagnosis , Adult , Oropharynx/microbiology , Specimen Handling/methods , Belgium , Nucleic Acid Amplification Techniques/methods , Middle Aged , Urethra/microbiology , Young Adult
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