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1.
BMC Infect Dis ; 24(Suppl 1): 313, 2024 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-38486194

RESUMO

INTRODUCTION: International guidelines recommend routine screening for syphilis (aetiological agent: Treponema pallidum subspecies pallidum) amongst key populations and vulnerable populations using tests detecting treponemal and non-treponemal antibodies. Whilst treponemal tests have high sensitivities and specificities, they differ regarding subjective or objective interpretation, throughput and workload. Chemiluminescence immunoassays (CLIAs) are cost- and time-effective automated methods for detecting treponemal antibodies. The Treponema pallidum particle agglutination assay (TPPA) has been considered the "gold standard" treponemal assay, however, this includes a highly manual procedure, low throughput and subjective interpretation. The present multi-country study evaluated the ADVIA Centaur® Syphilis CLIA (Siemens Healthcare) assay compared to the reference SERODIA-TP·PA® (Fujirebio Diagnostics) for the serodiagnosis of syphilis amongst men who have sex with men (MSM). METHOD: 1,485 MSM were enrolled in Brighton (UK), Malta, and Verona (Italy) as part of a larger WHO multi-country and multi-site ProSPeRo study. Ethical approval was obtained. Serum was tested with the ADVIA Centaur® Syphilis CLIA assay and SERODIA-TP·PA®, in accordance with the manufacturers' instructions, for a first round of validation. A second round of validation was carried out for discrepant results that were additionally tested with both Western Blot (Westernblot EUROIMMUN®) and an Immunoblot (INNO-LIA, Fujirebio Diagnostics). Sensitivity, specificity, positive and negative predictive value (PPV and NPV), likelihood ratios (positive/negative), and the Diagnostic Odds Ratio (DOR)/pre-post-test probability (Fagan's nomogram) were calculated. RESULTS: Out of 1,485 eligible samples analysed in the first phase, the SERODIA-TP·PA® identified 360 positive and 1,125 negative cases. The ADVIA Centaur® Syphilis CLIA assay (Siemens) identified 366 positives, missclassifying one TPPA-positive sample. In the second phase, the ADVIA Centaur® Syphilis CLIA resulted in 1 false negative and 4 false positive results. Considering the syphilis study prevalence of 24% (95% CI: 22-26.7), The sensitivity of the ADVIA Centaur® Syphilis CLIA assay was 99.7% (95% CI: 98.5-100), and the specificity was 99.4% (95% CI: 98.7-99.7). The ROC area values were 0.996 (95% CI: 0.992-0.999), and both the PPV and NPV values were above 98% (PPV 98.1%, 95% CI: 96.1-99.2; NPV 99.9%, 95% CI: 99.5-100). CONCLUSIONS: The ADVIA Centaur® Syphilis CLIA assay showed similar performance compared to the SERODIA-TP·PA®. Considering the study is based on QUADAS principles and with a homogeneous population, results are also likely to be generalisable to MSM population but potentially not applicable to lower prevalence populations routinely screened for syphilis. The automated CLIA treponemal assay confirmed to be accurate and appropriate for routine initial syphilis screening, i.e. when the reverse testing algorithm is applied.


Assuntos
Minorias Sexuais e de Gênero , Sífilis , Masculino , Humanos , Treponema pallidum , Homossexualidade Masculina , Anticorpos Antibacterianos , Sorodiagnóstico da Sífilis/métodos , Testes Sorológicos/métodos , Sensibilidade e Especificidade , Medições Luminescentes/métodos , Aglutinação
2.
BMC Infect Dis ; 24(Suppl 1): 224, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38418963

RESUMO

BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections have increased globally. Asymptomatic infections represent a significant risk of long-term complications. Men who have sex with men (MSM) are disproportionally affected, underscoring the need to offer screening programmes to this population. CT/NG Point of Care Testing (POCT) constitutes a strategic tool to improve the continuum of STI care, however extensive real-life evaluations amongst at risk populations are lacking. The aim of this study is to estimate the GeneXpert CT/NG assay performance and usability for CT and NG at genital and extragenital sites for screening amongst MSM. METHODS: This study was a multi-site sexual health clinic-based evaluation (Italy, Malta and Peru) with consecutive enrolment. A first void urine sample (divided in two aliquots), two oropharyngeal and two anorectal swabs were collected for each study participant. One specimen set (one for each anatomical site) was tested with the dual index test (Cepheid) at the clinics by the healthcare staff, the other set with FDA/CE approved Nucleic Acid Amplification Tests (NAATs) at the laboratory. Clinical sites and reference laboratories participated in an internal and external quality control programme. Sensitivity, specificity, positive and negative likelihood ratios, positive and negative predictive values for each anatomical site were estimated using a meta-analytic approach. RESULTS: One thousand seven hundred two MSM were recruited across all clinical sites for a total of 5049 biological specimens. NG and CT were respectively detected in 274 and 287 of samples. Overall, the NG POCT sensitivity and specificity was 91.43% and 99.75% in urine (LR + 372.80, LR- 0.09), 89.68% and 99.55% in rectal specimens (LR + 197.30, LR- 0.10) and 75.87% and 98.77% at the pharynx respectively (LR + 61.94, LR- 0.24). The CT component of the POCT sensitivity was 84.82% and specificity 99.63% in urine (LR + 228.68, LR- 0.15), 78.07% and 99.19% respectively on rectal site (LR + 96.23, LR-0.22), 67.79% and 99.88% respectively at pharyngeal site (LR + 554.89, LR- 0.32). 95.95% of MSM reported to be willing to wait for POCT results and no provider reported difficulties in terms of performance or interpretation of the results of the Xpert CT/NG. CONCLUSION: Rapid turnaround time, ease of use and high acceptability make the Xpert CT/NG testing system a strategic tool for increasing testing frequency, reaching those not yet tested and offering the possibility of immediate treatment if needed. The assay showed good negative likelihood ratios and confirms its use to rule out CT/NG infections. Sensitivity varied across sites and pathogens. Periodic staff training at the testing sites should be mandatory.


Assuntos
Infecções por Chlamydia , Gonorreia , Minorias Sexuais e de Gênero , Masculino , Humanos , Homossexualidade Masculina , Neisseria gonorrhoeae/genética , Infecções por Chlamydia/diagnóstico , Infecções por Chlamydia/epidemiologia , Gonorreia/diagnóstico , Gonorreia/epidemiologia , Chlamydia trachomatis/genética , Técnicas de Amplificação de Ácido Nucleico , Tomografia Computadorizada por Raios X
3.
BMC Infect Dis ; 24(Suppl 1): 203, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38418947

RESUMO

BACKGROUND: Sexually transmitted infections caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) remain significant global health problems. The World Health Organization (WHO) has recently conducted a multi-faceted, multi-country validation study (ProSPeRo), which included an evaluation of the Xpert CT/NG and Xpert TV assays on the GeneXpert system (Cepheid, Sunnyvale, Ca., USA) in clinic-based settings across eight countries. To support the study, a training and quality management system was implemented and evaluated. METHODS: A comprehensive training program for the study was developed. Quality control (QC) and external quality assessment (EQA) samples were provided by an accredited quality assurance provider. QC testing was conducted at 14 point-of-care testing (POCT) clinics, while EQA samples were tested by the POCT sites and a reference laboratory supporting each clinic. RESULTS: For QC testing, concordance with the expected results for CT and NG was > 99% and rates of unsuccessful tests were < 4%. For TV testing, concordance was similar (97%), but rates of unsuccessful tests were high (18%), particularly in the 'TV negative' sample. For EQA testing initially conducted in 2018, concordance was 100% for CT and NG, and 90% for TV for the reference laboratory group (which used non-GeneXpert systems). Concordance for the POCT group was also high (> 94%) for all analytes, but this cohort (which used GeneXpert systems) exhibited a high rate of unsuccessful TV tests. All but one of these unsuccessful tests was subcategorised as 'invalid'. CONCLUSIONS: The high level of concordance for QC and EQA testing confirm that the trained operators at the POC clinical sites were competent to conduct POC testing and that the training and quality systems implemented for the ProSPeRo study were effective. The quality materials used were satisfactory for CT and NG but exhibited poor performance for TV testing on the GeneXpert system. The WHO should continue to work with industry and EQA providers to provide improved materials that are reliable, stable and cost effective for quality management, as it seeks to rollout molecular-based STI POCT in non-laboratory-based settings. TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee.


Assuntos
Infecções por Chlamydia , Gonorreia , Infecções Sexualmente Transmissíveis , Trichomonas vaginalis , Humanos , Trichomonas vaginalis/genética , Neisseria gonorrhoeae/genética , Chlamydia trachomatis/genética , Gonorreia/diagnóstico , Infecções por Chlamydia/diagnóstico , Infecções Sexualmente Transmissíveis/diagnóstico , Testes Imediatos
4.
BMC Infect Dis ; 24(Suppl 1): 194, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38418989

RESUMO

BACKGROUND: Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries. METHODS: HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated. RESULTS: Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing. CONCLUSIONS: Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.


Assuntos
Infecções por HIV , HIV-1 , Sífilis , Humanos , Treponema pallidum , Anticorpos Anti-HIV , Infecções por HIV/diagnóstico , Sensibilidade e Especificidade , Anticorpos Antibacterianos , Testes Imediatos , Sorodiagnóstico da Sífilis/métodos , HIV-2 , Organização Mundial da Saúde , Sistemas Automatizados de Assistência Junto ao Leito
5.
BMC Infect Dis ; 24(Suppl 1): 192, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38418941

RESUMO

INTRODUCTION: Globally, the incidence of HIV and syphilis can be reduced by the use of validated point of care tests (POCTs). As part of the WHO PRoSPeRo Network, we aimed to evaluate the performance, acceptability, and operational characteristics of two dual HIV/syphilis POCTs (Bioline HIV/Syphilis Duo (Abbott) and DPP® HIV-Syphilis assay (Chembio) for the screening of HIV and syphilis amongst men who have sex with men (MSM). METHOD AND ANALYSES: A cross sectional study of 2,577 MSM in Italy, Malta, Peru, and the United Kingdom (UK) presenting to seven clinic sites, were enrolled. Finger prick blood was collected to perform POCTs and results compared with standard laboratory investigations on venepuncture blood. Acceptability and operational characteristics were assessed using questionnaires. Diagnostic meta-analysis was used to combine data from the evaluation sites. RESULTS: Based on laboratory tests, 23.46% (n = 598/2549) of participants were confirmed HIV positive, and 35.88% of participants (n = 901/2511) were positive on treponemal reference testing. Of all participants showing evidence of antibodies to Treponema pallidum, 50.56% (n = 455/900) were Rapid Plasma Reagin (RPR) test reactive. Of HIV positive individuals, 60.62% (n = 354/584) had evidence of antibodies to T. pallidum, and of these 60.45% (n = 214/354) exhibited reactive RPR tests indicating probable (co)infection. For Bioline POCT, pooled sensitivities and specificities for HIV were 98.95% and 99.89% respectively, and for syphilis were 73.79% and 99.57%. For Chembio pooled sensitivities and specificities for HIV were 98.66% and 99.55%, and for syphilis were 78.60% and 99.48%. Both tests can detect greater than 90% of probable active syphilis cases, as defined by reactive RPR and treponemal test results. These dual POCTs were preferred by 74.77% (n = 1,926) of participants, due to their convenience, and the operational characteristics made them acceptable to health care providers (HCPs). CONCLUSIONS: Both the Bioline and the Chembio dual POCT for syphilis and HIV had acceptable performance, acceptability and operational characteristics amongst MSM in the PRoSPeRo network. These dual POCTs could serve as a strategic, more cost effective, patient and healthcare provider (HCP) friendly alternative to conventional testing; in clinical and other field settings, especially those in resource-limited settings.


Assuntos
Infecções por HIV , Minorias Sexuais e de Gênero , Sífilis , Masculino , Humanos , Sífilis/diagnóstico , Sífilis/epidemiologia , Homossexualidade Masculina , Peru/epidemiologia , Malta , Estudos Transversais , Treponema pallidum , Testes Imediatos , Sorodiagnóstico da Sífilis/métodos , Sensibilidade e Especificidade , Anticorpos Antibacterianos , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia
6.
Dermatol Ther ; 35(3): e14718, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-33368850

RESUMO

Psoriasis has been reported to be rare in people with skin of color. However, the actual prevalence is probably underestimated by the lack of wide epidemiological studies. The aim of the study is to present our experience in Tigray, Ethiopia, focusing on the issues related to diagnosis, clinical features and therapies. A total of 1288 people affected by psoriasis were visited and 954 were included in a retrospective analysis through the review of medical records of patients attending at three Dermatologic Centers in Ethiopia from 2005 to 2016. The most common clinical form is plaque psoriasis (62.9%), followed by guttate (13.9%), pustular (9.5%), inverse (7.5%), and erythrodermic (6.1%) ones. The prevalence of psoriatic arthritis is 17%. It is often diagnosed late resulting in particularly deforming and debilitating disease. Patients with severe psoriasis often require hospitalization due to the reduced availability of effective treatments and appropriate skin care, resulting in a prolonged recurrence rate or decreased disease-free interval. In poorer rural areas, patients use some traditional African plants such as Kigelia africana which have been shown to have partial benefits in the treatment of psoriasis. Unfortunately, the only available conventional therapies are topical steroids, salicylic acid, methotrexate, and the sun. More studies concerning the appropriate management of people with psoriasis in low income countries, including standardization of indigenous therapies and a reduction of costs of conventional drugs, could help the care of people with psoriasis.


Assuntos
Artrite Psoriásica , Psoríase , Etiópia/epidemiologia , Humanos , Metotrexato/uso terapêutico , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Psoríase/epidemiologia , Estudos Retrospectivos
7.
Trop Med Int Health ; 26(5): 602-606, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33471432

RESUMO

The prevalence of dermatological disease and skin conditions is a significant issue facing refugees and migrants in the WHO European Region. Displaced populations in particular are vulnerable to dermatological diseases, due to the often poor conditions in which they live and transit through at different stages of their journey. Exposure to adverse weather conditions and heightened risk for injuries and violence are also potential causes for skin conditions and abnormalities. Through a review of published literature focusing on refugee and migrant health, this paper outlines the prevalence of skin conditions and dermatological diseases among these populations, and the impact of migration and displacement on susceptibility for them. It then discusses some of the challenges associated with managing skin conditions and highlights key opportunities to strengthen the integration of skin health within health care for migrants and refugees in the WHO European Region.


Assuntos
Refugiados/estatística & dados numéricos , Dermatopatias/epidemiologia , Migrantes/estatística & dados numéricos , Europa (Continente)/epidemiologia , Humanos , Populações Vulneráveis/estatística & dados numéricos , Organização Mundial da Saúde
11.
Ethn Health ; 23(6): 649-658, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-28277022

RESUMO

OBJECTIVES: Dark-skinned people have a lower incidence rate of skin cancer, in particular melanoma, which is detected at more advanced stages leading to poorer prognoses and long-term outcomes compared to whites. The gap in survival is due to some difficulty in melanoma detection, lack of attention from doctors and awareness by patients. This study aims to assess skin cancer risk awareness in dark-skinned immigrants and to determine the influence of socioeconomic factors and ethnic origin on behaviors. DESIGN: This is a cross-sectional health facility based study carried out in a 12-month period. A semi-structured questionnaire to assess skin cancer risk awareness and a dermatological examination was offered to dark-skinned immigrants consecutively attending the dermatology department of the National Institute for Health, Migration and Poverty in Rome. RESULTS: 147 dark-skinned immigrants were enrolled, of which 54.4% were males, coming from Africa (53.1%). They were mainly young, aged 18-34 (56.5%). The level of education and length of stay in Italy was significantly related to the awareness about skin cancer: people with a high educational level (OR: 8.1 95% CI: 3.2-23.4) or immigrated more than 4 years before the interview (OR: 2.1 95% CI: 1.0-4.4) have a greater knowledge about skin cancer. CONCLUSIONS: Education level is the strongest predictive factor of skin cancer awareness, whereas cultural behaviours and personal experience of sunburns are the main factors determining sunlight avoidance. Health promotion programs targeting immigrants must consider cultural differences related to ethnicity and country of origin, and adopt a transcultural approach.


Assuntos
Emigrantes e Imigrantes , Etnicidade , Medição de Risco , Neoplasias Cutâneas/etnologia , Adolescente , Adulto , África/etnologia , Ásia/etnologia , Estudos Transversais , Feminino , Humanos , Itália/epidemiologia , Masculino , Pobreza , Neoplasias Cutâneas/epidemiologia , Fatores Socioeconômicos , Inquéritos e Questionários , Adulto Jovem
12.
Euro Surveill ; 23(43)2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30376912

RESUMO

From 1 January to 30 June 2018, 11 cases of Lymphogranuloma venereum (LGV; all preserved samples (n = 4) genovar L2b) were identified at the Genitourinary Clinic (GUC), Mater Dei Hospital, Msida, Malta. All cases were diagnosed in men who have sex with men (MSM); six participated in three group-sex parties. Here, we describe the outbreak and risk factors associated with LGV diagnoses in MSM in Malta in 2018.


Assuntos
Chlamydia trachomatis/isolamento & purificação , Coinfecção/diagnóstico , Surtos de Doenças , Homossexualidade Masculina , Linfogranuloma Venéreo/diagnóstico , Adulto , Chlamydia trachomatis/genética , Busca de Comunicante , Gonorreia/diagnóstico , Infecções por HIV/diagnóstico , Humanos , Linfogranuloma Venéreo/epidemiologia , Masculino , Malta/epidemiologia , Técnicas de Amplificação de Ácido Nucleico , Fatores de Risco
14.
J Public Health (Oxf) ; 36(3): 368-74, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24277779

RESUMO

BACKGROUND: Over recent years Malta has experienced a growing influx of migrants from Africa. With the aim of defining demographic characteristics and assessing the prevalence of conditions of public health significance among asylum seekers in Malta, a clinical research study was implemented in the framework of the European Union project 'Mare nostrum'. METHODS: From August 2010 to June 2011 a dermatologist and an infectious diseases specialist performed general and specialist health assessment of migrants hosted in open centres. RESULTS: Migrants included in the study were 2216, 82.7% were males, their mean age was 25 years and 70.1% were from Somalia. Out of the total females, 42.5% had undergone some type of Female Genital Mutilation/Cutting. A total of 5077 diagnoses were set, most common were skin diseases (21.9%), respiratory diseases (19.8%) and gastro-enteric diseases (14.2%), whereas 31% of migrants reported good health conditions. CONCLUSIONS: Immigrants have a lower morbidity burden compared with their fellow countrymen living in the origin country. However, living conditions during the journey, in transit countries and after arrival can influence their health status. The present study provides a comprehensive picture of this growing population that is in need for health promotion, mental health services and fair policy planning.


Assuntos
Determinantes Sociais da Saúde/estatística & dados numéricos , Migrantes/estatística & dados numéricos , Adolescente , Adulto , Criança , Pré-Escolar , Feminino , Nível de Saúde , Humanos , Lactente , Recém-Nascido , Masculino , Malta/epidemiologia , Pessoa de Meia-Idade , Estudos Retrospectivos , Somália/etnologia , Adulto Jovem
15.
Int J STD AIDS ; : 9564624241282423, 2024 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-39266458

RESUMO

Syphilis is often referred to as the 'great imitator' due to its diverse clinical manifestations throughout its clinical stages and polymorphic nature. We report a case of a 24-year-old man-who-has-sex-with-men presenting with an atypical syphilitic rash on the trunk, with a corymbiform appearance. This case highlights the necessity for clinicians to maintain a high index of suspicion for sexually transmitted infections, especially when there are skin manifestations of an uncertain nature.

16.
Int J STD AIDS ; 35(9): 742-745, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38695071

RESUMO

Neisseria gonorrhoeae (Ng) is a major cause of morbidity among sexually active individuals, occasionally leading to serious complications if left untreated. We describe a case of gonococcal peritonitis as a rare complication of Ng infection in a woman presenting with acute abdomen and intestinal subacute occlusion. Due to the rarity of this clinical presentation, we review the scientific literature to identify best practices and inform guidelines.


Assuntos
Antibacterianos , Gonorreia , Neisseria gonorrhoeae , Peritonite , Humanos , Gonorreia/diagnóstico , Gonorreia/tratamento farmacológico , Gonorreia/complicações , Gonorreia/microbiologia , Peritonite/microbiologia , Peritonite/tratamento farmacológico , Peritonite/diagnóstico , Feminino , Neisseria gonorrhoeae/isolamento & purificação , Antibacterianos/uso terapêutico , Adulto , Resultado do Tratamento , Ceftriaxona/uso terapêutico
17.
BMJ Open ; 14(6): e073565, 2024 Jun 16.
Artigo em Inglês | MEDLINE | ID: mdl-38885995

RESUMO

INTRODUCTION: In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoniasis (Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with 'gold-standard' reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries. METHOD AND ANALYSES: Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer's instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022. ETHICS AND DISSEMINATION: Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences.


Assuntos
Infecções por Chlamydia , Gonorreia , Homossexualidade Masculina , Testes Imediatos , Humanos , Masculino , Feminino , Infecções por Chlamydia/diagnóstico , Gonorreia/diagnóstico , Estudos Prospectivos , Programas de Rastreamento/métodos , Trichomonas vaginalis/isolamento & purificação , Infecções Sexualmente Transmissíveis/diagnóstico , Vaginite por Trichomonas/diagnóstico , Vaginite por Trichomonas/epidemiologia , Estudos Multicêntricos como Assunto , Sensibilidade e Especificidade , Adulto , Sistemas Automatizados de Assistência Junto ao Leito
18.
Int J Dermatol ; 62(10): 1266-1271, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37592818

RESUMO

BACKGROUND: In May of 2022, an mpox (formerly known as monkeypox) outbreak was reported from countries where the disease is not endemic, rising worldwide concern. Malta, the smallest European Union member state, faced unique challenges, with high infection rates compared to the rest of Europe. The aim of the study is to describe the clinical characteristics, diagnostic challenges, and unique demographics of mpox patients diagnosed in Malta. METHODS: This is a retrospective analysis of medical records of all mpox cases recorded from May to September 2022. Demographic data, sexual behaviors and practices, travel history, comorbidities, and HIV status were investigated. RESULTS: In the study period, we recorded 33 mpox cases, 97% of them were male, in the age group 30-39 (39%). Ninety percent were gay or bisexual men and 76% non-Maltese. The most common clinical presentations included skin rash (78%), lymphadenopathy (71%), anogenital lesions (67%), and fever (67%). Twenty-seven percent of the patients were people living with HIV. In terms of coinfection with STIs, 27% of patients tested positive for gonorrhea, 12% for syphilis, 15% for chlamydia, 9% for herpes simplex virus, and 3% for hepatitis C virus. CONCLUSION: The results shed light on unique challenges faced by the local sexual health clinic and call for more resources in response to the global emerging of infectious diseases.


Assuntos
Infecções por HIV , Mpox , Humanos , Masculino , Feminino , Malta/epidemiologia , Estudos Retrospectivos , Surtos de Doenças , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia
19.
Front Microbiol ; 14: 1130762, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36910203

RESUMO

The prevalence of Mycoplasma genitalium (MG) and MG antimicrobial resistance (AMR) appear to be high internationally, however, prevalence data remain lacking globally. We evaluated the prevalence of MG and MG AMR-associated mutations in men who have sex with men (MSM) in Malta and Peru and women at-risk for sexually transmitted infections in Guatemala, South Africa, and Morocco; five countries in four WHO regions mostly lacking MG prevalence and AMR data, and estimated MG coinfections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Male urine and anorectal samples, and vaginal samples were tested for MG, CT, NG, and TV (only vaginal samples) using Aptima assays (Hologic). AMR-associated mutations in the MG 23S rRNA gene and parC gene were identified using ResistancePlus MG kit (SpeeDx) or Sanger sequencing. In total, 1,425 MSM and 1,398 women at-risk were recruited. MG was detected in 14.7% of MSM (10.0% in Malta and 20.0% Peru) and in 19.1% of women at-risk (12.4% in Guatemala, 16.0% Morocco, 22.1% South Africa). The prevalence of 23S rRNA and parC mutations among MSM was 68.1 and 29.0% (Malta), and 65.9 and 5.6% (Peru), respectively. Among women at-risk, 23S rRNA and parC mutations were revealed in 4.8 and 0% (Guatemala), 11.6 and 6.7% (Morocco), and 2.4 and 3.7% (South Africa), respectively. CT was the most frequent single coinfection with MG (in 2.6% of MSM and 4.5% of women at-risk), compared to NG + MG found in 1.3 and 1.0%, respectively, and TV + MG detected in 2.8% of women at-risk. In conclusion, MG is prevalent worldwide and enhanced aetiological MG diagnosis, linked to clinical routine detection of 23S rRNA mutations, in symptomatic patients should be implemented, where feasible. Surveillance of MG AMR and treatment outcome would be exceedingly valuable, nationally and internationally. High levels of AMR in MSM support avoiding screening for and treatment of MG in asymptomatic MSM and general population. Ultimately, novel therapeutic antimicrobials and/or strategies, such as resistance-guided sequential therapy, and ideally an effective MG vaccine are essential.

20.
Lancet Reg Health Eur ; 34: 100742, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37927427

RESUMO

In this scoping review, we offer a comprehensive understanding of the current and recent epidemiology, challenges, and emerging issues related to bacterial sexually transmitted infections (STIs) in the WHO European Region. We endeavour in collating data from both EU/EEA and non- EU/EEA countries, thereby giving a complete picture of the region which highlights the higher notification rates in Northern and Western countries than other regions, likely due to differences in testing, access to testing, and surveillance capacity. We provide an up-to-date review on the current knowledge of determinants and persistent inequities in key populations as well as the use of molecular epidemiology for identifying transmission networks in gonorrhoea and syphilis, and detecting chlamydia mutations that evade molecular diagnosis. Finally, we explore the emerging STIs in the region and the evolving transmission routes of food and waterborne diseases into sexual transmission. Our findings call for harmonized STI surveillance systems, proactive strategies, and policies to address social factors, and staying vigilant for emerging STIs.

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