• 文章类型: Journal Article
    澳大利亚国家奈瑟菌网络(NNN)包括每个州和地区的参考实验室,这些参考实验室向澳大利亚淋球菌监测计划(AGSP)商定的一组抗菌药物报告抗菌药物敏感性试验数据。AGSP数据每季度以表格形式显示,以及在AGSP年度报告中。本报告提供了2023年10月1日至12月31日的国家淋球菌抗菌素耐药性监测数据。
    UNASSIGNED: The Australian National Neisseria Network (NNN) comprises reference laboratories in each state and territory that report data on antimicrobial susceptibility testing to an agreed group of antimicrobial agents for the Australian Gonococcal Surveillance Programme (AGSP). The AGSP data are presented quarterly in tabulated form, as well as in the AGSP annual report. This report presents national gonococcal antimicrobial resistance surveillance data from 1 October to 31 December 2023.
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  • 文章类型: Journal Article
    目的:本研究旨在验证和实施一种快速筛查方法,用于检测淋病奈瑟菌中与头孢曲松耐药相关的penA-60等位基因,用于分离裂解物和临床标本DNA提取物。
    方法:淋病奈瑟菌penA实时(RT)-PCR适用于包括物种特异性pap确认靶标和市售内部对照以监测PCR抑制。使用淋病奈瑟菌阳性(n=24)和淋病奈瑟菌阴性(n=42)临床标本和分离裂解物来验证修改的测定。该小组包括七个具有由该测定靶向的penA等位基因赋予的抗性的样品和四个具有不同penA等位基因的样品。使用来自伦敦性健康诊所的54名患者的临床标本评估了使用penART-PCR进行分子监测的可行性,这些患者也有2020年淋病奈瑟菌耐药性监测计划(GRASP)中包括的淋病奈瑟菌分离株。
    结果:该测定正确地鉴定了淋病奈瑟氏球菌标本(n=7),其具有该测定靶向的penA-60/64等位基因。没有检测到pena假阴性/阳性,赋予测定的PIA目标灵敏度,特异性,正负预测值(PPV,净现值)为100%(95%CI;灵敏度;56.1-100%,特异性;93.6-100%,PPV;56.1-100%,净现值;93.6-100%)。未检测到与其他奈瑟球菌或其他泌尿生殖道病原体的交叉反应性。在78份淋病奈瑟菌阳性标本中,有73份检测到淋病奈瑟菌目标(pap),产生92.6%的灵敏度(95%CI83.0%至97.3%),100%特异性(95%CI75.9%至100%)和PPV,净现值为89.4%(95%CI为52.5%至90.9%)。在GRASP2020可行性分子监测研究的临床标本中未检测到penA-59/60/64等位基因(n=54个个体)。
    结论:实施此PCR检测用于患者管理,公共卫生和监视目的可以快速检测最广泛流行的penA等位基因赋予的淋球菌头孢曲松耐药性。
    OBJECTIVE: This study aimed to validate and implement a rapid screening assay for molecular detection of the penA-60 allele that is associated with ceftriaxone resistance in Neisseria gonorrhoeae for use on both isolate lysates and clinical specimen DNA extracts.
    METHODS: A N. gonorrhoeae penA real-time (RT)-PCR was adapted to include a species-specific pap confirmation target and a commercially available internal control to monitor for PCR inhibition.The modified assay was validated using N. gonorrhoeae-positive (n=24) and N. gonorrhoeae-negative (n=42) clinical specimens and isolate lysates. The panel included seven samples with resistance conferred by penA alleles targeted by the assay and four samples with different penA alleles. The feasibility of using the penA RT-PCR for molecular surveillance was assessed using clinical specimens from 54 individuals attending a London sexual health clinic who also had a N. gonorrhoeae isolate included in the 2020 Gonococcal Resistance to Antimicrobials Surveillance Programme (GRASP).
    RESULTS: The assay correctly identified N. gonorrhoeae specimens (n=7) with penA-60/64 alleles targeted by the assay. No penA false negatives/positives were detected, giving the penA target of the assay a sensitivity, specificity, positive and negative predicted values (PPV, NPV) of 100% (95% CIs; sensitivity; 56.1-100%, specificity; 93.6-100%, PPV; 56.1-100%, NPV; 93.6-100%).No cross-reactivity with other Neisseria species or other urogenital pathogens was detected. The N. gonorrhoeae target (pap) was detected in 73 out of 78 of the N. gonorrhoeae-positive specimens, resulting in 92.6% sensitivity (95% CI 83.0% to 97.3%), 100% specificity (95% CI 75.9% to 100%) and PPV, and a NPV of 89.4% (95% CI 52.5% to 90.9%). No penA-59/60/64 alleles were detected within the clinical specimens from the GRASP 2020 feasibility molecular surveillance study (n=54 individuals).
    CONCLUSIONS: The implementation of this PCR assay for patient management, public health and surveillance purposes enables the rapid detection of gonococcal ceftriaxone resistance conferred by the most widely circulating penA alleles.
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  • 文章类型: Case Reports
    淋病奈瑟氏球菌(NG)的耐药性是一个日益增加的公共卫生问题,世卫组织将淋球菌视为“高度优先”病原体,以研究和开发新的治疗方案。根据欧洲疾病预防和控制中心(ECDC)2022年的数据,NG感染率是自2009年欧洲开始对性传播感染进行监测以来的最高记录。我们报告了感染两种不同的耐药淋病奈瑟菌分离株的患者的简要描述。淋病奈瑟菌的口咽部和尿道拭子培养阳性,分离株对抗菌药物的敏感性不同。我们调查了这些分离株对六种抗菌剂(头孢曲松,头孢克肟,阿奇霉素,环丙沙星,四环素,和苄青霉素),和最小抑制浓度(MIC;mg/L)使用Etest对淋球菌分离株进行测定。口咽分离株对阿奇霉素耐药,尿道对青霉素耐药,环丙沙星,还有四环素.鉴定了两种不同的和系统发育上不同的NG分离物序列类型。了解耐药性传播的动态和驱动因素可以为抗生素管理提供改进的理由。应密切监测NG电阻的水平。
    The antimicrobial resistance of Neisseria gonorrhoeae (NG) is an increasing public health concern, highlighted by the fact that gonococcus is considered as a \'high\'-priority pathogen by the WHO for research and development of new therapeutic options. According to the data of the European Centre for Disease Prevention and Control (ECDC) in 2022, the rate of NG infections is the highest recorded since European surveillance of sexually transmitted infections began in 2009. We report a brief description of a patient infected with two different isolates of drug-resistant N. gonorrhoeae. N. gonorrhoeae cultures were positive from oropharyngeal and urethral swabs and isolates had different antimicrobial susceptibility. We investigated the antimicrobial susceptibility of these isolates to six antimicrobials (ceftriaxone, cefixime, azithromycin, ciprofloxacin, tetracycline, and benzylpenicillin), and minimum inhibitory concentrations (MICs; mg/L) were determined using Etest on gonococcal isolates. Oropharyngeal isolate was resistant to azithromycin while urethral was resistant to penicillin, ciprofloxacin, and tetracycline. Two different and phylogenetically distinct sequence types of NG isolates were identified. Understanding the dynamics and drivers of resistance spread can provide an improved rationale for antibiotic management, and the level of NG resistance should be monitored closely.
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  • 文章类型: Journal Article
    为了确定淋病奈瑟菌的抗菌药物敏感性,我们分析了2023年在柬埔寨收集的72个分离株的表型和基因组.其中,9/72(12.5%)广泛耐药,比2022年增加3倍。基因组分析证实了新出现的抗性克隆的扩展和新的系统发育骨干的持续抗性出现。
    To determine antimicrobial susceptibility of Neisseria gonorrhoeae, we analyzed phenotypes and genomes of 72 isolates collected in Cambodia in 2023. Of those, 9/72 (12.5%) were extensively drug resistant, a 3-fold increase from 2022. Genomic analysis confirmed expansion of newly emerging resistant clones and ongoing resistance emergence across new phylogenetic backbones.
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  • 文章类型: Journal Article
    背景:虽然酒精和危险行为之间的联系是众所周知的,酒精滥用和感染性传播感染(STIs)之间的明确相关性尚未确定.由4个问题组成的CAGE问卷-首字母缩写代表与酒精使用有关的态度和活动-通常在初级保健年度就诊时进行,以筛查患者是否存在酒精滥用。这项研究评估了CAGE评分与STI结果之间的关系,以确定CAGE问卷是否可以帮助确定每年访视时是否需要进行STI筛查。方法:将2015年至2022年在海湾南部卫生系统接受CAGE筛查的所有患者纳入分析。该研究的主要结果是CAGE评分阳性(评分≥2)与STI结果阳性之间的关系。主要分析中包括的性传播感染是人类免疫缺陷病毒(HIV),乙型肝炎,梅毒,衣原体,淋病,和滴虫病。CAGE评分阳性与丙型肝炎之间的相关性被视为次要结果。结果:在研究期间,共有40,022名患者接受了CAGE筛查,757(1.9%)在CAGE问卷中得分≥2。发现CAGE评分阳性与乙型肝炎之间存在显着关联(比值比[OR]=2.69,95%CI1.91,3.80;P<0.001),淋病(OR=5.43,95%CI1.80,16.39;P=0.003),和丙型肝炎(OR=2.10,95%CI1.57,2.80;P<0.001)。CAGE评分阳性与HIV之间没有发现关联,衣原体,或滴虫病。没有CAGE评分≥2的患者诊断为梅毒;因此,不可能进行梅毒分析.结论:根据本研究的结果,CAGE评分≥2的患者可能受益于乙型肝炎筛查,丙型肝炎,和淋病在他们的初级保健年度访问。早期的STI检测可以导致及时的治疗并防止进一步的传播和并发症。
    Background: While the connection between alcohol and risky behavior is well known, a clear correlation between alcohol misuse and contracting sexually transmitted infections (STIs) has not been determined. The 4-question CAGE questionnaire-the acronym stands for attitudes and activities related to alcohol use-is often administered at primary care annual visits to screen patients for alcohol abuse. This study assessed the relationship between CAGE scores and STI results to determine if the CAGE questionnaire could help determine the need for STI screening at annual visits. Methods: All patients who received a CAGE screening from 2015 to 2022 at a Gulf South health system were included in the analysis. The primary outcome of the study was the relationship between a positive CAGE score (a score ≥2) and a positive STI result. STIs included in the primary analysis were human immunodeficiency virus (HIV), hepatitis B, syphilis, chlamydia, gonorrhea, and trichomoniasis. The correlation between a positive CAGE score and hepatitis C was examined as a secondary outcome. Results: A total of 40,022 patients received a CAGE screening during the study period, and 757 (1.9%) scored ≥2 on the CAGE questionnaire. Significant associations were found between a positive CAGE score and hepatitis B (odds ratio [OR]=2.69, 95% CI 1.91, 3.80; P<0.001), gonorrhea (OR=5.43, 95% CI 1.80, 16.39; P=0.003), and hepatitis C (OR=2.10, 95% CI 1.57, 2.80; P<0.001). No associations were found between a positive CAGE score and HIV, chlamydia, or trichomoniasis. No patients with a CAGE score ≥2 had a syphilis diagnosis; therefore, no syphilis analysis was possible. Conclusion: Based on the results of this study, patients with a CAGE score ≥2 may benefit from screening for hepatitis B, hepatitis C, and gonorrhea at their primary care annual visit. Early STI detection could lead to prompt treatment and prevent further transmission and complications.
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    文章类型: English Abstract
    目的:评估卡拉地区育龄妇女中4种性传播感染的患病率。
    方法:2022年3月进行了一项横断面研究。使用标准化问卷收集数据。使用SD-BIOLINEHIV/梅毒Duo&#174;快速测试进行HIV和梅毒的筛查。使用GeneXpertPCR技术检测沙眼衣原体和淋病奈瑟菌。性传播感染(沙眼衣原体,淋病奈瑟菌,梅毒螺旋体,和HIV)以95%置信区间报告。
    结果:共纳入300名女性,中位年龄为32岁(四分位距24&#8211;39)。其中,在过去的12个月中,有25.7%的人咨询过妇科医生。沙眼衣原体的患病率为4.3%(95%CI[2.4&#8211;7.5]);淋病奈瑟菌3.3%[95%CI:1.7&#8211;6.2],梅毒螺旋体0.3%[95%CI:0.02–2.1]和HIV3.7%[95%CI:1.9–6.7]。报告了3例淋病奈瑟菌和沙眼衣原体共同感染;没有报告与HIV和细菌性性传播感染共同感染的病例。
    结论:这项研究证实了女性获得妇科咨询的机会有限,梅毒的低循环,以及卡拉地区育龄女性中淋病奈瑟菌和沙眼衣原体的存在。需要一个性传播感染监测系统来改善这一人群的性传播感染管理。
    OBJECTIVE: To estimate the prevalence of four STIs in women of reproductive age in the Kara region.
    METHODS: A cross-sectional study was conducted in March 2022. Data were collected using a standardized questionnaire. Screening for HIV and syphilis was performed using the SD-BIOLINE HIV/Syphilis Duo® rapid tests. The GeneXpert PCR technique was used to test for Chlamydia trachomatis and Neisseria gonorrhoeae. The prevalences of STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, and HIV) were reported with 95% confidence intervals.
    RESULTS: A total of 300 women with a median age of 32 years (interquartile range 24–39) were included. Of these, 25.7% had consulted a gynecologist in the last twelve months. The prevalence of Chlamydia trachomatis was 4.3% (95% CI [2.4–7.5]); Neisseria gonorrhoeae 3.3% [95% CI: 1.7–6.2], Treponema pallidum 0.3% [95% CI: 0.02–2.1] and HIV 3.7% [95% CI: 1.9–6.7]. Three cases of co-infection with Neisseria gonorrhoeae and Chlamydia trachomatis were reported; no cases of co-infection with HIV and bacterial STIs were reported.
    CONCLUSIONS: This study confirms the women’s limited access to gynecological consultations, the low circulation of syphilis, and the presence of Neisseria gonorrhoeae and Chlamydia trachomatis in women of reproductive age in the Kara region. An STI surveillance system is needed to improve STI management among this population.
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  • 文章类型: Journal Article
    Despite significant research on the prevalence of STIs in South African men who have sex with men (MSM), recent data on the prevalence and risk factors for curable STI infections among this key populations are limited. This study determined the prevalence of and risk factors associated with Neisseria gonorrhoeae and Chlamydia trachomatis infections among MSM. The sample consisted of 200 MSM resident in Durban. Data were collected using a self-administered questionnaire, and urine samples were collected and tested for N. gonorrhoeae and C. trachomatis. The prevalence of N. gonorrhoeae and C. trachomatis were 3.0% and 6.0%, respectively. Younger age was significantly associated with testing positive for C. trachomatis (p=0.037). Being between the ages of 30-39 years old reduced the risk of acquiring C. trachomatis infection (OR: 0.10, 95% CI: 0.0120-0.7564, p=0.026). In addition, being circumcised reduced the risk of contracting C. trachomatis (adjusted OR: 0.01, 95% CI: 0.0005-0.3516, p=0.01). However, having between 2-4 sex partners increased the risk of testing positive for C. trachomatis (adjusted OR: 107.45, 95% CI: 1.3467-8573.3130, p=0.036). The following factors were significantly associated (p<0.05) with testing positive for N. gonorrhoeae infection: cohabiting with sex partner, engaging in group sex, and drug use. Fear and stigma were the main barriers to accessing health care in the studied population. This study provided evidence of high rates of C. trachomatis infection among MSM resident in Durban. Based on the results, South African MSM, especially the young MSM population, should be given priority when delivering intervention programs to prevent STIs.
    Malgré des recherches importantes sur la prévalence des IST chez les hommes sud-africains ayant des rapports sexuels avec des hommes (HSH), les données récentes sur la prévalence et les facteurs de risque d\'infections IST curables parmi ces populations clés sont limitées. Cette étude a déterminé la prévalence et les facteurs de risque associés aux infections à Neisseria gonorrhoeae et à Chlamydia trachomatis chez les HARSAH. L\'échantillon était composé de 200 HSH résidant à Durban. Les données ont été collectées à l\'aide d\'un questionnaire auto-administré et des échantillons d\'urine ont été collectés et testés pour N. gonorrhoeae et C. trachomatis. La prévalence de N. gonorrhoeae et de C. trachomatis était respectivement de 3,0 % et 6,0 %. Un âge plus jeune était significativement associé à un test positif pour C. trachomatis (p = 0,037). Le fait d\'être âgé de 30 à 39 ans réduisait le risque de contracter une infection à C. trachomatis (OR : 0,10, IC à 95 % : 0,0120-0,7564, p = 0,026). De plus, être circoncis réduisait le risque de contracter C. trachomatis (OR ajusté : 0,01, IC à 95 % : 0,0005-0,3516, p=0,01). Cependant, avoir entre 2 et 4 partenaires sexuels augmentait le risque d\'être testé positif pour C. trachomatis (OR ajusté : 107,45, IC à 95 % : 1,3467-8573,3130, p=0,036). Les facteurs suivants étaient significativement associés (p < 0,05) au test positif pour l\'infection à N. gonorrhoeae : cohabitation avec un partenaire sexuel, participation à des relations sexuelles en groupe et consommation de drogues. La peur et la stigmatisation étaient les principaux obstacles à l\'accès aux soins de santé dans la population étudiée. Cette étude a mis en évidence des taux élevés d\'infection à C. trachomatis parmi les HSH résidant à Durban. Sur la base des résultats, les HSH sud-africains, en particulier la jeune population HSH, devraient être prioritaires lors de la mise en œuvre de programmes d\'intervention visant à prévenir les IST.
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  • 文章类型: Journal Article
    背景:成人淋病奈瑟菌感染通常会导致阴道炎和急性尿道炎,新生儿通过产道感染可导致急性新生儿结膜炎。鉴于染色显微镜法淋病奈瑟菌漏检率高等因素,细菌培养方法耗时且灵敏度有限,复杂,无法从普通的PCR方法进行绝对定量。
    方法:本研究旨在建立ddPCR系统,以绝对定量检测淋病奈瑟菌,高特异性,高稳定性和准确的方式。我们选择pgi1基因作为检测淋病奈瑟菌的靶基因。
    结果:在ddPCR反应中扩增效率良好,整个检测过程可在94min内完成。它具有高达5.8pg/μL的高灵敏度。具有很高的特异性,在本实验中,在9种阴性对照病原体中未检测到阳性微滴。此外,ddPCR检测淋病奈瑟菌具有良好的重复性,计算的CV为4.2%。
    结论:DdPCR检测技术具有绝对定量的特点,高稳定性,淋病奈瑟菌的高特异性和高准确性。提高了淋病奈瑟菌检测的准确性,为临床诊断和治疗提供更科学的依据。
    BACKGROUND: Infection with Neisseria gonorrhoeae in adults usually leads to vaginitis and acute urethritis, and infection through the birth canal in newborns can lead to acute neonatal conjunctivitis. In view of certain factors such as a high missed detection rate of N.gonorrhoeae from staining microscopy method, the time-consuming nature and limited sensitivity of bacterial culture method, complicated and inability of absolute quantification from the ordinary PCR method.
    METHODS: This study aims to establish a ddPCR system to detect N.gonorrhoeae in a absolute quantification, high specificity, high stability and accurate way. We selected the pgi1 gene as the target gene for the detection of N.gonorrhoeae.
    RESULTS: The amplification efficiency was good in the ddPCR reaction, and the whole detection process could be completed in 94 min. It has a high sensitivity of up to 5.8 pg/μL. With a high specificity, no positive microdroplets were detected in 9 negative control pathogens in this experiment. In addition, ddPCR detection of N.gonorrhoeae has good repeatability, and the calculated CV is 4.2 %.
    CONCLUSIONS: DdPCR detection technology has the characteristics of absolute quantification, high stability, high specificity and high accuracy of N.gonorrhoeae. It can promote the accuracy of the detecting of N.gonorrhoeae, providing a more scientific basis for clinical diagnosis and treatment.
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  • 文章类型: Journal Article
    淋病奈瑟菌的抗菌素耐药性问题日益严重,因此需要开发适用于快速和大规模筛查的分子分型方案。本研究的目的是根据全球病原体种群数据设计和验证淋病奈瑟菌的微型MLST方案。使用PubMLST数据库中具有已知MLST的21,402个分离株的七个管家基因的序列,我们鉴定了18个提供信息的多态性,并获得了mini-MLST核苷酸谱来预测分离株的MLST.我们提出了一种新的基于mini-MLST谱的淋病奈瑟菌MLST分组系统。系统发育分析表明,MLST基因组是淋病奈瑟菌全球种群的稳定特征。拟议的分组系统已被证明可以将具有相似抗菌敏感性的分离株聚集在一起,主要基因组的特征证明了这一点。基于核苷酸谱的已建立的MLST预测算法现在是公开可用的。使用基于原始水凝胶DNA微阵列的MLST检测/预测方法评估小型MLST方案。结果证实了MLST基因组的高预测能力。拟议的淋球菌种群分析整体方法可用于连续监测已知和新出现的耐药淋病奈瑟菌分离株。
    The increasing problem of antimicrobial resistance in N. gonorrhoeae necessitates the development of molecular typing schemes that are suitable for rapid and mass screening. The objective of this study was to design and validate a mini-MLST scheme for N. gonorrhoeae based on global pathogen population data. Using sequences of seven housekeeping genes of 21,402 isolates with known MLSTs from the PubMLST database, we identified eighteen informative polymorphisms and obtained mini-MLST nucleotide profiles to predict MLSTs of isolates. We proposed a new MLST grouping system for N. gonorrhoeae based on mini-MLST profiles. Phylogenetic analysis revealed that MLST genogroups are a stable characteristic of the N. gonorrhoeae global population. The proposed grouping system has been shown to bring together isolates with similar antimicrobial susceptibility, as demonstrated by the characteristics of major genogroups. Established MLST prediction algorithms based on nucleotide profiles are now publicly available. The mini-MLST scheme was evaluated using a MLST detection/prediction method based on the original hydrogel DNA microarray. The results confirmed a high predictive ability up to the MLST genogroup. The proposed holistic approach to gonococcal population analysis can be used for the continuous surveillance of known and emerging resistant N. gonorrhoeae isolates.
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  • 文章类型: Journal Article
    背景:2016年,世卫组织估计成年人中大约有3.74亿新感染以下四种可治愈的性传播感染(STIs):衣原体(由沙眼衣原体(CT)引起),淋病(淋病奈瑟菌(NG)),梅毒(梅毒螺旋体)和滴虫(阴道毛滴虫(TV))。准确的护理点测试(POCT),用于筛查生殖器和生殖器外CT,NG和TV感染具有很大的价值,并且在最近十年中得到了发展。在基于实验室的研究中,与“黄金标准”参考测试相比,有几种测试在商业上可用,并显示出令人鼓舞的性能。然而,他们的临床表现数据有限,包括POC。重点人群,例如与男性发生性关系的男性(MSM),在生殖器和生殖器外部位有更高的性传播感染风险,并且这些性传播感染通常是无症状的,尤其是在外生殖器部位和女性中。Wewillconductaclinical-basedevaluationtoassessatetheperformancecharacteristicsandacceptabilitytoend-usersofthepoc/nearpatientuseoftheXpertCT/NG(Cepheid,桑尼维尔,加州,美国)生殖器筛查测试,MSM和XpertCT/NG和XpertTV的肛门直肠和咽部CT和NG感染(造父变星,桑尼维尔,加州,美国)用于生殖器CT筛查,与金标准参考核酸扩增测试相比,有这些性传播感染风险的女性的NG和TV。这个主协议概述了将在七个国家使用的总体研究方法。
    方法:连续MSM和在临床地点出现的高危女性,低收入和中等收入国家将被注册。要评估的POCT是XpertCT/NG和XpertTV。所有程序将由训练有素的医护人员执行,并严格按照制造商的说明进行测试。敏感性,特异性,将计算每个POCT的阳性和阴性预测值。该研究正在进行中,预计将于2022年年中至2022年底在所有国家完成招聘。
    背景:在注册之前,本核心方案由世卫组织性健康和生殖健康与研究部研究项目审查小组(RP2)和世卫组织伦理审查委员会(ERC)独立同行评审和批准.核心议定书已根据个别国家和RP2和ERC批准的改编进行了略微调整,以及每个参与地点的所有相关机构审查委员会。结果将通过同行评审的期刊传播,并在相关的国家/国际会议上发表。
    BACKGROUND: 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.
    METHODS: 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.
    BACKGROUND: 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.
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