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Opt-out HIV screening in adults attending the Emergency Department of a London teaching hospital 在伦敦一家教学医院急诊科就诊的成人中选择不接受艾滋病毒筛查。
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-10-08 DOI: 10.1016/j.jcv.2024.105735
Raissa Rachman , Tanzina Haque , Tristan J Barber , Fiona Burns , Jessica Pinto , Alan Hunter , Russell Durkin , Jennifer Hart

Background

Opt-out Emergency Department blood borne virus (EDBBV) screening was introduced at the Royal Free Hospital under the NHSEI (NHS England and NHS Improvement) programme to expand opt-out testing in local authority areas with high HIV prevalence. This initiative was part of the “Toward Zero” policy towards ending HIV transmission in England by 2030.

Methods

All patients attending the Royal Free Hospital Emergency Department (ED) aged 16 and over were screened for blood borne viruses (HIV/HBV/HCV) unless they opted out. We looked at HIV data from patients seen in ED between the initiation of EDBBV testing on the 12th of April and 12th of August 2022. Hepatitis B and C data was reviewed in a separate study.

Outcome

A total of 12,208 samples from 10,641 patients were screened for HIV. Amongst these samples there were 88 which were positive, giving a seroprevalence of 0.84 %. There were 48 patients who were already known to local HIV services, 35 were known to HIV services outside of our Trust and 5 were new diagnoses.

Conclusion

Our results confirmed our local HIV prevalence to be very high, as per the UK Health Security Agency and supports the need for HIV testing. Opt-out ED BBV screening has been a highly effective method for identifying people living with HIV who are unaware of their status.
背景:根据英国国家医疗服务体系(NHSEI)和英国国家医疗服务体系改进(NHS Improvement)计划,皇家自由医院引入了急诊科血液传播病毒(EDBBV)选择性筛查,在艾滋病高发地区扩大选择性检测范围。这一举措是 "迈向零 "政策的一部分,旨在到 2030 年在英格兰杜绝 HIV 传播:所有在皇家自由医院急诊科(ED)就诊的 16 岁及以上患者都要接受血液传播病毒(HIV/HBV/HCV)筛查,除非他们选择不接受筛查。我们研究了自 2022 年 4 月 12 日开始进行 EDBBV 检测至 8 月 12 日期间急诊科就诊患者的 HIV 数据。乙肝和丙肝数据在另一项研究中进行了审查:共对来自 10,641 名患者的 12,208 份样本进行了艾滋病毒筛查。在这些样本中,有 88 份呈阳性,血清阳性率为 0.84%。其中有 48 名患者已在当地的 HIV 服务机构接受过检测,35 名患者在信托基金以外的 HIV 服务机构接受过检测,5 名患者是新诊断出的:我们的结果证实,根据英国卫生安全局的数据,我们当地的 HIV 感染率非常高,因此有必要进行 HIV 检测。选择不接受 ED BBV 筛查是一种非常有效的方法,可以识别不知道自己感染情况的 HIV 感染者。
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引用次数: 0
Metagenomic characterization of viruses in the serum of children with newly diagnosed cancer 新诊断癌症儿童血清中病毒的元基因组特征
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-10-06 DOI: 10.1016/j.jcv.2024.105736
Gustaf Leijonhufvud , Tatiany Aparecida Teixeira Soratto , Gabriel Machado Matos , Amanj Bajalan , Claudia Eichler-Jonsson , Britt Gustafsson , Gordana Bogdanovic , Tobias Allander , Gustaf Ljungman , Björn Andersson

Background and Objectives

A large cohort of pediatric patients with various forms of childhood cancer was investigated for the presence of viruses using metagenomics. A total of 476 patient samples, collected between 1989 and 2018, were analyzed, representing various pediatric oncological diagnoses and a control group of non-malignant diagnoses.

Study design

The study was carried out using metagenomic sequencing of serum samples. Viruses were identified and analyzed using bioinformatics methods, followed by Polymerase chain reaction (PCR) confirmation

Results

The results indicate that a wide range of viruses can be detected in the bloodstream of children with newly diagnosed cancer. Nine viral genomes were identified: Human Pegivirus (HPgV), Hepatitis C virus, Parechovirus 1, Rhinovirus C, Human papillomavirus 116, Human polyomavirus 10, Parvovirus B19, and different variants of Torque Teno Virus (TTV). In this study, a previously unknown virus was found belonging to the Iflavirdae family in the order Picornavirales. HPGV was significantly more common in patients with leukemia compared to other conditions.

Conclusions

These results highlight the abundance of systemic virus infections in children, and the value of metagenomic sequencing for hypothesis forming regarding the associations between virus infections and cancer.
背景与目的研究人员利用元基因组学方法对患有各种形式儿童癌症的大量儿科患者进行了调查,以确定是否存在病毒。共分析了 1989 年至 2018 年间收集的 476 份患者样本,这些样本代表了各种儿科肿瘤诊断和非恶性诊断对照组。结果结果表明,在新诊断癌症患儿的血液中可以检测到多种病毒。共鉴定出九种病毒基因组:人类佩吉病毒 (HPgV)、丙型肝炎病毒、帕雷奇病毒 1、鼻病毒 C、人类乳头瘤病毒 116、人类多瘤病毒 10、副病毒 B19 和托克特诺病毒 (TTV) 的不同变种。在这项研究中,发现了一种以前未知的病毒,属于短小病毒目伊夫拉病毒科。结论:这些结果凸显了儿童全身性病毒感染的广泛性,以及元基因组测序在病毒感染与癌症相关性假设形成方面的价值。
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引用次数: 0
High-risk HPV mRNA testing on self-samples offered to those who do not attend for organised cervical screening – real world data from the Dumfries and Galloway region in Scotland 对未参加有组织宫颈筛查者进行高风险 HPV mRNA 自采样检测--来自苏格兰邓弗里斯和加洛韦地区的真实数据
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-10-03 DOI: 10.1016/j.jcv.2024.105734
William Forson , Ramya Bhatia , Heather Currie , Hana Elasifer , Linzi Connor , Allan Wilson , Kate Cuschieri

Background

HPV self sampling can act as a tool to engage women in cervical screening and population based studies can inform optimal implementation of this approach.

Methods

Self sampling kits were mailed to women who had defaulted from routine screening resident in an entire territorial health board in Scotland. Kit return rates and compliance to colposcopy follow up in those who were HPV mRNA positive were assessed. Concordance of the self-sample with samples taken later at colposcopy was measured alongside PPV of an mRNA positive result for CIN2+.

Results

Of 4173 women invited to participate, 20.5 %, returned their kit and a greater return rate with increasing age was observed. HPV mRNA positivity was 12.0 %, and invalidity rate was approximately 3 %. Compliance to colposcopy follow up was 88.3 % and the PPV for an mRNA test for CIN2+ on a self sample was 25.6 %. hr-HPV concordance on the initial swab and the follow up swab and liquid based cytology (LBC) sample taken at colposcopy was 67.1 % and 30 % respectively.

Conclusions

HPV self sampling using a “mail to all” approach is feasible in Scotland although only 1 in 5 actively responded to the offer. Future work to monitor screening behaviours in those who were invited but did not engage initially will help quantify any additional benefit(s) incurred.
背景 HPV 自我采样可以作为一种工具,吸引妇女参与宫颈筛查,而基于人群的研究可以为这种方法的最佳实施提供信息。对 HPV mRNA 阳性者的工具包回收率和阴道镜随访依从性进行了评估。结果 在应邀参加筛查的 4173 名妇女中,20.5% 的人退回了试剂盒,而且随着年龄的增长,退回试剂盒的比例也在增加。HPV mRNA 阳性率为 12.0%,无效率约为 3%。对阴道镜随访的依从性为 88.3%,对自我样本进行 CIN2+ mRNA 检测的 PPV 为 25.6%。初次拭子与阴道镜随访拭子和液基细胞学 (LBC) 样本的 hr-HPV 一致性分别为 67.1% 和 30%。未来对那些收到邀请但最初未参与筛查的人的筛查行为进行监测的工作将有助于量化所产生的任何额外益处。
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引用次数: 0
Hepatitis B virus (HBV) viremia despite tenofovir disoproxil fumarate-containing antiretroviral therapy in persons with HBV/HIV coinfection 乙型肝炎病毒(HBV)携带者在接受含富马酸替诺福韦二吡呋酯的抗逆转录病毒治疗后仍出现病毒血症
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-10-02 DOI: 10.1016/j.jcv.2024.105733
Patrick Ryan , Elizabeth Odegard , Heidi Meeds , Margaret Lartey , Vincent J. Ganu , Kenneth Tachi , Hongmei Yang , Oluwayemisi Ojewale , Isaac Boamah , Adjoa Obo-Akwa , Kenneth Antwi , Peter L. Anderson , Jason T. Blackard , Awewura Kwara

Background

The goal of treatment of hepatitis B virus (HBV) and human immunodeficiency virus (HIV) coinfection is suppression of both viruses; yet incomplete HBV suppression on tenofovir (TFV) disoproxil fumarate (TDF)-based antiretroviral therapy (ART) is common. This study investigated TFV resistance-associated mutations (RAMs) in individuals with HBV/HIV coinfection with viremia on TDF/lamivudine (3TC)-containing ART.

Methods

Samples from individuals with HBV DNA levels ≥20 IU/mL in a cross-sectional study of 138 persons with HBV/HIV coinfection in Ghana were analyzed in the present study. HBV was sequenced for RAM analysis. TFV-diphosphate (TFV-DP) concentration in peripheral blood mononuclear cells (PBMCs) was used to assess ART adherence level.

Results

Nine of 138 participants (6.5 %) had detectable HBV DNA levels ≥20 IU/mL while on ART. Seven of the nine participants had TFV-DP concentrations commensurate with 7 doses per week, and six had suppressed HIV RNA. Phylogenetic analysis revealed that eight sequences were HBV genotype E, with one genotype E/A recombinant. Ten previously-reported TFV RAMs were present in the study samples; eight were wild-type for HBV genotype E. The non-genotype-E-wild-type point mutations M267L and K333Q were found in two and one patients, respectively. No 3TC RAMs were found.

Conclusion

HBV viremia despite high adherence to TDF/3TC-based ART may be associated with the presence of TFV RAMs. These findings highlight the need for enhanced resistance monitoring and further research to examine the clinical significance of reported TFV RAMs. Individuals with HBV/HIV coinfection and TFV resistance on TDF-based ART may need alternative treatment strategies.
背景治疗乙型肝炎病毒(HBV)和人类免疫缺陷病毒(HIV)合并感染的目标是抑制这两种病毒;然而,在基于替诺福韦(TFV)富马酸二吡呋酯(TDF)的抗逆转录病毒疗法(ART)中,HBV抑制不完全的情况很常见。本研究调查了在使用含 TDF/lamivudine (3TC) 的抗逆转录病毒疗法时出现病毒血症的 HBV/HIV 合并感染者的 TFV 耐药性相关突变 (RAM)。为进行 RAM 分析,对 HBV 进行了测序。外周血单核细胞(PBMCs)中的TFV-二磷酸(TFV-DP)浓度用于评估抗逆转录病毒疗法的依从性水平。结果138名参与者中有9人(6.5%)在接受抗逆转录病毒疗法期间检测到HBV DNA水平≥20 IU/mL。9 名参与者中有 7 人的 TFV-DP 浓度与每周 7 次服药相称,6 人的 HIV RNA 得到抑制。系统发育分析表明,8 个序列为 HBV 基因 E 型,其中 1 个为基因 E/A 重组型。研究样本中出现了 10 个以前报告过的 TFV RAM,其中 8 个是 HBV 基因型 E 的野生型。结论 尽管高度坚持以 TDF/3TC 为基础的抗逆转录病毒疗法,但 HBV 病毒血症可能与 TFV RAM 的存在有关。这些发现凸显了加强耐药性监测和进一步研究的必要性,以检查报告的 TFV RAMs 的临床意义。HBV/HIV合并感染者在使用TDF抗逆转录病毒疗法时出现TFV耐药,可能需要采取其他治疗策略。
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引用次数: 0
Investigation of suspected false positive norovirus results on a syndromic gastrointestinal multiplex molecular panel 对综合症胃肠道多重分子检测中诺如病毒假阳性结果的调查。
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-09-30 DOI: 10.1016/j.jcv.2024.105732
Mélissa Caza , Kevin Kuchinski , Kerstin Locher , Jonathan Gubbay , Matisse Harms , David M. Goldfarb , Rachel Floyd , Ethan Kenmuir , Marzieh Kalhor , Marthe Charles , Natalie Prystajecky , Amanda Wilmer

Background

Suspected false positive norovirus results occurred after introduction of the BioFire® FilmArray® Gastrointestinal panel (BF-GIP) into 6 laboratory sites, in British Columbia, Canada.

Objectives

The primary objective was to investigate suspected false positive results by performing additional molecular assays and whole genome sequencing (WGS). The second objective was to determine if melting curve review could predict false positive results.

Study design

From February 2023 to May 2024, the proportion of potential false positive norovirus results from the BF-GIP was calculated based on confirmatory testing using alternate molecular method. A subset of 65 norovirus BF-GIP positive specimens, including 35 negatives and 30 positives on additional molecular assays, underwent WGS. Melting curves appearances from 150 specimens were reviewed.

Results

Overall, 215/784 (27.4 %) BF-GIP norovirus results were suspected to be false positives. When using WGS, 64/65 results were in agreement with confirmatory testing. Notably, 35 specimens negative on confirmatory testing and suspected to be BF-GIP norovirus false positive results were undetectable by WGS. Melting curves did not accurately predict false positives, since 20/72 (27.8 %) had typical appearances upon review.

Conclusions

BF-GIP produces false positive results for norovirus, which cannot be predicted by melting curve review.
背景:加拿大不列颠哥伦比亚省的 6 家实验室在引入 BioFire® FilmArray® Gastrointestinal panel (BF-GIP) 后出现了诺如病毒假阳性结果:在加拿大不列颠哥伦比亚省的 6 个实验室引入 BioFire® FilmArray® Gastrointestinal panel (BF-GIP) 后,出现了诺如病毒假阳性结果:主要目的是通过执行额外的分子检测和全基因组测序 (WGS) 来调查疑似假阳性结果。第二个目标是确定熔解曲线审查能否预测假阳性结果:研究设计:从 2023 年 2 月到 2024 年 5 月,根据使用替代分子方法进行的确证检测结果,计算出 BF-GIP 可能出现的诺如病毒假阳性结果的比例。对 65 份诺如病毒 BF-GIP 阳性标本进行了 WGS 检测,其中包括 35 份阴性标本和 30 份经其他分子检测呈阳性的标本。对 150 份标本的熔解曲线进行了审查:总的来说,215/784(27.4%)个 BF-GIP 诺如病毒结果被怀疑为假阳性。在使用 WGS 时,64/65 的结果与确证检验结果一致。值得注意的是,35 份在确证检验中呈阴性、疑似 BF-GIP 诺如病毒假阳性结果的标本在 WGS 中检测不到。熔解曲线并不能准确预测假阳性,因为有 20/72 个样本(27.8%)在复查时出现了典型的外观:结论:BF-GIP 会产生诺如病毒假阳性结果,而熔解曲线检测无法预测假阳性结果。
{"title":"Investigation of suspected false positive norovirus results on a syndromic gastrointestinal multiplex molecular panel","authors":"Mélissa Caza ,&nbsp;Kevin Kuchinski ,&nbsp;Kerstin Locher ,&nbsp;Jonathan Gubbay ,&nbsp;Matisse Harms ,&nbsp;David M. Goldfarb ,&nbsp;Rachel Floyd ,&nbsp;Ethan Kenmuir ,&nbsp;Marzieh Kalhor ,&nbsp;Marthe Charles ,&nbsp;Natalie Prystajecky ,&nbsp;Amanda Wilmer","doi":"10.1016/j.jcv.2024.105732","DOIUrl":"10.1016/j.jcv.2024.105732","url":null,"abstract":"<div><h3>Background</h3><div>Suspected false positive norovirus results occurred after introduction of the BioFire® FilmArray® Gastrointestinal panel (BF-GIP) into 6 laboratory sites, in British Columbia, Canada.</div></div><div><h3>Objectives</h3><div>The primary objective was to investigate suspected false positive results by performing additional molecular assays and whole genome sequencing (WGS). The second objective was to determine if melting curve review could predict false positive results.</div></div><div><h3>Study design</h3><div>From February 2023 to May 2024, the proportion of potential false positive norovirus results from the BF-GIP was calculated based on confirmatory testing using alternate molecular method. A subset of 65 norovirus BF-GIP positive specimens, including 35 negatives and 30 positives on additional molecular assays, underwent WGS. Melting curves appearances from 150 specimens were reviewed.</div></div><div><h3>Results</h3><div>Overall, 215/784 (27.4 %) BF-GIP norovirus results were suspected to be false positives. When using WGS, 64/65 results were in agreement with confirmatory testing. Notably, 35 specimens negative on confirmatory testing and suspected to be BF-GIP norovirus false positive results were undetectable by WGS. Melting curves did not accurately predict false positives, since 20/72 (27.8 %) had typical appearances upon review.</div></div><div><h3>Conclusions</h3><div>BF-GIP produces false positive results for norovirus, which cannot be predicted by melting curve review.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105732"},"PeriodicalIF":4.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What have we learned from animal studies of immune responses to respiratory syncytial virus infection? 我们从呼吸道合胞病毒感染免疫反应的动物研究中学到了什么?
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-09-22 DOI: 10.1016/j.jcv.2024.105731
Simon B Drysdale , Ryan S Thwaites , Josephina Price , Devika Thakur , Joseph McGinley , Calum McPherson , Deniz Öner , Jeroen Aerssens , Peter JM Openshaw , Andrew J Pollard , On behalf of the RESCEU investigators
Respiratory syncytial virus (RSV) is a common cause of severe respiratory tract infection at the extremes of age and in vulnerable populations. However, it is difficult to predict the clinical course and most infants who develop severe disease have no pre-existing risk factors. With the recent licencing of RSV vaccines and monoclonal antibodies, it is important to identify high-risk individuals in order to prioritise those who will most benefit from prophylaxis. The immune response to RSV and the mechanisms by which the virus prevents the establishment of immunological memory have been extensively investigated but remain incompletely characterised. In animal models, beneficial and harmful immune responses have both been demonstrated. While only chimpanzees are fully permissive for human RSV replication, most research has been conducted in rodents, or in calves infected with bovine RSV. Based on these studies, components of innate and adaptive immune systems, cytokines, chemokines and metabolites, and specific genetic and transcriptomic signatures are identified as potential predictive indicators of RSV disease severity. These findings may inform the development of future human studies and contribute to the early identification of patients at high risk of severe infection. This narrative review summarises the factors involved in the immune response to RSV infection in these models and highlights the relationship between potential biomarkers and disease severity.
呼吸道合胞病毒(RSV)是极端年龄段和易感人群发生严重呼吸道感染的常见原因。然而,临床病程很难预测,而且大多数患严重疾病的婴儿都没有预先存在的危险因素。随着 RSV 疫苗和单克隆抗体最近获得许可,确定高危人群以便优先考虑那些从预防中获益最多的人就显得非常重要。人们对 RSV 的免疫反应以及病毒阻止免疫记忆建立的机制进行了广泛研究,但对其特征的描述仍不完整。在动物模型中,有益和有害的免疫反应都已得到证实。虽然只有黑猩猩完全允许人类 RSV 复制,但大多数研究都是在啮齿动物或感染牛 RSV 的小牛身上进行的。基于这些研究,先天性免疫系统和适应性免疫系统的成分、细胞因子、趋化因子和代谢物以及特定的基因和转录组特征被确定为 RSV 疾病严重程度的潜在预测指标。这些发现可为未来人类研究的发展提供参考,并有助于早期识别严重感染高风险患者。本综述总结了这些模型中对 RSV 感染的免疫反应所涉及的因素,并强调了潜在生物标志物与疾病严重程度之间的关系。
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引用次数: 0
Circulating serotypes and genotypes of dengue virus during the 2023 outbreak in Eastern Nepal 2023 年尼泊尔东部爆发登革热疫情期间登革热病毒的流行血清型和基因型
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-08-30 DOI: 10.1016/j.jcv.2024.105721
Niten Bharati , Shyam Prakash Dumre , Yogendra Shah , Takeshi Nabesima , Meghnath Dhimal , Srijana Pandey , Merveille Kapandji , Yuki Takamatsu , Takeshi Urano , Basu Dev Pandey , Kouichi Morita , Mya Myat Ngwe Tun , Kishor Pandey

Dengue virus (DENV) is one of the most significant mosquito-borne diseases in Nepal. In 2023, DENV outbreaks began in Eastern Nepal, near the border with India, and rapidly spread nationwide. The study aims to describe the outbreak's epidemiological pattern, laboratory characteristics, DENV serotypes, and genotypes. A hospital-based cross-sectional study was conducted in four hospitals in Jhapa, Eastern Nepal, in 2023. Acute serum samples were obtained from dengue suspected patients within 7 days of illness and subjected to virus isolation, conventional and real-time polymerase chain reaction (RT-PCR), and phylogenetic analysis. Out of 60 samples, 42 (70 %), 11 (18.3 %) and 7 (11.7 %) were primary, secondary and non-dengue infection, respectively. Among 53 dengue confirmed patients, 46 (86.7 %) were positive for NS1 and 12 (22.6 %) were positive for both NS1 and IgM. Out of 42 dengue isolates, a new clade of the cosmopolitan genotype of DENV-2 was the most prevalent (28, 66.7 %), followed by genotype III of DENV-3 (11, 26.2 %) and genotype V of DENV-1 (3, 7.1 %). Genotype III of DENV-3 was first introduced in 2022–2023 in Nepal. Phylogenetic analysis of the E gene revealed the DENV-2 isolates from Nepal had 98 % homologous nucleotide similarity with the strains from India and Bangladesh. To our knowledge, this is the first report of circulating serotypes and genotypes of DENV in Jhapa. Integrating molecular findings into the dengue control plan can enhance surveillance efforts, monitor disease trends, and implement proactive measures to reduce the burden of dengue and prevent fatalities in future outbreaks.

登革热病毒(DENV)是尼泊尔最主要的蚊媒疾病之一。2023 年,登革热病毒在靠近印度边境的尼泊尔东部开始爆发,并迅速蔓延至全国。本研究旨在描述疫情的流行病学模式、实验室特征、DENV 血清型和基因型。2023 年,在尼泊尔东部贾帕的四家医院开展了一项基于医院的横断面研究。研究人员从登革热疑似患者身上采集了发病 7 天内的急性血清样本,并对样本进行了病毒分离、传统和实时聚合酶链反应(RT-PCR)以及系统发育分析。在 60 份样本中,原发性、继发性和非登革热感染样本分别为 42 份(70%)、11 份(18.3%)和 7 份(11.7%)。在 53 名登革热确诊患者中,46 人(86.7%)对 NS1 呈阳性,12 人(22.6%)对 NS1 和 IgM 均呈阳性。在 42 个登革热分离株中,DENV-2 的世界性基因型新支系最为流行(28 个,66.7%),其次是 DENV-3 的基因型 III(11 个,26.2%)和 DENV-1 的基因型 V(3 个,7.1%)。DENV-3 基因型 III 于 2022-2023 年首次在尼泊尔出现。E基因的系统进化分析表明,尼泊尔的DENV-2分离株与印度和孟加拉国的菌株具有98%的同源核苷酸相似性。据我们所知,这是有关贾帕地区流行的 DENV 血清型和基因型的首次报告。将分子研究结果纳入登革热控制计划可加强监测工作、监测疾病趋势并实施积极措施,以减轻登革热的负担并防止在未来爆发时造成死亡。
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引用次数: 0
Opportunities and challenges for the U.S. laboratory response to highly pathogenic avian influenza A(H5N1) 美国实验室应对甲型 H5N1 高致病性禽流感的机遇与挑战
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-08-26 DOI: 10.1016/j.jcv.2024.105723
Benjamin A. Pinsky , Benjamin T. Bradley

On March 25, 2024 an outbreak of highly pathogenic avian influenza (HPAI) A H5N1 was identified in dairy cows across multiple farms in the United States. Zoonotic cases originating in individuals with close contact to infected herds and poultry flocks have been subsequently identified. Spillover events such as this raise the specter of recent pandemics including COVID-19 and Mpox and may lead clinical laboratories to assess their capacity for diagnosis of HPAI H5N1. In this review, we detail the origins of the H5N1 clade 2.3.4.4b outbreak as well as the existing capacity to identify HPAI H5N1 as influenza A virus by commercially available assays. Furthermore, we highlight the absence of commercially available influenza A H5 subtyping assays and limitations associated with the current 510(k)-cleared assay. This outbreak also serves as an early opportunity to assess the new and unknown regulatory challenges faced by laboratory-developed tests in light of the FDA's final rule on in vitro diagnostic devices. National agencies along with public health and clinical laboratories all serve an essential role in the response to HPAI H5N1. To most effectively utilize each group's strength requires open communication and willingness to embrace novel approaches.

2024 年 3 月 25 日,在美国多个农场的奶牛中发现了甲型 H5N1 高致病性禽流感疫情。随后又发现与受感染牛群和禽群有密切接触的个人感染人畜共患病例。此类蔓延事件使人联想到最近的大流行病(包括 COVID-19 和 Mpox),并可能促使临床实验室评估其诊断高致病性禽流感 H5N1 的能力。在本综述中,我们详细介绍了 H5N1 2.3.4.4b 支系疫情的起源,以及通过市售检测方法将高致病性禽流感 H5N1 识别为甲型流感病毒的现有能力。此外,我们还强调了市场上缺乏甲型 H5 亚型检测方法以及当前 510(k) 许可检测方法的局限性。此次疫情也为我们提供了一个早期机会,根据美国食品及药物管理局(FDA)关于体外诊断设备的最终规定,评估实验室开发的检测方法所面临的新的和未知的监管挑战。在应对高致病性禽流感 H5N1 的过程中,国家机构、公共卫生和临床实验室都发挥着至关重要的作用。要想最有效地利用每个团体的力量,就需要坦诚沟通并愿意接受新方法。
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引用次数: 0
Performance evaluation of the quantitative assay Adenovirus ELITe MGB® Kit on EDTA-plasma, using the ELITe BeGenius® system 使用 ELITe BeGenius® 系统对 EDTA 血浆上的腺病毒 ELITe MGB® 定量检测试剂盒进行性能评估
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-08-24 DOI: 10.1016/j.jcv.2024.105722
Edwin Fries, Tessa Kalmeijer, Lara Spaans, Martin Rakké, Rob Schuurman, Jolanda D F De Groot-Mijnes

Background

Adenovirus infections constitute an important cause of morbidity and mortality after hematopoietic stem cell transplantation. Detection and monitoring of adenovirus in EDTA-plasma by real-time quantitative PCR is a sensitive tool for identification and management of patients at risk of a potentially fatal infection.

Objectives

The aim of this study was to evaluate the analytical and clinical performance of the quantitative Adenovirus ELITe MGB® Kit (ELITechGroup S.p.A.) using the ELITe BeGenius® (ELITechGroup S.p.A.) system and compare the assay to a laboratory-developed quantitative real-time PCR assay.

Study design

Analytical sensitivity of the Adenovirus ELITe MGB® Kit was determined by testing serial dilutions of the WHO standard. Detection of adenovirus serotypes was assessed using a panel of 51 serotypes. Clinical sensitivity and specificity were determined by comparing the Adenovirus ELITe MGB® Kit results with the laboratory-developed assay results of 155 retrospective and prospective EDTA-plasma samples from transplant recipients.

Results

The analytical sensitivity of the Adenovirus ELITe MGB® Kit was at least 54 (1.7 Log) IU/mL and the quantitative results showed a high correlation with the WHO standard (R2 = 0.9978; Pearson) within the range of 1.7 to 6.6 Log IU/mL. All 51 adenovirus serotypes were detected. The clinical specificity and sensitivity for EDTA plasma of the Adenovirus ELITe MGB® Kit were 97.4 % and 99.1 % respectively.

Conclusion

The Adenovirus ELITe MGB® Kit performed on the ELITe BeGenius® system is a highly sensitive and specific assay for the detection of adenovirus in EDTA-plasma from transplantation patients.

背景腺病毒感染是造血干细胞移植后发病和死亡的重要原因。通过实时定量 PCR 检测和监测 EDTA 血浆中的腺病毒是一种灵敏的工具,可用于识别和管理面临潜在致命感染风险的患者。p.A.)系统的分析和临床性能,并将该检测方法与实验室开发的定量实时 PCR 检测方法进行比较。研究设计通过检测世卫组织标准的系列稀释液确定腺病毒 ELITe MGB® 检测试剂盒的分析灵敏度。腺病毒血清型的检测使用 51 种血清型的面板进行评估。结果腺病毒 ELITe MGB® 检测试剂盒的分析灵敏度至少为 54 (1.7 Log) IU/mL,定量结果在 1.7 至 6.6 Log IU/mL 范围内与 WHO 标准(R2 = 0.9978;Pearson)高度相关。所有 51 种腺病毒血清型均被检测到。腺病毒 ELITe MGB® 检测试剂盒对 EDTA 血浆的临床特异性和灵敏度分别为 97.4 % 和 99.1 %。
{"title":"Performance evaluation of the quantitative assay Adenovirus ELITe MGB® Kit on EDTA-plasma, using the ELITe BeGenius® system","authors":"Edwin Fries,&nbsp;Tessa Kalmeijer,&nbsp;Lara Spaans,&nbsp;Martin Rakké,&nbsp;Rob Schuurman,&nbsp;Jolanda D F De Groot-Mijnes","doi":"10.1016/j.jcv.2024.105722","DOIUrl":"10.1016/j.jcv.2024.105722","url":null,"abstract":"<div><h3>Background</h3><p>Adenovirus infections constitute an important cause of morbidity and mortality after hematopoietic stem cell transplantation. Detection and monitoring of adenovirus in EDTA-plasma by real-time quantitative PCR is a sensitive tool for identification and management of patients at risk of a potentially fatal infection.</p></div><div><h3>Objectives</h3><p>The aim of this study was to evaluate the analytical and clinical performance of the quantitative Adenovirus ELITe MGB® Kit (ELITechGroup S.p.A.) using the ELITe BeGenius® (ELITechGroup S.p.A.) system and compare the assay to a laboratory-developed quantitative real-time PCR assay.</p></div><div><h3>Study design</h3><p>Analytical sensitivity of the Adenovirus ELITe MGB® Kit was determined by testing serial dilutions of the WHO standard. Detection of adenovirus serotypes was assessed using a panel of 51 serotypes. Clinical sensitivity and specificity were determined by comparing the Adenovirus ELITe MGB® Kit results with the laboratory-developed assay results of 155 retrospective and prospective EDTA-plasma samples from transplant recipients.</p></div><div><h3>Results</h3><p>The analytical sensitivity of the Adenovirus ELITe MGB® Kit was at least 54 (1.7 Log) IU/mL and the quantitative results showed a high correlation with the WHO standard (R<sup>2</sup> = 0.9978; Pearson) within the range of 1.7 to 6.6 Log IU/mL. All 51 adenovirus serotypes were detected. The clinical specificity and sensitivity for EDTA plasma of the Adenovirus ELITe MGB® Kit were 97.4 % and 99.1 % respectively.</p></div><div><h3>Conclusion</h3><p>The Adenovirus ELITe MGB® Kit performed on the ELITe BeGenius® system is a highly sensitive and specific assay for the detection of adenovirus in EDTA-plasma from transplantation patients.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"174 ","pages":"Article 105722"},"PeriodicalIF":4.0,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000842/pdfft?md5=88fd9eb10ab5d2d1b647b5baa173f74d&pid=1-s2.0-S1386653224000842-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142087910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Influenza C virus in U.S. children with acute respiratory infection 2016–2019 2016-2019 年美国儿童急性呼吸道感染中的丙型流感病毒
IF 4 3区 医学 Q2 VIROLOGY Pub Date : 2024-08-08 DOI: 10.1016/j.jcv.2024.105720
Bethany K. Sederdahl , Geoffrey A. Weinberg , Angela P. Campbell , Rangaraj Selvarangan , Jennifer E. Schuster , Joana Y. Lively , Samantha M. Olson , Julie A. Boom , Pedro A. Piedra , Natasha B. Halasa , Laura Stewart , Peter G. Szilagyi , G.K. Balasubramani , Theresa Sax , Judith M. Martin , Robert W. Hickey , Marian G. Michaels , John V. Williams , New Vaccine Surveillance Network

Influenza C virus (ICV) is an orthomyxovirus related to influenza A and B, yet due to few commercial assays, epidemiologic studies may underestimate incidence of ICV infection and disease. We describe the epidemiology and characteristics of ICV within the New Vaccine Surveillance Network (NVSN), a Centers for Disease Control and Prevention (CDC)-led network that conducts population-based surveillance for pediatric acute respiratory illness (ARI). Nasal or/combined throat swabs were collected from emergency department (ED) or inpatient ARI cases, or healthy controls, between 12/05/2016–10/31/2019 and tested by molecular assays for ICV and other respiratory viruses. Parent surveys and chart review were used to analyze demographic and clinical characteristics of ICV+ children. Among 19,321 children tested for ICV, 115/17,668 (0.7 %) ARI cases and 8/1653 (0.5 %) healthy controls tested ICV+. Median age of ICV+ patients was 18 months and 88 (71.5 %) were ≤36 months. Among ICV+ ARI patients, 40 % (46/115) were enrolled in the ED, 60 % (69/115) were inpatients, with 15 admitted to intensive care. Most ICV+ ARI patients had fever (67.8 %), cough (94.8 %), or wheezing (60.9 %). Most (60.9 %) ARI cases had ≥1 co-detected viruses including rhinovirus, RSV, and adenovirus. In summary, ICV detection was rarely associated with ARI in children, and most ICV+ patients were ≤3 years old with co-detected respiratory viruses.

丙型流感病毒(ICV)是一种与甲型流感和乙型流感相关的正粘病毒,但由于商用检测方法很少,流行病学研究可能会低估 ICV 感染和疾病的发病率。我们描述了新疫苗监测网络(NVSN)中 ICV 的流行病学和特征,该网络由美国疾病控制和预防中心(CDC)领导,对儿科急性呼吸道疾病(ARI)进行基于人群的监测。在 2016 年 12 月 5 日至 2019 年 10 月 31 日期间,从急诊科 (ED) 或住院 ARI 病例或健康对照者处采集鼻拭子或/混合咽拭子,并通过分子检测法对 ICV 和其他呼吸道病毒进行检测。家长调查和病历审查用于分析ICV+儿童的人口统计学和临床特征。在接受 ICV 检测的 19,321 名儿童中,115 名/17,668 名(0.7%)ARI 病例和 8/1653 名(0.5%)健康对照组接受了 ICV+检测。ICV+患者的中位年龄为18个月,88人(71.5%)的年龄小于36个月。在 ICV+ ARI 患者中,40%(46/115)是在急诊室登记的,60%(69/115)是住院患者,其中 15 人住进了重症监护室。大多数 ICV+ ARI 患者有发热(67.8%)、咳嗽(94.8%)或喘息(60.9%)。大多数(60.9%)ARI 病例合并检测到≥1 种病毒,包括鼻病毒、RSV 和腺病毒。总之,ICV 检测很少与儿童急性呼吸道感染相关联,大多数 ICV+ 患者年龄小于 3 岁,并同时检测到呼吸道病毒。
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引用次数: 0
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Journal of Clinical Virology
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