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Prevalence and characteristics of Hepatitis B and other transfusion-transmitted infections among blood donors in Albania: Implications for blood safety and screening strategies 阿尔巴尼亚献血者中乙型肝炎和其他输血传播感染的流行和特征:对血液安全和筛查策略的影响
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-12-23 DOI: 10.1016/j.jcvp.2025.100240
Albana Gjyzari , Irini Kasolli , Irena Seferi , Ariana Strakosha , Ergys Ramosacaj , Esmeralda Thoma , Admir Nake , Altea Gjyzari , Drieda Zaçe

Introduction

Blood transfusion, although lifesaving, may carry inherit risks, including transfusion-transmitted infections (TTIs). This study aims to assess the prevalence and characteristics of HBV infection, including occult HBV and other TTIs (HCV, HIV and syphilis) among blood donors in Albania.

Methods

This retrospective observational study analysed blood donor samples from the National Blood Transfusion Center in Tirana (January–December 2024). Serological assays and nucleic acid testing (NAT) were performed following standard protocols. All donations positive for HBsAg, HCV, syphilis, HIV, NAT triple assay, or with ALT >2 × ULN were included. Demographic and clinical data collected comprised age, gender, region, education level, blood type, BMI, and ALT values.

Results

Among 25,474 donors, 6.4 % tested positive at the first screening for at least one infection marker or liver injury indicator. Most positive cases were male (82 %), with a median age of 40 years, and had secondary education (42 %). Serology identified HBsAg 2.8 %, anti HCV 0.6 %, HIV 0.1 % (confirmed positive 0.057 %), and syphilis 0.4 % (confirmed positive 0.15 %). Overall, a prevalence of 3.1 % for confirmed active infections (HBV, HCV, HIV and syphilis) was found. NAT triple assay was reactive in 860 samples; 65 HBsAg-negative cases (0.2 %) were confirmed as HBV-DNA positive (occult HBV infection, OBI). OBI cases had a median anti-HBc and anti-HBs titers of 6.3 and 7.3 respectively, with 40 % showing positive anti-HBs levels. No significant demographic or clinical differences were found between anti-HBs positive and negative individuals. In multivariable analysis, lack of vaccination, lower education, and lower ALT remained independent predictors of HBV infection.

Conclusions

This study emphasizes the importance of comprehensive screening strategies, including NAT, to identify occult infections that could compromise blood safety. Continued promotion of vaccination, education, and regional surveillance is essential to reduce the burden of HBV and other TTIs in blood donors and the general population.
输血虽然可以挽救生命,但也可能带来遗传风险,包括输血传播感染(tti)。本研究旨在评估阿尔巴尼亚献血者中HBV感染的患病率和特征,包括隐匿性HBV和其他tti (HCV、HIV和梅毒)。方法本回顾性观察性研究分析了地拉那国家输血中心(2024年1月至12月)的献血者样本。血清学测定和核酸检测(NAT)按照标准方案进行。所有捐献的HBsAg、HCV、梅毒、HIV、NAT三联试验阳性或ALT >;2 × ULN阳性均纳入研究。收集的人口学和临床数据包括年龄、性别、地区、教育程度、血型、BMI和ALT值。结果25474名献血者中,6.4%在首次筛查时至少有一项感染标志物或肝损伤指标呈阳性。大多数阳性病例为男性(82%),中位年龄40岁,受过中等教育(42%)。血清学检测HBsAg 2.8%,抗HCV 0.6%, HIV 0.1%(确诊阳性0.057%),梅毒0.4%(确诊阳性0.15%)。总体而言,发现确诊活动性感染(HBV、HCV、HIV和梅毒)的患病率为3.1%。860份样品的NAT三重分析均有反应;65例hbsag阴性(0.2%)被证实为HBV- dna阳性(隐匿性HBV感染,OBI)。OBI患者的中位抗hbc和抗hbs滴度分别为6.3和7.3,其中40%显示抗hbs水平阳性。在抗hbs阳性和阴性个体之间没有发现显著的人口统计学或临床差异。在多变量分析中,缺乏疫苗接种、低教育水平和较低的ALT仍然是HBV感染的独立预测因素。结论:本研究强调了综合筛查策略的重要性,包括NAT,以识别可能危及血液安全的隐性感染。继续促进疫苗接种、教育和区域监测对于减轻献血者和一般人群中HBV和其他传播感染的负担至关重要。
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引用次数: 0
Viral haemorrhagic fever (Marburg) outbreak in Ethiopia: global health response and preparedness lessons for East Africa 埃塞俄比亚病毒性出血热(马尔堡)暴发:东非的全球卫生应对和防范经验教训
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-12-11 DOI: 10.1016/j.jcvp.2025.100238
Mohamed Mustaf Ahmed , Eilham Elias Jobir , Abdirasak Sharif Ali
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引用次数: 0
Clinical performance of the BD Respiratory Viral Panel – SCV2 for BD MAX™ system with nasopharyngeal and anterior nasal specimens BD呼吸道病毒面板- SCV2用于BD MAX™系统的鼻咽和前鼻标本的临床表现
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-12-11 DOI: 10.1016/j.jcvp.2025.100237
Sonia Paradis , Barbara Van Der Pol , Thomas E. Davis , Nathan A. Ledeboer , Matthew L. Faron , William Laviers , Jeffry Leitch , Elizabeth Lockamy , Karen A. Yanson

Background

The detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) relies heavily on highly sensitive and specific assays. While nasopharyngeal (NP) specimens are considered the gold standard, it is crucial that current assays also support the use of anterior nasal swab (NS) specimens, as they can be more suitable in situations where NP specimen collection is difficult or impractical.

Methods

Paired NP and NS specimens prospectively collected from symptomatic and asymptomatic participants were utilized to evaluate the BD Respiratory Viral Panel - SCV2 for BD MAX™ System (BD RVP SCV2) clinical performance against a composite comparator of three CE-marked assays: cobas® SARS-CoV-2, Aptima® SARS-CoV-2, and Lyra® SARS-CoV-2. Concordance between at least two assays established a positive or negative comparator result. Each specimen was divided into four aliquots, one for each assay. BD RVP SCV2 performance was assessed by comparing results from NP specimens (NP vs NP), NS specimens (NS vs NS), and NS results with paired NP comparator results (NS vs NP). Positive and negative percent agreements (PPA and NPA) were calculated for all comparisons.

Results

Combined symptomatic and asymptomatic specimens, when tested with the BD RVP SCV2 assay, met all set acceptance criteria, with PPAs of 98.7 % (NP vs NP), 98.4 % (NS vs NS), and 92.6 % (NS vs NP) while NPAs ranged from 97.7 % to 98.0 %.

Conclusions

These findings confirm that the BD Respiratory Viral Panel - SCV2 for BD MAX System performs well for detecting SARS-CoV-2 in NP and NS specimens from symptomatic and asymptomatic populations.
背景严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)的检测在很大程度上依赖于高度敏感和特异性的检测方法。虽然鼻咽(NP)标本被认为是金标准,但至关重要的是,目前的检测方法也支持使用鼻前拭子(NS)标本,因为它们可能更适合在NP标本收集困难或不切实际的情况下。方法从有症状和无症状的参与者中前瞻性收集的spadian NP和NS标本,与cobas®SARS-CoV-2、Aptima®SARS-CoV-2和Lyra®SARS-CoV-2这三种ce标记的检测方法的复合比较物对比,评估BD呼吸道病毒面板- SCV2 for BD MAX™系统(BD RVP SCV2)的临床表现。至少两个测定之间的一致性建立了阳性或阴性比较结果。每个标本被分成四个等分,每个测定一个。通过比较NP标本(NP vs NP)、NS标本(NS vs NS)和NS结果与配对NP比较结果(NS vs NP)来评估BD RVP SCV2的性能。所有比较都计算了协议的正面和负面百分比(PPA和NPA)。结果合并有症状和无症状的标本,当用BD RVP SCV2检测时,符合所有设定的接受标准,ppa为98.7% (NP vs NP), 98.4% (NS vs NS)和92.6% (NS vs NP),而NPAs范围为97.7%至98.0%。结论应用于BD MAX系统的BD呼吸道病毒面板- SCV2检测有症状和无症状人群的NP和NS标本中SARS-CoV-2具有良好的检测效果。
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引用次数: 0
Comments on “Prognostic value of inflammatory markers including neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, mean platelet volume, platelet distribution width, and red blood cell distribution width in viral hepatitis: A systematic review and meta-analysis” 《中性粒细胞与淋巴细胞比值、血小板与淋巴细胞比值、平均血小板体积、血小板分布宽度和红细胞分布宽度在病毒性肝炎中的预后价值:一项系统综述和荟萃分析》
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-12-11 DOI: 10.1016/j.jcvp.2025.100239
Sushma Narsing Katkuri , Varshini Vadhithala , Arun Kumar , Sushma Verma , Dhanya Dedeepya
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引用次数: 0
Human papillomavirus vaccination and screening in GCC countries: Review of current status, challenges, and future directions 海合会国家的人乳头瘤病毒疫苗接种和筛查:审查现状、挑战和未来方向
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-11-01 DOI: 10.1016/j.jcvp.2025.100235
Lama Alzamil
Cervical cancer remains a preventable yet significant public health challenge, particularly in regions where access to Human papillomavirus (HPV) vaccination and screening is limited. The Gulf Cooperation Council (GCC) countries comprising; Saudi Arabia, United Arab Emirates (UAE), Kuwait, Bahrain, Qatar, and Oman, have shown notable progress in introducing HPV vaccination; however, implementation remains inconsistent and coverage rates are suboptimal. Despite their economic capacity, most GCC states lack population-based cervical cancer screening programs, relying instead on opportunistic screening largely limited to married women. Cultural and religious sensitivities surrounding sexually transmitted infections contribute to stigma, delayed diagnosis, and low public engagement. While countries like Saudi Arabia and the UAE have issued national guidelines and incorporated HPV vaccination into school-based programs, others such as Oman and Bahrain still face significant gaps in both policy and the public health infrastructure needed to support organized HPV vaccination and cervical cancer screening programs. Screening strategies remain outdated or poorly implemented, with few countries adopting HPV-DNA testing. Sociocultural barriers, particularly the association of cervical cancer risk with marital status, continue to limit equitable access to preventive services. Promising approaches to improve uptake include the adoption of HPV self-sampling, school-based immunization, and integration of HPV vaccination into premarital health checks. Addressing these systemic and cultural challenges is essential for the GCC to align with global cervical cancer elimination goals and ensure broader protection for at-risk populations.
宫颈癌仍然是一个可预防但重大的公共卫生挑战,特别是在获得人乳头瘤病毒(HPV)疫苗接种和筛查机会有限的地区。海湾合作委员会(海合会)国家包括:沙特阿拉伯、阿拉伯联合酋长国、科威特、巴林、卡塔尔和阿曼在引入人乳头瘤病毒疫苗接种方面取得了显著进展;然而,实现仍然不一致,覆盖率不够理想。尽管有经济能力,大多数海湾合作委员会国家缺乏以人口为基础的宫颈癌筛查项目,而是依赖于主要限于已婚妇女的机会性筛查。围绕性传播感染的文化和宗教敏感性导致污名化、诊断延误和公众参与度低。虽然沙特阿拉伯和阿联酋等国家已经发布了国家指导方针,并将HPV疫苗接种纳入学校项目,但阿曼和巴林等其他国家在支持有组织的HPV疫苗接种和宫颈癌筛查项目所需的政策和公共卫生基础设施方面仍面临重大差距。筛查策略仍然过时或执行不力,很少有国家采用HPV-DNA检测。社会文化障碍,特别是宫颈癌风险与婚姻状况之间的联系,继续限制公平获得预防服务。提高吸入性的有希望的方法包括采用人乳头瘤病毒自我抽样、学校免疫以及将人乳头瘤病毒疫苗接种纳入婚前健康检查。应对这些系统和文化挑战对于海湾合作委员会与全球消除宫颈癌目标保持一致并确保对高危人群提供更广泛的保护至关重要。
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引用次数: 0
What is the proportion of samples reported as positive among reactive samples in Siemens Atellica IM analyzer HIV and HCV serological screening? 在Siemens Atellica IM分析仪的HIV和HCV血清学筛查中,阳性样本的比例是多少?
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-11-01 DOI: 10.1016/j.jcvp.2025.100232
Jesper M. Kivelä, Anne Toivonen, Maarit Ahava, Satu Kurkela

Background

Serological screening of transmissible blood-borne viruses, like HIV and HCV, is a seminal part of medical laboratory workflow. Reliable screening methods are vital to provide impetus for confirmation testing, since false reactive results occur with HIV and HCV immunoassays.

Objectives

We analyzed what proportion of the reactive HIV Ag/Ab and anti-HCV serum samples with Siemens Atellica IM Analyzer were finally reported as positive after confirmation testing.

Study design

Reactive samples with Atellica IM Analyzers using HIV Ag/Ab Combo Assay (HIV Ag/Ab) or Atellica IM Hepatitis C assay (anti-HCV) analyzed between 1/2021-4/2023 were queried from our laboratory system. Index cut-off for reactive sample was ≥1.00 for HIV Ag/Ab and ≥0.80 for anti-HCV. All reactive samples underwent confirmation testing and were interpreted by clinical microbiologists. We calculated the proportion of positive results amidst reactive samples with Atellica IM Analyzers. We used index categorization based on our laboratory workflow for confirmation testing.

Results

Of 802 reactive HIV Ag/Ab and 3100 reactive anti-HCV samples, 69 % (95 % CI 66-72 %) and 96 % (95 % CI 95-97 %) were eventually reported positive. Reactive samples with an index over measurement range were almost exclusively reported as positive with high posterior probabilities. Reactive HIV Ag/Ab samples within a very low or low reactivity category were seldom reported as positive.

Conclusions

Most reactive samples with Atellica IM Analyzer were reported positive, nonetheless up to 31 % of HIV Ag/Ab and 4 % of anti-HCV samples were false reactives. These data can be utilized in designing algorithms for confirmation testing in clinical laboratories.
背景:血液传播病毒(如HIV和HCV)的血清学筛查是医学实验室工作流程的重要组成部分。可靠的筛查方法对于提供确认检测的动力至关重要,因为HIV和HCV免疫测定会出现假反应结果。目的分析西门子Atellica IM分析仪检测的HIV Ag/Ab阳性和抗hcv阳性血清样本经确证后最终报告阳性的比例。研究设计从我们的实验室系统中查询在2021年1月至2023年4月期间使用Atellica IM分析仪使用HIV Ag/Ab组合检测(HIV Ag/Ab)或Atellica IM丙型肝炎检测(anti-HCV)分析的反应性样品。阳性样本HIV Ag/Ab指数临界值≥1.00,抗hcv指数临界值≥0.80。所有反应性样品都经过了确认测试,并由临床微生物学家进行了解释。我们用Atellica IM分析仪计算了反应样品中阳性结果的比例。我们使用索引分类基于我们的实验室工作流程进行确认测试。结果802份HIV Ag/Ab阳性样本和3100份抗hcv阳性样本中,分别有69% (95% CI 66 ~ 72%)和96% (95% CI 95 ~ 97%)最终呈阳性。指数超过测量范围的反应性样品几乎完全报告为具有高后验概率的阳性。极低或低反应性类别的反应性HIV Ag/Ab样本很少报告为阳性。结论大多数用Atellica IM分析仪检测的样本呈阳性,但高达31%的HIV Ag/Ab和4%的抗- hcv样本呈假反应。这些数据可用于设计临床实验室确认测试的算法。
{"title":"What is the proportion of samples reported as positive among reactive samples in Siemens Atellica IM analyzer HIV and HCV serological screening?","authors":"Jesper M. Kivelä,&nbsp;Anne Toivonen,&nbsp;Maarit Ahava,&nbsp;Satu Kurkela","doi":"10.1016/j.jcvp.2025.100232","DOIUrl":"10.1016/j.jcvp.2025.100232","url":null,"abstract":"<div><h3>Background</h3><div>Serological screening of transmissible blood-borne viruses, like HIV and HCV, is a seminal part of medical laboratory workflow. Reliable screening methods are vital to provide impetus for confirmation testing, since false reactive results occur with HIV and HCV immunoassays.</div></div><div><h3>Objectives</h3><div>We analyzed what proportion of the reactive HIV Ag/Ab and anti-HCV serum samples with Siemens Atellica IM Analyzer were finally reported as positive after confirmation testing.</div></div><div><h3>Study design</h3><div>Reactive samples with Atellica IM Analyzers using HIV Ag/Ab Combo Assay (HIV Ag/Ab) or Atellica IM Hepatitis C assay (anti-HCV) analyzed between 1/2021-4/2023 were queried from our laboratory system. Index cut-off for reactive sample was ≥1.00 for HIV Ag/Ab and ≥0.80 for anti-HCV. All reactive samples underwent confirmation testing and were interpreted by clinical microbiologists. We calculated the proportion of positive results amidst reactive samples with Atellica IM Analyzers. We used index categorization based on our laboratory workflow for confirmation testing.</div></div><div><h3>Results</h3><div>Of 802 reactive HIV Ag/Ab and 3100 reactive anti-HCV samples, 69 % (95 % CI 66-72 %) and 96 % (95 % CI 95-97 %) were eventually reported positive. Reactive samples with an index over measurement range were almost exclusively reported as positive with high posterior probabilities. Reactive HIV Ag/Ab samples within a very low or low reactivity category were seldom reported as positive.</div></div><div><h3>Conclusions</h3><div>Most reactive samples with Atellica IM Analyzer were reported positive, nonetheless up to 31 % of HIV Ag/Ab and 4 % of anti-HCV samples were false reactives. These data can be utilized in designing algorithms for confirmation testing in clinical laboratories.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 4","pages":"Article 100232"},"PeriodicalIF":1.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145415708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
“Systematic review of HHV-6 and febrile seizures: Should the ER include it in the viral panel?” “对HHV-6和热性惊厥的系统回顾:急诊室是否应将其纳入病毒检查小组?”
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-11-01 DOI: 10.1016/j.jcvp.2025.100233
Valerie Foy , Shaina Gagadam

Background

Human herpesvirus 6 (HHV-6), particularly subtype B, is a common viral infection in childhood and the cause of roseola infantum. Beyond its dermatologic effects, HHV-6B is an important yet often underrecognized contributor to febrile seizures in young children presenting to the emergency department (ED).

Objective

This systematic review aims to examine the virology, epidemiology, and clinical features of HHV-6 infection in children, focusing on neurologic manifestations, while evaluating current ED diagnostic practices and the potential role for HHV-6 testing in pediatric febrile seizures.

Methods

Following PRISMA guidelines, a comprehensive search of PubMed and Embase databases identified studies published up to September 2025 on HHV-6 virology, dermatologic findings, neurologic complications, and ED management in pediatric patients. Inclusion criteria focused on HHV-6′s role in febrile seizures and the utility of rapid molecular diagnostics in the ED. Search terms included keywords related to HHV-6, febrile seizures, and pediatric emergency care. Two reviewers independently performed full-text reviews and extracted data.

Results

Primary HHV-6B infection affects most children by age two, with up to 30 % of first febrile seizures in this group attributed to the virus. While mostly self-limited, HHV-6B is disproportionately associated with complex febrile seizures and febrile status epilepticus. Emerging rapid diagnostic tools offer opportunities for targeted testing in select high-risk populations but are costly.

Conclusions

HHV-6B is an underrecognized cause of febrile seizures in pediatrics. Selective screening for complex or prolonged seizures may enhance improve long-term outcomes. Until stronger evidence emerges, clinicians should interpret HHV-6B results within the broader clinical context.
人类疱疹病毒6 (HHV-6),特别是B亚型,是儿童时期常见的病毒感染,也是婴儿红疹的病因。除了它的皮肤效应,HHV-6B是一个重要的,但往往被低估的贡献者热性癫痫发作的幼儿呈现到急诊科(ED)。目的本系统综述旨在探讨儿童HHV-6感染的病毒学、流行病学和临床特征,重点关注神经学表现,同时评估当前ED的诊断方法和HHV-6检测在儿童热性惊厥中的潜在作用。方法:根据PRISMA指南,对PubMed和Embase数据库进行全面检索,确定截至2025年9月发表的关于HHV-6病毒学、皮肤病学发现、神经系统并发症和儿科患者ED管理的研究。纳入标准侧重于HHV-6在热性惊厥中的作用以及快速分子诊断在急诊科中的应用。搜索词包括与HHV-6、热性惊厥和儿科急诊相关的关键词。两名审稿人独立进行全文审查并提取数据。结果HHV-6B原发感染影响大多数2岁儿童,该组中高达30% %的首次发热性惊厥归因于该病毒。虽然大多数是自限性的,但HHV-6B与复杂的热性惊厥和热性癫痫持续状态不成比例地相关。新兴的快速诊断工具为选定的高危人群提供了有针对性的检测机会,但费用昂贵。结论shhv - 6b是一种未被充分认识的儿科热性惊厥病因。对复杂或长时间癫痫发作进行选择性筛查可提高长期预后。在更有力的证据出现之前,临床医生应该在更广泛的临床背景下解释HHV-6B的结果。
{"title":"“Systematic review of HHV-6 and febrile seizures: Should the ER include it in the viral panel?”","authors":"Valerie Foy ,&nbsp;Shaina Gagadam","doi":"10.1016/j.jcvp.2025.100233","DOIUrl":"10.1016/j.jcvp.2025.100233","url":null,"abstract":"<div><h3>Background</h3><div>Human herpesvirus 6 (HHV-6), particularly subtype B, is a common viral infection in childhood and the cause of roseola infantum. Beyond its dermatologic effects, HHV-6B is an important yet often underrecognized contributor to febrile seizures in young children presenting to the emergency department (ED).</div></div><div><h3>Objective</h3><div>This systematic review aims to examine the virology, epidemiology, and clinical features of HHV-6 infection in children, focusing on neurologic manifestations, while evaluating current ED diagnostic practices and the potential role for HHV-6 testing in pediatric febrile seizures.</div></div><div><h3>Methods</h3><div>Following PRISMA guidelines, a comprehensive search of PubMed and Embase databases identified studies published up to September 2025 on HHV-6 virology, dermatologic findings, neurologic complications, and ED management in pediatric patients. Inclusion criteria focused on HHV-6′s role in febrile seizures and the utility of rapid molecular diagnostics in the ED. Search terms included keywords related to HHV-6, febrile seizures, and pediatric emergency care. Two reviewers independently performed full-text reviews and extracted data.</div></div><div><h3>Results</h3><div>Primary HHV-6B infection affects most children by age two, with up to 30 % of first febrile seizures in this group attributed to the virus. While mostly self-limited, HHV-6B is disproportionately associated with complex febrile seizures and febrile status epilepticus. Emerging rapid diagnostic tools offer opportunities for targeted testing in select high-risk populations but are costly.</div></div><div><h3>Conclusions</h3><div>HHV-6B is an underrecognized cause of febrile seizures in pediatrics. Selective screening for complex or prolonged seizures may enhance improve long-term outcomes. Until stronger evidence emerges, clinicians should interpret HHV-6B results within the broader clinical context.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 4","pages":"Article 100233"},"PeriodicalIF":1.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145519939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of dried blood spot vs. venous sample collection on SARS-CoV-2 antibody test results in the CLSA serological study of older Canadians 在加拿大老年人里昂证券血清学研究中,干血斑与静脉标本采集对SARS-CoV-2抗体检测结果的影响
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-11-01 DOI: 10.1016/j.jcvp.2025.100236
Jiacheng Chen , Yuan Yu , Steven J. Drews , W. Alton Russell

Background

Participant-collected dried blood spots (DBS), which can be returned using regular mail, are convenient for collecting samples for population serology studies. The impact of DBS sampling on assay performance remains unclear.

Objective

We estimated the impact of using DBS samples on estimates of population SARS-CoV-2 antibody levels within a study of older Canadians.

Study Design

Analyzing data from 3 796 participants who provided DBS samples and 3 457 participants who provided venous samples, we estimated the impact of sample collection modality on odds of testing positive for anti-nucleocapsid antibodies (Anti-N) or for antibodies to the SARS-CoV-2 spike protein (Anti-S) using the Elecsys Anti-SARS-CoV-2 and Anti-SARS-CoV-2 S immunoassays. We used inverse probability of treatment weighting to control for differences between participants who provided DBS or venous samples, including sample collection date and participants’ age, vaccination status, and geographic location.

Results

Compared to venous samples, DBS samples were less likely to be Anti-N positive (weighted risk ratio [RR]: 0.30, 95 % confidence interval [CI]: 0.25–0.36) and less likely to be Anti-S positive (RR: 0.83, 95 % CI: 0.80–0.86). We estimate that using DBS for all participants would have underestimated seropositivity for anti-N antibodies (2.48 % using DBS; 8.32 % using venous) and anti-S antibodies (42.7 % using DBS; 51.6 % using venous).

Discussion

In population serology studies, DBS samples should only be used instead of venous blood draws when the impact on assay performance is well-characterized and appropriate adjustments are used to derive population seropositivity estimates.
参与者采集的干血斑(DBS)可通过普通邮件返回,便于收集人群血清学研究的样本。DBS取样对分析性能的影响尚不清楚。目的:在一项针对加拿大老年人的研究中,我们估计了使用DBS样本对估计人群SARS-CoV-2抗体水平的影响。研究设计分析了提供DBS样本的3 796名参与者和提供静脉样本的3 457名参与者的数据,我们使用Elecsys Anti-SARS-CoV-2和Anti-SARS-CoV-2 S免疫测定,估计了样本收集方式对抗核衣壳抗体(Anti-N)或抗SARS-CoV-2刺突蛋白(Anti-S)抗体检测阳性几率的影响。我们使用治疗加权逆概率来控制提供DBS或静脉样本的参与者之间的差异,包括样本收集日期和参与者的年龄、疫苗接种状况和地理位置。结果与静脉标本相比,DBS标本抗- n阳性的可能性较低(加权风险比[RR]: 0.30, 95%可信区间[CI]: 0.25 ~ 0.36),抗- s阳性的可能性较低(RR: 0.83, 95% CI: 0.80 ~ 0.86)。我们估计,对所有参与者使用DBS会低估抗n抗体(使用DBS的比例为2.48%,使用静脉的比例为8.32%)和抗s抗体(使用DBS的比例为42.7%,使用静脉的比例为51.6%)的血清阳性。在人群血清学研究中,只有当DBS样本对检测性能的影响得到充分表征,并且使用适当的调整来得出人群血清阳性估计时,才应该使用DBS样本来代替静脉血。
{"title":"Impact of dried blood spot vs. venous sample collection on SARS-CoV-2 antibody test results in the CLSA serological study of older Canadians","authors":"Jiacheng Chen ,&nbsp;Yuan Yu ,&nbsp;Steven J. Drews ,&nbsp;W. Alton Russell","doi":"10.1016/j.jcvp.2025.100236","DOIUrl":"10.1016/j.jcvp.2025.100236","url":null,"abstract":"<div><h3>Background</h3><div>Participant-collected dried blood spots (DBS), which can be returned using regular mail, are convenient for collecting samples for population serology studies. The impact of DBS sampling on assay performance remains unclear.</div></div><div><h3>Objective</h3><div>We estimated the impact of using DBS samples on estimates of population SARS-CoV-2 antibody levels within a study of older Canadians.</div></div><div><h3>Study Design</h3><div>Analyzing data from 3 796 participants who provided DBS samples and 3 457 participants who provided venous samples, we estimated the impact of sample collection modality on odds of testing positive for anti-nucleocapsid antibodies (Anti-N) or for antibodies to the SARS-CoV-2 spike protein (Anti-S) using the Elecsys Anti-SARS-CoV-2 and Anti-SARS-CoV-2 S immunoassays. We used inverse probability of treatment weighting to control for differences between participants who provided DBS or venous samples, including sample collection date and participants’ age, vaccination status, and geographic location.</div></div><div><h3>Results</h3><div>Compared to venous samples, DBS samples were less likely to be Anti-N positive (weighted risk ratio [RR]: 0.30, 95 % confidence interval [CI]: 0.25–0.36) and less likely to be Anti-S positive (RR: 0.83, 95 % CI: 0.80–0.86). We estimate that using DBS for all participants would have underestimated seropositivity for anti-N antibodies (2.48 % using DBS; 8.32 % using venous) and anti-S antibodies (42.7 % using DBS; 51.6 % using venous).</div></div><div><h3>Discussion</h3><div>In population serology studies, DBS samples should only be used instead of venous blood draws when the impact on assay performance is well-characterized and appropriate adjustments are used to derive population seropositivity estimates.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 4","pages":"Article 100236"},"PeriodicalIF":1.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145684125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Systemic reactogenicity is a correlate of MF59 adjuvant-moderated immunogenicity in influenza vaccinated children 流感疫苗接种儿童的全身反应原性与MF59佐剂调节的免疫原性相关
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-11-01 DOI: 10.1016/j.jcvp.2025.100234
Charlotte Switzer , Chris P. Verschoor , Eleanor Pullenayegum , Pardeep Singh , Mark Loeb

Background

Adjuvanted influenza vaccine induces more robust antibody responses, but is associated with more adverse events following vaccination. Prior work has examined the link between vaccine reactions and immunogenicity in adults, but little is known about the association between reactogenicity and postvaccination antibody responses in children, particularly regarding adjuvanted influenza vaccine. This study examines the relationship between reactogenicity and immunogenicity in children vaccinated against influenza, and the immunomodulatory effects of the adjuvant.

Methods

We conducted a secondary analysis of data from a cluster-randomized trial of children aged 6 to 72 months from Canadian Hutterite colonies. Participants received either a trivalent MF59-adjuvanted vaccine (aTIV) or a quadrivalent non-adjuvanted vaccine (QIV). Reactogenicity was measured using a composite score based on local, systemic, and respiratory reactions recorded within five days post-vaccination. Immunogenicity was assessed by measuring hemagglutination inhibition (HAI) titers before and four weeks after vaccination. Linear mixed models were used to evaluate associations between reactogenicity scores and post-vaccination log-transformed HAI titers.

Results

In adjuvanted vaccinees, higher systemic reactogenicity scores were associated with increased antibody titers for A/H1N1 and B/Victoria, relative to nonadjuvanted vaccinees (β: 0.38, 95 % CI: 0.17 to 0.60; and (β: 0.44, 95 % CI: 0.24 to 0.64 respectively). Higher systemic reactogenicity in nonadjuvanted vaccinees correlated with reduced post-vaccination antibody titers for A/H1N1 (β:0.36, 95 % CI:0.54 to -0.18) and B/Victoria (β:0.37, 95 % CI:0.54 to -0.20). Respiratory reactogenicity was positively correlated with immunogenicity in responses to A/H3N2 in the adjuvanted group (β: 0.78, 95 % CI: 0.13 to 1.43). Local reactogenicity was associated with A/H1N1 immunogenicity, but showed no significant interaction with vaccine formulation (β: 0.25, 95 % CI: 0.04 to 0.47).

Conclusions

Systemic reactogenicity in adjuvanted vaccinees showed positive correlations with immunogenicity, whereas reactogenicity contributed to blunting of antibody responses in nonadjuvanted vaccinees. We found that stronger systemic reactions correlate with improved immune responses in the adjuvanted group against all vaccine strains save A/H3N2, which warrants further investigation. Our study finds that reactogenicity is a modest biomarker for vaccine immunogenicity, and that the increased reactogenicity of the adjuvanted vaccine is associated with enhanced immune responsiveness, which may predict greater vaccine effectiveness.
背景:佐剂流感疫苗可诱导更强的抗体应答,但在接种后与更多不良事件相关。先前的工作已经研究了成人疫苗反应与免疫原性之间的联系,但对儿童疫苗反应原性与疫苗接种后抗体反应之间的关系知之甚少,特别是关于佐剂流感疫苗。本研究探讨儿童接种流感疫苗的反应原性和免疫原性之间的关系,以及佐剂的免疫调节作用。方法我们对来自加拿大huterite殖民地的6至72个月儿童的集群随机试验数据进行了二次分析。参与者接受三价mf59佐剂疫苗(aTIV)或四价非佐剂疫苗(QIV)。使用基于接种后5天内记录的局部、全身和呼吸反应的综合评分来测量反应原性。免疫原性通过测定疫苗接种前和接种后四周的血凝抑制(HAI)滴度来评估。使用线性混合模型来评估反应性评分与接种后对数转换的HAI滴度之间的关系。结果在接种佐剂疫苗的人群中,与未接种佐剂疫苗的人群相比,更高的系统反应原性评分与更高的A/H1N1和B/Victoria抗体滴度相关(β: 0.38, 95% CI: 0.17 ~ 0.60; β: 0.44, 95% CI: 0.24 ~ 0.64)。非佐剂疫苗接种者较高的全身反应原性与疫苗接种后A/H1N1抗体滴度(β:0.36, 95% CI:0.54至-0.18)和B/Victoria抗体滴度(β:0.37, 95% CI:0.54至-0.20)降低相关。A/H3N2佐剂组呼吸反应原性与免疫原性呈正相关(β: 0.78, 95% CI: 0.13 ~ 1.43)。局部反应原性与A/H1N1免疫原性相关,但与疫苗制剂无显著相互作用(β: 0.25, 95% CI: 0.04 ~ 0.47)。结论佐剂疫苗接种者的全身反应原性与免疫原性呈正相关,而非佐剂疫苗接种者的全身反应原性与抗体反应钝化有关。我们发现,在佐剂组中,更强的全身反应与对除A/H3N2以外的所有疫苗株的免疫反应改善相关,这值得进一步研究。我们的研究发现,反应原性是疫苗免疫原性的适度生物标志物,佐剂疫苗反应原性的增加与免疫反应性的增强有关,这可能预示着更大的疫苗有效性。
{"title":"Systemic reactogenicity is a correlate of MF59 adjuvant-moderated immunogenicity in influenza vaccinated children","authors":"Charlotte Switzer ,&nbsp;Chris P. Verschoor ,&nbsp;Eleanor Pullenayegum ,&nbsp;Pardeep Singh ,&nbsp;Mark Loeb","doi":"10.1016/j.jcvp.2025.100234","DOIUrl":"10.1016/j.jcvp.2025.100234","url":null,"abstract":"<div><h3>Background</h3><div>Adjuvanted influenza vaccine induces more robust antibody responses, but is associated with more adverse events following vaccination. Prior work has examined the link between vaccine reactions and immunogenicity in adults, but little is known about the association between reactogenicity and postvaccination antibody responses in children, particularly regarding adjuvanted influenza vaccine. This study examines the relationship between reactogenicity and immunogenicity in children vaccinated against influenza, and the immunomodulatory effects of the adjuvant.</div></div><div><h3>Methods</h3><div>We conducted a secondary analysis of data from a cluster-randomized trial of children aged 6 to 72 months from Canadian Hutterite colonies. Participants received either a trivalent MF59-adjuvanted vaccine (aTIV) or a quadrivalent non-adjuvanted vaccine (QIV). Reactogenicity was measured using a composite score based on local, systemic, and respiratory reactions recorded within five days post-vaccination. Immunogenicity was assessed by measuring hemagglutination inhibition (HAI) titers before and four weeks after vaccination. Linear mixed models were used to evaluate associations between reactogenicity scores and post-vaccination log-transformed HAI titers.</div></div><div><h3>Results</h3><div>In adjuvanted vaccinees, higher systemic reactogenicity scores were associated with increased antibody titers for A/H1N1 and B/Victoria, relative to nonadjuvanted vaccinees (β: 0.38, 95 % CI: 0.17 to 0.60; and (β: 0.44, 95 % CI: 0.24 to 0.64 respectively). Higher systemic reactogenicity in nonadjuvanted vaccinees correlated with reduced post-vaccination antibody titers for A/H1N1 (β:0.36, 95 % CI:0.54 to -0.18) and B/Victoria (β:0.37, 95 % CI:0.54 to -0.20). Respiratory reactogenicity was positively correlated with immunogenicity in responses to A/H3N2 in the adjuvanted group (β: 0.78, 95 % CI: 0.13 to 1.43). Local reactogenicity was associated with A/H1N1 immunogenicity, but showed no significant interaction with vaccine formulation (β: 0.25, 95 % CI: 0.04 to 0.47).</div></div><div><h3>Conclusions</h3><div>Systemic reactogenicity in adjuvanted vaccinees showed positive correlations with immunogenicity, whereas reactogenicity contributed to blunting of antibody responses in nonadjuvanted vaccinees. We found that stronger systemic reactions correlate with improved immune responses in the adjuvanted group against all vaccine strains save A/H3N2, which warrants further investigation. Our study finds that reactogenicity is a modest biomarker for vaccine immunogenicity, and that the increased reactogenicity of the adjuvanted vaccine is associated with enhanced immune responsiveness, which may predict greater vaccine effectiveness.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 4","pages":"Article 100234"},"PeriodicalIF":1.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145465301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The immunogenicity of recombinant zoster vaccination in patients with secondary immunodeficiencies: a literature review 重组带状疱疹疫苗对继发性免疫缺陷患者的免疫原性:文献综述
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2025-10-07 DOI: 10.1016/j.jcvp.2025.100231
Stascha I. Kuipers , Marjolein Knoester , Carin L.E. Hazenberg , Debbie van Baarle , Marieke van der Heiden
Herpes zoster (HZ), caused by reactivation of the varicella zoster virus, is characterized by painful rashes and severe complications. Immunocompromised individuals are at greater risk of developing HZ. Vaccination with the novel recombinant adjuvanted zoster subunit vaccine (RZV) proved highly effective in older adults and is considered safe in patients with secondary immunodeficiencies. This review summarizes the current evidence on efficacy and immunogenicity of RZV in patients with secondary immunodeficiencies and identifies factors associated with reduced immunogenicity.
RZV is highly immunogenic in patients with HIV and most haematological malignancies. Reduced responsiveness has been observed in patients with solid tumours, chronic lymphocytic leukaemia, non-Hodgkin B-cell lymphoma, autologous haematopoietic cell transplants, and solid organ transplants. Reduced response is associated with Rituximab and post-transplantation immunosuppressive treatments, as well as immunosuppressive effects of solid tumours and chemotherapy. Future research should investigate whether personalised vaccination schedules, guided by biomarkers for immune function and treatment and/or transplantation schedules, may improve RZV responsiveness.
带状疱疹(HZ)是由水痘带状疱疹病毒再激活引起的,其特征是疼痛的皮疹和严重的并发症。免疫功能低下的个体患HZ的风险更大。事实证明,新型重组佐剂带状疱疹亚单位疫苗(RZV)在老年人中非常有效,并且被认为对继发性免疫缺陷患者是安全的。本文综述了目前关于RZV对继发性免疫缺陷患者的疗效和免疫原性的证据,并确定了与免疫原性降低相关的因素。RZV在HIV和大多数血液恶性肿瘤患者中具有高度免疫原性。在实体肿瘤、慢性淋巴细胞白血病、非霍奇金b细胞淋巴瘤、自体造血细胞移植和实体器官移植患者中观察到反应性降低。反应降低与利妥昔单抗和移植后免疫抑制治疗以及实体瘤和化疗的免疫抑制作用有关。未来的研究应该调查在免疫功能生物标志物和治疗和/或移植计划的指导下,个性化的疫苗接种计划是否可以改善RZV反应性。
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Journal of clinical virology plus
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