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Multicenter performance evaluation of the Atellica IM HBcT2 immunoassay for risk or symptom-driven hepatitis B core antibody testing Atellica IM HBcT2免疫测定用于风险或症状驱动型乙型肝炎核心抗体检测的多中心性能评估
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2026-06-01 Epub Date: 2026-02-07 DOI: 10.1016/j.jcvp.2026.100244
Matthew F.W. Gee , Maria Pagano , Marie-Elena Grosett , Brendan Healy , Sara Kastrup Shah , Eugene R. Schiff

Background

Hepatitis B virus (HBV) causes major liver disease and despite widespread vaccination, HBV infection, often asymptomatic, remains a global health issue. Serological detection of HBV biomarkers, including total antibodies (IgM and IgG) to hepatitis B core antigen (HBc) is recommended as a first step for diagnosis and infection status assessment. The aim of our study was to evaluate the performance characteristics of the improved automated Atellica IM HBcT2 assay designed to detect total anti-HBc responses without a retest zone.

Methods

Reproducibility, clinical performance, and seroconversion studies were performed at three U.S. sites. Clinical performance testing included: 1751 prospective (pediatric, adult) specimens, representing U.S. populations across the lifespan at risk or symptomatic of HBV disease. Positive percent agreement (PPA) and negative percent agreement (NPA) for the Atellica IM HBcT2 assay were assessed against the reference Abbott ARCHITECT CORE assay. Analytical correlation was evaluated by regression analysis.

Results

The assay demonstrated robust reproducibility with %CV ≤10 % for samples ≥0.80 Index. Qualitative agreement between methods was excellent in the population overall as well as most HBV status categories (overall PPA=98 %, NPA=99 %). A high quantitative agreement was observed (slope, 0.89; Pearson’s r, 0.914). Seroconversion results showed that changes in anti-HBc total concentration of Atellica IM HBcT2 closely matched those of ARCHITECT CORE.

Conclusion

The Atellica IM HBcT2 assay on the Atellica IM analyzer demonstrated reliable clinical performance for detecting total anti-HBc antibodies, supporting its suitability for risk or symptom-driven testing in the diagnosis of HBV infection.
乙型肝炎病毒(HBV)引起严重的肝脏疾病,尽管广泛接种疫苗,HBV感染通常无症状,仍然是一个全球性的健康问题。血清学检测HBV生物标志物,包括乙型肝炎核心抗原(HBc)的总抗体(IgM和IgG),建议作为诊断和感染状态评估的第一步。本研究的目的是评估改进的自动化Atellica IM HBcT2检测的性能特征,该检测旨在检测总抗- hbc反应,无需重新测试区。方法在美国三个地点进行了重复性、临床表现和血清转化研究。临床性能测试包括:1751个前瞻性(儿童和成人)样本,代表美国人群在整个生命周期中有HBV疾病风险或症状。将Atellica IM HBcT2检测的阳性同意率(PPA)和阴性同意率(NPA)与参考Abbott ARCHITECT CORE检测进行比较。通过回归分析评价分析相关性。结果对于≥0.80指数的样品,该方法重复性强,%CV≤10%。在总体人群和大多数HBV状态类别中,两种方法的定性一致性非常好(总体PPA= 98%, NPA= 99%)。观察到高度的定量一致性(斜率为0.89;Pearson’s r为0.914)。血清转化结果显示,Atellica IM HBcT2的抗hbc总浓度变化与ARCHITECT CORE的变化密切相关。结论Atellica IM分析仪上的Atellica IM HBcT2检测在检测总抗hbc抗体方面具有可靠的临床性能,支持其在HBV感染诊断中的风险或症状驱动检测的适用性。
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引用次数: 0
Clinical evaluation of the BD Veritor™ SARS-CoV-2 point-of-care test BD Veritor™SARS-CoV-2护理点检测的临床评价
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2026-06-01 Epub Date: 2026-02-02 DOI: 10.1016/j.jcvp.2026.100242
Jesse Young , Ashley Orlowski , Karen Yanson , Katherine Christensen

BACKGROUND

Whereas COVID-19 is now in the endemic phase, maintaining robust diagnostic capabilities remains critical for ongoing surveillance and timely response to potential infection spikes.

OBJECTIVE

To evaluate the performance of the updated BD Veritor™ System for SARS-CoV-2 (Veritor; Becton Dickinson and Company, BD Life Sciences—Diagnostic Solutions, San Diego, CA ) assay against a comparator, the Panther Fusion (Fusion; Hologic Inc., San Diego, CA) and regulatory performance criteria.

METHODS

This prospective, clinical study enrolled 1,181 SARS-CoV-2 symptomatic individuals across 15 U.S. sites. Healthcare providers collected dual nares samples from participants ≥6 months of age and ≤7 days from symptom onset (DSO) to determine diagnostic accuracy of Veritor compared to Fusion and expected regulatory performance criteria per previously cleared SARS-CoV-2 antigen assays.

RESULTS

Of 1,045 compliant and reportable specimens, Veritor had an overall positive percent agreement (PPA) of 83.4% [95% CI; 76.6, 88.6] and a negative percent agreement (NPA) of 99.7% [95% CI; 99.0, 99.9]. Performance varied by DSO, with higher PPA closer to symptom onset, and by viral load (characterized by Fusion Ct score), with lower Ct scores associated with better Veritor performance. Veritor met the regulatory (FDA 510(k)) acceptance criteria for SARS-CoV-2 antigen testing for the 0-7 DSO range.

CONCLUSION

The Veritor test allows rapid and accurate detection of SARS-CoV-2 antigen testing utilizing easy-to-collect nasal swabs.
鉴于COVID-19目前处于流行阶段,保持强大的诊断能力对于持续监测和及时应对潜在的感染高峰仍然至关重要。目的评估更新后的BD Veritor™SARS-CoV-2检测系统(Veritor; Becton Dickinson and Company, BD Life Sciences-Diagnostic Solutions, San Diego, CA)与比较物Panther Fusion (Fusion; Hologic Inc., San Diego, CA)的性能和监管性能标准。这项前瞻性临床研究在美国15个地点招募了1181名有SARS-CoV-2症状的个体。医疗保健提供者从年龄≥6个月且症状发作(DSO)≤7天的参与者中收集双鼻样本,以确定Veritor与Fusion的诊断准确性,并根据先前清除的SARS-CoV-2抗原检测确定预期的监管性能标准。结果在1045例符合要求和可报告的标本中,Veritor的总体阳性满意率(PPA)为83.4% [95% CI;76.6, 88.6]和负百分比协议(NPA)为99.7% [95% CI;99.0、99.9)。表现因DSO而异,PPA越高越接近症状发作,病毒载量(以Fusion Ct评分为特征)也不同,Ct评分越低Veritor表现越好。Veritor符合0-7 DSO范围内SARS-CoV-2抗原检测的监管(FDA 510(k))接受标准。结论Veritor试验可以快速、准确地检测出SARS-CoV-2抗原,且易于收集鼻拭子。
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引用次数: 0
Strengthening cross-border preparedness for re-emerging Nipah virus threats in Asia: prevention and global health security 加强跨界防范以应对亚洲再次出现的尼帕病毒威胁:预防和全球卫生安全
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2026-06-01 Epub Date: 2026-02-01 DOI: 10.1016/j.jcvp.2026.100243
Mohamed Mustaf Ahmed , Shuaibu Saidu Musa , Zhinya Kawa Othman , Christian Joseph N. Ong , Don Eliseo Lucero-Prisno III
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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 : 2026-02-01 Epub 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
Global mpox is declining, but clade Ib is spreading: A call for vigilance 全球麻疹正在下降,但b支正在蔓延:警惕的呼吁
IF 1.4 Q4 INFECTIOUS DISEASES Pub Date : 2026-02-01 Epub Date: 2026-01-04 DOI: 10.1016/j.jcvp.2026.100241
Safayet Jamil , Uthman Okikiola Adebayo , Alok Bhatt , Pentela Bhavani , Ashwinikumar Sapate , Fayaz Ahamed
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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 : 2026-02-01 Epub 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 : 2026-02-01 Epub 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
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 : 2026-02-01 Epub 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
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 Epub Date: 2025-10-31 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
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 : 2025-11-01 Epub 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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引用次数: 0
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Journal of clinical virology plus
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