Journal of clinical virology plus最新文献

{"title":"Multicenter performance evaluation of the Atellica IM HBcT2 immunoassay for risk or symptom-driven hepatitis B core antibody testing","authors":"Matthew F.W. Gee ,&nbsp;Maria Pagano ,&nbsp;Marie-Elena Grosett ,&nbsp;Brendan Healy ,&nbsp;Sara Kastrup Shah ,&nbsp;Eugene R. Schiff","doi":"10.1016/j.jcvp.2026.100244","DOIUrl":"10.1016/j.jcvp.2026.100244","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"6 2","pages":"Article 100244"},"PeriodicalIF":1.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146192014","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}

{"title":"Clinical evaluation of the BD Veritor™ SARS-CoV-2 point-of-care test","authors":"Jesse Young ,&nbsp;Ashley Orlowski ,&nbsp;Karen Yanson ,&nbsp;Katherine Christensen","doi":"10.1016/j.jcvp.2026.100242","DOIUrl":"10.1016/j.jcvp.2026.100242","url":null,"abstract":"<div><h3>BACKGROUND</h3><div>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.</div></div><div><h3>OBJECTIVE</h3><div>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.</div></div><div><h3>METHODS</h3><div>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.</div></div><div><h3>RESULTS</h3><div>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.</div></div><div><h3>CONCLUSION</h3><div>The Veritor test allows rapid and accurate detection of SARS-CoV-2 antigen testing utilizing easy-to-collect nasal swabs.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"6 2","pages":"Article 100242"},"PeriodicalIF":1.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146192012","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}

{"title":"Strengthening cross-border preparedness for re-emerging Nipah virus threats in Asia: prevention and global health security","authors":"Mohamed Mustaf Ahmed ,&nbsp;Shuaibu Saidu Musa ,&nbsp;Zhinya Kawa Othman ,&nbsp;Christian Joseph N. Ong ,&nbsp;Don Eliseo Lucero-Prisno III","doi":"10.1016/j.jcvp.2026.100243","DOIUrl":"10.1016/j.jcvp.2026.100243","url":null,"abstract":"","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"6 2","pages":"Article 100243"},"PeriodicalIF":1.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146102938","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}

{"title":"Viral haemorrhagic fever (Marburg) outbreak in Ethiopia: global health response and preparedness lessons for East Africa","authors":"Mohamed Mustaf Ahmed ,&nbsp;Eilham Elias Jobir ,&nbsp;Abdirasak Sharif Ali","doi":"10.1016/j.jcvp.2025.100238","DOIUrl":"10.1016/j.jcvp.2025.100238","url":null,"abstract":"","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"6 1","pages":"Article 100238"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145799607","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}

{"title":"Global mpox is declining, but clade Ib is spreading: A call for vigilance","authors":"Safayet Jamil ,&nbsp;Uthman Okikiola Adebayo ,&nbsp;Alok Bhatt ,&nbsp;Pentela Bhavani ,&nbsp;Ashwinikumar Sapate ,&nbsp;Fayaz Ahamed","doi":"10.1016/j.jcvp.2026.100241","DOIUrl":"10.1016/j.jcvp.2026.100241","url":null,"abstract":"","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"6 1","pages":"Article 100241"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146037992","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}

{"title":"Clinical performance of the BD Respiratory Viral Panel – SCV2 for BD MAX™ system with nasopharyngeal and anterior nasal specimens","authors":"Sonia Paradis ,&nbsp;Barbara Van Der Pol ,&nbsp;Thomas E. Davis ,&nbsp;Nathan A. Ledeboer ,&nbsp;Matthew L. Faron ,&nbsp;William Laviers ,&nbsp;Jeffry Leitch ,&nbsp;Elizabeth Lockamy ,&nbsp;Karen A. Yanson","doi":"10.1016/j.jcvp.2025.100237","DOIUrl":"10.1016/j.jcvp.2025.100237","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 %.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"6 1","pages":"Article 100237"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145926815","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}

{"title":"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”","authors":"Sushma Narsing Katkuri ,&nbsp;Varshini Vadhithala ,&nbsp;Arun Kumar ,&nbsp;Sushma Verma ,&nbsp;Dhanya Dedeepya","doi":"10.1016/j.jcvp.2025.100239","DOIUrl":"10.1016/j.jcvp.2025.100239","url":null,"abstract":"","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"6 1","pages":"Article 100239"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145749978","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}

{"title":"Prevalence and characteristics of Hepatitis B and other transfusion-transmitted infections among blood donors in Albania: Implications for blood safety and screening strategies","authors":"Albana Gjyzari ,&nbsp;Irini Kasolli ,&nbsp;Irena Seferi ,&nbsp;Ariana Strakosha ,&nbsp;Ergys Ramosacaj ,&nbsp;Esmeralda Thoma ,&nbsp;Admir Nake ,&nbsp;Altea Gjyzari ,&nbsp;Drieda Zaçe","doi":"10.1016/j.jcvp.2025.100240","DOIUrl":"10.1016/j.jcvp.2025.100240","url":null,"abstract":"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Methods</h3><div>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 &gt;2 × ULN were included. Demographic and clinical data collected comprised age, gender, region, education level, blood type, BMI, and ALT values.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"6 1","pages":"Article 100240"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145926919","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}

{"title":"Human papillomavirus vaccination and screening in GCC countries: Review of current status, challenges, and future directions","authors":"Lama Alzamil","doi":"10.1016/j.jcvp.2025.100235","DOIUrl":"10.1016/j.jcvp.2025.100235","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 4","pages":"Article 100235"},"PeriodicalIF":1.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145465300","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}

{"title":"The immunogenicity of recombinant zoster vaccination in patients with secondary immunodeficiencies: a literature review","authors":"Stascha I. Kuipers ,&nbsp;Marjolein Knoester ,&nbsp;Carin L.E. Hazenberg ,&nbsp;Debbie van Baarle ,&nbsp;Marieke van der Heiden","doi":"10.1016/j.jcvp.2025.100231","DOIUrl":"10.1016/j.jcvp.2025.100231","url":null,"abstract":"<div><div>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.</div><div>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.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 4","pages":"Article 100231"},"PeriodicalIF":1.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145266557","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}