Journal of Clinical Virology最新文献_第3页

A series of diagnostic contamination events from seasonal influenza vaccines 季节性流感疫苗的一系列诊断性污染事件。

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2026-02-01 Epub Date: 2026-01-10 DOI: 10.1016/j.jcv.2026.105912

Andreas Rohringer , Marit H. Ebbesen , Even Fossum , Randi M. Nygaard , Birgitte B. Madsen , Margrethe Storm , Nina Aasand , Kjersti Rydland , Karoline Bragstad , Olav Hungnes

{"title":"A series of diagnostic contamination events from seasonal influenza vaccines","authors":"Andreas Rohringer , Marit H. Ebbesen , Even Fossum , Randi M. Nygaard , Birgitte B. Madsen , Margrethe Storm , Nina Aasand , Kjersti Rydland , Karoline Bragstad , Olav Hungnes","doi":"10.1016/j.jcv.2026.105912","DOIUrl":"10.1016/j.jcv.2026.105912","url":null,"abstract":"<div><h3>Background</h3><div>Polymerase chain reaction (PCR) is preferred for diagnosing influenza, allowing differentiation between influenza A and B viruses and their subtypes/lineages. However, PCR's high sensitivity can lead to false positives from contamination. During the 2022–2023 influenza season in Norway, a pattern of diagnostic samples testing positive for both influenza A and B or the presumably extinct B/Yamagata lineage suggested external contamination.</div></div><div><h3>Methods</h3><div>We conducted PCR testing for these samples, environmental samples from vaccination sites, and vaccines, alongside a retrospective review of test data.</div></div><div><h3>Results</h3><div>This review revealed an increased frequency of unusual detection patterns, particularly during weeks 42–46 of 2022, aligning with the peak of the vaccination campaign. During this period, suspected vaccine-contaminated samples comprised 3.45 % of all influenza-positive samples. Environmental sampling at vaccination sites confirmed the presence of influenza A and B RNA, supporting suspicion of vaccine-derived contamination. Detection in suspect diagnostic specimens of multiple influenza types/subtypes/lineages, including the extinct B/Yamagata lineage, corroborated the seasonal influenza vaccine's contamination source.</div></div><div><h3>Conclusion</h3><div>These findings highlight the risk of diagnostic sample contamination with RNA from influenza virion-derived vaccines, impacting diagnostic accuracy and public health surveillance.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105912"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145966279","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

Comparative performance of the Siemens Atellica and Abbott Architect assays for HBsAg quantification in patients with chronic hepatitis B or hepatitis Delta 西门子Atellica和雅培Architect测定慢性乙型肝炎或丁型肝炎患者HBsAg定量的比较性能

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2026-02-01 Epub Date: 2026-01-16 DOI: 10.1016/j.jcv.2026.105913

Léonie Badot , Marie-Noëlle Hilleret , Dorra Guergour , Carole Chirica , Aurélie Truffot , Patrice Morand , Raphaële Germi , Caroline Scholtès , Sylvie Larrat , Julien Lupo

{"title":"Comparative performance of the Siemens Atellica and Abbott Architect assays for HBsAg quantification in patients with chronic hepatitis B or hepatitis Delta","authors":"Léonie Badot , Marie-Noëlle Hilleret , Dorra Guergour , Carole Chirica , Aurélie Truffot , Patrice Morand , Raphaële Germi , Caroline Scholtès , Sylvie Larrat , Julien Lupo","doi":"10.1016/j.jcv.2026.105913","DOIUrl":"10.1016/j.jcv.2026.105913","url":null,"abstract":"<div><h3>Background</h3><div>Quantitative hepatitis B surface antigen (qHBsAg) is a routine marker for monitoring patients with chronic hepatitis B (CHB) or Delta (CHD). New commercially available assays require independent evaluation in clinical laboratories before being adopted for routine use. This study assessed the performance of the new Siemens Atellica IM Quantitative HBsAg (QHBs) assay in patients with CHB or CHD.</div></div><div><h3>Methods</h3><div>Over a six-month period, all serum specimens from patients with CHB or CHD that were submitted to the laboratory for qHBsAg testing were prospectively analyzed using both the historically used Architect assay and the new Atellica assay. Furthermore, in a retrospective longitudinal analysis, we examined CHD patients who showed a reduction of at least 1 log<sub>10</sub> UI/mL in HBsAg levels over the course of treatment.</div></div><div><h3>Results</h3><div>A total of 311 serum samples from 216 patients were prospectively evaluated. The Architect assay yielded slightly higher values than the Atellica assay (mean difference: +0.10 log₁₀ IU/mL). There was excellent agreement and correlation between the two assays (Spearman’s Rs = 0.99; 95 % CI [0.9877–0.9922]). Three samples with low HBsAg concentrations (0.02–0.07 IU/mL) were detected by the Atellica assay but not by the Architect assay. In the longitudinal follow-up of five CHD patients (82 samples), both assays produced comparable results and could be used interchangeably without any potential clinical impact.</div></div><div><h3>Conclusion</h3><div>The Atellica assay demonstrated equivalent performance to the Architect assay for qHBsAg monitoring in patients with CHB or CHD.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105913"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977095","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

Peptide-assisted direct detection of HPV nucleic acids from liquid-based cytology samples without extraction 多肽辅助直接检测HPV核酸液基细胞学样品，无需提取。

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2026-02-01 Epub Date: 2025-11-29 DOI: 10.1016/j.jcv.2025.105901

Sadia Almas , Salima Karki , Rob E. Carpenter , Vaibhav K. Tamrakar , Aditya Sharma , Kamalpreet Suri , Rahul Sharma

{"title":"Peptide-assisted direct detection of HPV nucleic acids from liquid-based cytology samples without extraction","authors":"Sadia Almas , Salima Karki , Rob E. Carpenter , Vaibhav K. Tamrakar , Aditya Sharma , Kamalpreet Suri , Rahul Sharma","doi":"10.1016/j.jcv.2025.105901","DOIUrl":"10.1016/j.jcv.2025.105901","url":null,"abstract":"<div><div>High-risk human papillomavirus remains the causal agent of nearly all cervical cancers. And we need tools for rapid detection that work in routinely taken samples (e.g., PreservCyt®) that can speed up, facilitate or simplify the extraction process. Conventional workflows rely on nucleic-acid extraction, a cost- and labor-intensive step that restricts scalability in both high-throughput and resource-limited settings. Here, we introduce MDP-1, a rationally designed peptide that represents the prototype of a new class of <em>capsid-targeted diagnostic enhancers</em>. Unlike antimicrobial peptides historically developed for therapeutic membrane lysis, MDP-1 was engineered to bind the HPV L1 major capsid protein, interfere with L1–L1 interactions, and promote partial capsid destabilization to enhance genome accessibility. In silico docking demonstrated favorable binding (HADDOCK score –173.4 ± 6.2; BSA 1958 ± 83.9 Å²; RMSD 1.8 ± 0.1 Å) with extensive electrostatic and hydrophobic complementarity. When integrated into a direct-to-PCR workflow, MDP-1 enabled robust amplification from unextracted PreservCyt® specimens, maintaining efficiencies within 90–110 % and achieving a limit of detection of 1.25 copies/µL. Analytical specificity testing confirmed no cross-reactivity, while interference studies showed tolerance to common clinical inhibitors. In a feasibility cohort (<em>n</em> = 53), the MDP-1 workflow achieved 93.5 % sensitivity (95 % CI: 78.6–99.2) and 99.3 % specificity (95 % CI: 85.4–99.9) for the detection of high-risk HPV DNA, with an overall accuracy of 98.5 % compared to extraction-based qPCR and strongly correlated Ct values (R² = 0.772). This proof-of-concept positions MDP-1 as a first-in-class tool that recasts HPV diagnostics by leveraging peptide–virion interactions to bypass inhibitors and eliminate timely and costly extraction workflows.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105901"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145661204","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

The prognostic potential of fetal platelet count and viral load in prenatal cytomegalovirus infection: A retrospective cohort of 74 cases 胎儿血小板计数和病毒载量在产前巨细胞病毒感染中的预后潜力：74例回顾性队列

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2026-02-01 Epub Date: 2025-12-17 DOI: 10.1016/j.jcv.2025.105909

Caroline De Coninck , Megane Bellemans , Marie-Luce Delforge , Elena Costa , Catherine Donner

{"title":"The prognostic potential of fetal platelet count and viral load in prenatal cytomegalovirus infection: A retrospective cohort of 74 cases","authors":"Caroline De Coninck , Megane Bellemans , Marie-Luce Delforge , Elena Costa , Catherine Donner","doi":"10.1016/j.jcv.2025.105909","DOIUrl":"10.1016/j.jcv.2025.105909","url":null,"abstract":"<div><h3>Background</h3><div>Congenital cytomegalovirus (CMV) infection is the most common congenital infection and a leading cause of childhood deafness and neurological impairment. Prenatal prognosis depends on gestational age at maternal infection, infection type, fetal brain imaging (ultrasound and MRI), and fetal blood markers such as viral load (VL) and platelet (plt) count.</div></div><div><h3>Objectives</h3><div>We aimed to evaluate the prognostic value of two fetal blood markers — CMV VL and plt count — for fetal, neonatal, and long-term outcomes.</div></div><div><h3>Study design</h3><div>This retrospective cohort study included 74 cases of cordocentesis performed between 2001 and 2021 at CUB-Hôpital Erasme and CHIREC hospitals in Brussels.</div></div><div><h3>Results</h3><div>Of the 74 infections, 52 occurred in the first trimester, 20 in the second and 2 in the third. Twenty-one pregnancies were terminated (19 first trimester, 2 s trimester). Severe brain abnormalities on antenatal imaging were significantly associated with being symptomatic at birth (OR 24.5; CI 2.69 – 223.34; p = 0.01) and during follow-up (OR 30.75; CI 4.59 – 205.86; p = 0,00). A fetal platelet count below 100.000/mm³ increased the risk of severe cerebral lesions (OR 2.59; CI 1.09 – 14.28; p = 0.04), but neither VL nor plt count alone correlated significantly with clinical symptoms at birth or later. The positive predictive value for being symptomatic at birth increased from 87.5 % to 100 % when severe imaging abnormalities were combined with VL ≥ 50.000 copies/ml and a plt count < 100.000/mm³ .</div></div><div><h3>Conclusion</h3><div>In our study, cordocentesis assessing VL and plt count appears to provide limited additional prognostic information beyond severe antenatal brain imaging in fetuses with congenital CMV infection.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105909"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145880097","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

Primary Epstein–Barr virus infection in preadolescent children: A prospective study 青春期前儿童原发性eb病毒感染：一项前瞻性研究

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2025-12-01 Epub Date: 2025-08-31 DOI: 10.1016/j.jcv.2025.105859

Laurel E. Cederberg , Jennifer M. Geris , Mee Chang , Arianna L. Stancari , Andrew J. Klump , Lawrence M. Condon , Gabriel C. Cederberg , Henry H. Balfour Jr.

{"title":"Primary Epstein–Barr virus infection in preadolescent children: A prospective study","authors":"Laurel E. Cederberg , Jennifer M. Geris , Mee Chang , Arianna L. Stancari , Andrew J. Klump , Lawrence M. Condon , Gabriel C. Cederberg , Henry H. Balfour Jr.","doi":"10.1016/j.jcv.2025.105859","DOIUrl":"10.1016/j.jcv.2025.105859","url":null,"abstract":"<div><h3>Importance</h3><div>Epstein–Barr virus (EBV) is not only the principal cause of infectious mononucleosis (IM) but is also a precursor to several cancers and autoimmune disorders. Access to a prophylactic EBV vaccine early in life could be key for the prevention of these conditions. However, the incidence of primary EBV infection (pEBV) in preadolescent children is not currently known. We hypothesized that pEBV is clinically significant, but often undiagnosed.</div></div><div><h3>Methods</h3><div>In this prospective study we screened and followed preadolescent children ages 1.5–11.99 years at a single pediatric primary care clinic to determine incidence of pEBV. Using oral swabs to collect gingival crevicular fluid, we screened participants for the presence of EBV IgG antibody against viral capsid antigen. Participants who lacked EBV antibody (EBV-naïve) were enrolled in the prospective arm of the study with screening for oral EBV antibody every 3 months.</div></div><div><h3>Results</h3><div>Of 291 children screened, 210 (72.2 %) were EBV-naïve. Of those, 181 (86 %) were enrolled in the prospective study. During 119.8 person-years of participant observation, 11 cases of pEBV were documented. Five cases were symptomatic. The incidence of pEBV was 9.2 cases/100 person-years. Self-identified Asian, Black, and Latino children had greater incidence of pEBV relative to self-identified White children.</div></div><div><h3>Conclusions</h3><div>We show that the incidence of pEBV in preadolescents is higher than that of other infectious diseases with disease burdens so severe that vaccines have been used for decades to prevent their spread, but diagnosis of pEBV is often missed by parents and clinicians. This study provides a rationale to administer EBV vaccine to preadolescents. EBV is the only infectious agent assessed in the study.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"Article 105859"},"PeriodicalIF":3.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145026328","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

Serological analysis of COVID-19 patients highlights cross-reactivity of antibodies with the HIV-1 2F5 epitope COVID-19患者的血清学分析强调了与hiv - 12f5表位的抗体的交叉反应性

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2025-12-01 Epub Date: 2025-10-10 DOI: 10.1016/j.jcv.2025.105880

Tayná E. Lima , Carlos A.A. Brito , Laura H.V.G. Gil , Rafael Dhalia , Franciane M.E. Teixeira , Maria N. Sato , Gabriel L. Wallau , Roberto D. Lins , Isabelle F.T. Viana

{"title":"Serological analysis of COVID-19 patients highlights cross-reactivity of antibodies with the HIV-1 2F5 epitope","authors":"Tayná E. Lima , Carlos A.A. Brito , Laura H.V.G. Gil , Rafael Dhalia , Franciane M.E. Teixeira , Maria N. Sato , Gabriel L. Wallau , Roberto D. Lins , Isabelle F.T. Viana","doi":"10.1016/j.jcv.2025.105880","DOIUrl":"10.1016/j.jcv.2025.105880","url":null,"abstract":"<div><div>The Coronavirus disease 2019 (COVID-19) pandemic has raised concerns regarding the specificity of serological assays due to potential antibody cross-reactivity. In this study, we analyzed sera from 57 individuals infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using enzyme-linked immunosorbent assay (ELISA) to assess antibody recognition of a human immunodeficiency virus type 1 (HIV-1) envelope epitope (2F5). Cross-reactive binding to the HIV-1 antigen was detected in 38.5 % (22/57) of samples, indicating nonspecific antibody recognition. Interestingly, sera from HIV-1-infected individuals and the monoclonal anti-2F5 antibody exhibited no reactivity toward the SARS-CoV-2 Spike receptor-binding domain (RBD), indicating that cross-reactivity occurs in a unidirectional manner and does not compromise the specificity of RBD-based diagnostic assays. These findings support the specificity of RBD-targeted assays and advocate for careful interpretation of HIV-1 serological assays in individuals with recent SARS-CoV-2 infection, particularly where dual circulation occurs.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"Article 105880"},"PeriodicalIF":3.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145266770","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

In Memoriam 为纪念

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2025-12-01 Epub Date: 2025-10-03 DOI: 10.1016/j.jcv.2025.105878

Richard L. Hodinka

引用次数: 0

Assessing B19V epidemiology and viremia dynamics in plasma donors: A comprehensive analysis 评估血浆供者B19V流行病学和病毒动力学：一项综合分析。

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2025-12-01 Epub Date: 2025-09-22 DOI: 10.1016/j.jcv.2025.105873

Martin Wälti , Marco Natali , Adrian Sanden , Remo Leisi , Svenja Rohde , Rick Alexander , Jonas Sieber , Christoph Zürcher , Björn Keiner , Kelley Hyatt , Eva Quinley , Joyce Castaneda , Michael Schiffer , Denis Klochkov , Eleonora Widmer

{"title":"Assessing B19V epidemiology and viremia dynamics in plasma donors: A comprehensive analysis","authors":"Martin Wälti , Marco Natali , Adrian Sanden , Remo Leisi , Svenja Rohde , Rick Alexander , Jonas Sieber , Christoph Zürcher , Björn Keiner , Kelley Hyatt , Eva Quinley , Joyce Castaneda , Michael Schiffer , Denis Klochkov , Eleonora Widmer","doi":"10.1016/j.jcv.2025.105873","DOIUrl":"10.1016/j.jcv.2025.105873","url":null,"abstract":"<div><h3>Background</h3><div>Parvovirus B19 (B19V) infection is characterized by measurable bloodstream biomarkers, which vary over time indicating different phases of infection. High B19V DNA levels in the bloodstream are associated with infectivity, impacting the eligibility of source plasma donors.</div></div><div><h3>Objectives</h3><div>Characterize temporal changes in B19V epidemiological rates from January 2018 to April 2025 and to investigate the longitudinal dynamics of the diagnostic biomarkers and infectivity in subclinical infections among US source plasma donors.</div></div><div><h3>Results</h3><div>B19V positivity rates in CSL’s US source plasma donors decreased to a very low level during the COVID-19 pandemic and until Spring 2023 and re-emerged in two waves with peak rates ≥ 2.2-fold higher compared to pre-COVID data (2018 – 2020). During the exponential infection phase, B19V DNA doubled every 3–5 h, leading to high titers up to 10^12 IU/mL and peak infectivity of ∼10^8 TCID<sub>50</sub>/mL. Infectivity ceased when anti-B19V IgG reached a plateau or 14 days after DNA titer dropped below 4.8 × 10^5 IU/mL.</div></div><div><h3>Conclusions</h3><div>The re-emergence of B19V with high positivity rates highlights the relevance of donation testing for plasma. During the month from infection onset, B19V DNAemia correlates well with the measured infectious titer. B19V infectivity in plasma disappears within a month while DNA can persist in the plasma in absence of detectable infectivity, likely due to the immune response as characterized by the immunological markers.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"Article 105873"},"PeriodicalIF":3.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145292347","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

Assessing sample adequacy and clinical performance of self-collected and clinician-collected HPV specimens using internal control Ct values 使用内部控制Ct值评估自行采集和临床采集的HPV标本的样本充分性和临床表现

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2025-12-01 Epub Date: 2025-09-05 DOI: 10.1016/j.jcv.2025.105869

Marianna Martinelli , Sadaf Sakina Hassan , Emel Yilmaz , Camilla Lagheden , Sara Nordqvist Kleppe , Clementina Cocuzza , Laila Sara Arroyo Mühr

{"title":"Assessing sample adequacy and clinical performance of self-collected and clinician-collected HPV specimens using internal control Ct values","authors":"Marianna Martinelli , Sadaf Sakina Hassan , Emel Yilmaz , Camilla Lagheden , Sara Nordqvist Kleppe , Clementina Cocuzza , Laila Sara Arroyo Mühr","doi":"10.1016/j.jcv.2025.105869","DOIUrl":"10.1016/j.jcv.2025.105869","url":null,"abstract":"<div><h3>Background</h3><div>Human papillomavirus (HPV) testing is the primary method for cervical cancer screening, but reliable detection depends on adequate sample cellularity. Cycle threshold (Ct) values for the assay’s internal control (IC), such as β-globin, are commonly used as proxies for adequacy, yet standardized Ct cut-offs are lacking. We aimed to contribute evidence-based thresholds for sample adequacy using real-world data.</div></div><div><h3>Methods</h3><div>We analyzed 237,853 clinician-collected and self-collected samples tested with the BD Onclarity™ HPV Assay between 2022 and 2024. β-globin Ct values were assessed by HPV status to evaluate adequacy. Histologically confirmed CIN2+ outcomes were linked via the National Cervical Screening Registry to assess clinical performance.</div></div><div><h3>Results</h3><div>Among 110,482 clinician-taken samples, 73.63 % (81,350) were HPV negative; 74.32 % (60,457) of these had β-globin Ct ≤28, and only 1.28 % exceeded Ct 32.1. In 127,390 self-collected samples, 83.47 % (106,329) were HPV negative; 99.66 % (105,967) had Ct ≤28 and only 0.06 % exceeded Ct 32.1. HPV positivity declined gradually beyond Ct 26 and more markedly above Ct 28. CIN2+ cases (n = 5546) were rarely HPV negative (n = 73), and these showed low β-globin Ct values, indicating adequate cellularity. Self-collected samples had significantly lower Ct values than clinician-taken ones (median 21.5 vs. 26.5; p < 2.2e-16), likely due to lower resuspension volume.</div></div><div><h3>Conclusions</h3><div>Both clinician- and self-collected samples showed adequate cellularity, with potentially false negative HPV results from low cellular content appearing rare. Observed patterns suggest Ct <26 as optimal and Ct <28 as a minimum for program-level quality assurance with the BD Onclarity™ HPV Assay.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"Article 105869"},"PeriodicalIF":3.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145005151","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

Large spatial variation of intrahepatic HDV RNA levels without association with HBV core or S RNA levels in HDV cirrhosis patients 肝炎肝硬化患者肝内HDV RNA水平的大空间变异与HBV核心或S RNA水平无关

IF 3.4 3区医学

Journal of Clinical Virology Pub Date : 2025-12-01 Epub Date: 2025-09-12 DOI: 10.1016/j.jcv.2025.105871

Gustaf E. Rydell , Lucia Gonzales Strömberg , Johan Ringlander , Maria E. Andersson , Catarina Skoglund , Joakim Bedner Stenbäck , Staffan Nilsson , Maria Castedal , Magnus Lindh

{"title":"Large spatial variation of intrahepatic HDV RNA levels without association with HBV core or S RNA levels in HDV cirrhosis patients","authors":"Gustaf E. Rydell , Lucia Gonzales Strömberg , Johan Ringlander , Maria E. Andersson , Catarina Skoglund , Joakim Bedner Stenbäck , Staffan Nilsson , Maria Castedal , Magnus Lindh","doi":"10.1016/j.jcv.2025.105871","DOIUrl":"10.1016/j.jcv.2025.105871","url":null,"abstract":"<div><h3>Background</h3><div>The aim of this study was to investigate correlations between levels of intrahepatic HDV RNA, HBV RNA and corresponding serum markers in patients who underwent transplantation because of HDV-induced liver disease.</div></div><div><h3>Methods</h3><div>10 pieces of tissue from each of five liver explants from patients that underwent transplantation because of HDV-induced liver disease were analyzed by digital droplet PCR.</div></div><div><h3>Results</h3><div>A large variation of the tissue levels of viral RNA was found both between and within patients. Overall, tissue levels of HBV core and S RNA were positively associated. However, no consistent association was observed between tissue levels of HDV RNA and either core or S RNA, except in one patient. Furthermore, intrahepatic HDV RNA levels did not correlate with serum HDV RNA. Instead, serum HDV RNA showed a positive correlation with serum HBsAg, a trend towards correlation with tissue HBV S RNA and a significant correlation with core RNA levels.</div></div><div><h3>Conclusions</h3><div>The results suggest that intrahepatic HBsAg might be a limiting factor for HDV particle secretion, but do not support the hypothesis that HDV suppresses HBV replication.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"Article 105871"},"PeriodicalIF":3.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145109785","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