Journal of Clinical Virology最新文献

{"title":"Long-term stability of dried blood spot samples for HIV diagnosis in adults from Kinshasa (Democratic Republic of Congo)","authors":"Nerea Astiz ,&nbsp;Paula Martínez de Aguirre ,&nbsp;Silvia Carlos ,&nbsp;Samclide Mbikayi ,&nbsp;David Barquín ,&nbsp;Eduardo Burgueño ,&nbsp;África Holguín ,&nbsp;Gabriel Reina","doi":"10.1016/j.jcv.2025.105910","DOIUrl":"10.1016/j.jcv.2025.105910","url":null,"abstract":"<div><h3>Background</h3><div>Dried blood spots (DBS) are a widely used sampling method for serological testing, particularly in resource-limited settings. However, long-term stability of HIV antibodies in DBS remains underexplored. This study evaluates the stability of HIV serological markers stored at −80 °C for 7 years and compares the analytical performance and concordance of three different diagnostic techniques: electrochemiluminescence immunoassay (ECLIA), enzyme-linked fluorescent assay (ELFA), and immunochromatography.</div></div><div><h3>Methods</h3><div>Between 2016 and 2017, a total of 143 DBS samples were collected at Monkole Hospital in Kinshasa, D.R. Congo. For each patient, two DBS cards were prepared, each containing five spots of whole blood. The first card was analyzed in 2017 using three serological assays for HIV diagnosis: ECLIA (Roche), ELFA (bioMerieux), and immunochromatography (Geenius, BioRad). The second card was stored at −80 °C until 2024, when it was tested again using the same diagnostic tools.</div></div><div><h3>Results</h3><div>After 7 years of storage, HIV markers in DBS samples showed excellent stability. Sensitivity and specificity were 100 % for all techniques, except ECLIA, which produced one false positive. Inter-assay agreement was high in both 2017 and 2024, with Kappa values ranging from 0.90 to 1.00. Spearman correlation coefficients between 2017 and 2024 results were strong: 0.99 for ECLIA, 0.89 for ELFA, and 0.77–0.81 for immunochromatography. A significant increase in test values were observed for ELFA in 2024 but diagnostic classification remained unchanged.</div></div><div><h3>Conclusions</h3><div>High sensitivity, specificity, and inter-assay concordance support the long-term use of DBS for HIV diagnosis and surveillance. These findings can be particularly relevant for biobanking and retrospective seroepidemiology.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105910"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145880091","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}

{"title":"Head-to-head comparison of the performance of BIOFIRE® SPOTFIRE® Respiratory/Sore Throat Panel, Cepheid Xpert® Xpress SARS-CoV-2/Flu/RSV and Cobas® SARS-CoV-2 & Influenza A/B assay for detection of respiratory viruses","authors":"Dithi Banerjee,&nbsp;Anjana Sasidharan,&nbsp;Stephanie Gummersheimer,&nbsp;Sydnie Petty,&nbsp;Amanda O’Connor,&nbsp;Minati Dhar,&nbsp;Rangaraj Selvarangan","doi":"10.1016/j.jcv.2025.105902","DOIUrl":"10.1016/j.jcv.2025.105902","url":null,"abstract":"<div><h3>Background</h3><div>We compared the performance of 3 multiplex respiratory platforms - BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel (BioMérieux), Xpert® Xpress SARS-CoV-2/Flu/RSV assay (Cepheid) and Cobas® SARS-CoV-2 &amp; Influenza A/B assay (Roche) to detect Flu A/ B, SARS CoV-2 and RSV from nasopharyngeal swabs (NPS).</div></div><div><h3>Method</h3><div>A total of 250 leftover pediatric NPS from routine clinical testing (50 positives for each target and 50 negatives) were tested on all 3 platforms. Results were compared to a composite reference standard to calculate positive percent agreement (PPA) and negative percent agreement (NPA). For RSV, PPA and NPA were calculated by comparing Xpress and SPOTFIRE assays only. Discrepant samples were tested by single-plex PCRs for each viral target.</div></div><div><h3>Results</h3><div>PPA ranged between 97 % and 100 % for all targets except SARS-CoV-2 (86–97 %); NPA was &gt; 95 % by all assays. SPOTFIRE reported 35 (14 %) discrepant samples, Xpress and Liat reported 31 (12.4 %) and 14 (5.6 %) samples respectively. SPOTFIRE was positive for an additional respiratory virus (excluding Flu A/B, SARS-CoV-2 and RSV) in 110/250 (44 %) samples. All samples with initial invalid results on Xpress (5, 2 %), SPOTFIRE (3, 1.2 %) and Liat (2, 0.8 %) were valid on re-testing. Total hands-on time (specimen processing and loading, retrieving results) was less than 5 min for all assays.</div></div><div><h3>Conclusion</h3><div>All 3 assays showed 95 % agreement for Flu A and B detection; performance for SARS-CoV-2 detection varied. SPOTFIRE provides an advantage of detecting additional respiratory pathogens. Overall, the assays were easy to perform with minimum technical skill.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105902"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623054","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}

{"title":"External quality assessment for molecular detection of multiple respiratory pathogens in China","authors":"Xiaoyu Fan ,&nbsp;Chunli Shi ,&nbsp;Chengxiang Chu ,&nbsp;Zhongqiang Huang ,&nbsp;Yixiao Yang ,&nbsp;Yanqun Xiao ,&nbsp;Xiaobo Hu ,&nbsp;Xueliang Wang","doi":"10.1016/j.jcv.2025.105907","DOIUrl":"10.1016/j.jcv.2025.105907","url":null,"abstract":"<div><h3>Background</h3><div>Acute respiratory infections rank the fourth leading cause of mortality globally and impose a substantial burden on public health systems worldwide. Multiplex molecular assays have revolutionized the laboratory diagnosis of acute respiratory infections by enabling simultaneous detection of a broad range of respiratory pathogens. However, variations in nucleic acid extraction and amplification, signal interpretation, and result analysis may impact the consistency of results among laboratories. To systematically evaluate the performance among different laboratories and the comparability among different assays, the first round of an external quality assessment program for the molecular detection of multiple respiratory pathogens was implemented in China.</div></div><div><h3>Methods</h3><div>Each sample panel comprised nine single-infection and three co-infection samples containing various concentrations of inactivated pathogens. The sample panels were coded at random, and the returned results were scored.</div></div><div><h3>Results</h3><div>Among the 198 participating laboratories, 138 submitted valid datasets; 120 (86.9 %) of these were generated using commercial assays, whereas 18 (13.1 %) were based on laboratory-developed tests. Nine laboratories (6.5 %) achieved competent scores and 112 (81.2 %) exhibited acceptable scores; 17 laboratories (12.3 %) were deemed unqualified, requiring improvement. False results primarily arose from false-negative findings in samples with low pathogen concentrations. In addition, diagnostic performance varied across assays and even among pathogens within the same multiplex assay.</div></div><div><h3>Conclusions</h3><div>These findings indicate the need for further improvement in accurate detection of multiple respiratory pathogens and emphasized the value for continuous external quality assessment to improve the detection ability of laboratories.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105907"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145786756","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}

{"title":"2025 JCV reviewer recognition list and best reviewer awards.","authors":"","doi":"10.1016/j.jcv.2025.105888","DOIUrl":"https://doi.org/10.1016/j.jcv.2025.105888","url":null,"abstract":"","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"105888"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146063897","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}

{"title":"High levels of transmitted drug resistance to INSTIs and NNRTIs in Chile: A nationwide prevalence study","authors":"María Elena Ceballos ,&nbsp;Cinthya Ruiz-Tagle ,&nbsp;Angélica Domínguez de Landa ,&nbsp;Manuel A. Espinoza ,&nbsp;Marcela Ferrés ,&nbsp;María Elvira Balcells ,&nbsp;Alejandro Afani ,&nbsp;Felipe Castañeda ,&nbsp;Carlos Palma ,&nbsp;Carlos Gallo ,&nbsp;Olga López ,&nbsp;Yoselyn Castillo ,&nbsp;Francisco Salvador ,&nbsp;Elizabeth Barthel ,&nbsp;Francisco Zamora ,&nbsp;Martín Lasso ,&nbsp;Michel Serri ,&nbsp;Elisabeth Daube ,&nbsp;Nicolás Rodríguez ,&nbsp;Loreto Rojas","doi":"10.1016/j.jcv.2025.105890","DOIUrl":"10.1016/j.jcv.2025.105890","url":null,"abstract":"<div><h3>Background</h3><div>Human Immunodeficiency Virus (HIV) morbi-mortality and transmission have decreased due to antiretroviral therapy (ART). However, treatment failure still occurs when acquiring a strain with resistance mutations. HIV transmitted drug resistance (TDR) is increasing worldwide, and its prevalence in Chile was estimated at 10.4 % in 2018. We aimed to determine the prevalence of TDR and, its associated mutations to evaluate the need to incorporate genotyping studies in ART-naïve people living with HIV in Chile.</div></div><div><h3>Methods</h3><div>Cross-sectional study conducted in eleven health centers and seven regions in Chile. Participants were ≥ 18 years with a recent (≤12 months) HIV diagnosis, without previous ART exposure. Genotyping of the reverse transcriptase, protease, and integrase was performed using nested polymerase chain reaction followed by Sanger sequencing.</div></div><div><h3>Results</h3><div>Between February 2023 and May 2024, 168 participants were recruited. The mean age was 35.9 years (range 18–78), 89.3 % were Chilean, and 84.5 % were male. TDR overall prevalence was 16.7 %, and the percentage of TDR by family was 3 % for nucleoside reverse transcriptase inhibitors (NRTIs), 7.1 % for non-nucleoside reverse transcriptase inhibitors (NNRTIs), 0.6 % for protease inhibitors (PIs) and 8.9 % for integrase strand transfer inhibitors (INSTIs). TDR for first-generation INSTIs was 11.9 % and 1.2 % for second-generation INSTIs.</div></div><div><h3>Conclusion</h3><div>TDR prevalence in Chile has increased and main affected families are first-generation INSTIs and NNRTIs. This result highlights the relevance of initiating ART with second-generation INSTIs or PIs, or incorporating baseline genotyping studies when initiating ART with NNRTIs or first-generation INSTIs.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105890"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623056","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}

{"title":"Optimized respiratory virus influenza A whole genome sequencing strategies for improving even read coverage of segments","authors":"Ruimin Gao,&nbsp;Kennedy Irvine,&nbsp;Cody Buchanan,&nbsp;Cole Slater,&nbsp;Nikki PL Toledo,&nbsp;Jianjun Jia,&nbsp;Ameet Bharaj,&nbsp;Brittany Lagasse,&nbsp;April Powell,&nbsp;Nathalie Bastien","doi":"10.1016/j.jcv.2025.105904","DOIUrl":"10.1016/j.jcv.2025.105904","url":null,"abstract":"<div><div>Whole genome sequencing is increasingly being deployed to support respiratory virus influenza clinical studies and surveillance. However, PCR amplification inefficiency results in an imbalanced distribution among the eight segments, which makes it challenging to obtain complete genomes. The difficulties of amplifying the longer polymerase genes, particularly when the cycle threshold (Ct) of a specimen is greater than 25, were highlighted by the whole genome sequencing (WGS) data of 109 influenza A virus (IAV) specimens. We addressed the low genome coverage of the PB1 segment by incorporating additional singleplex PB1 primers into the WGS PCR assay, as well as balancing the ratio of forward primer variants targeting a single nucleotide polymorphism – either uracil (U) or cytosine (C) – located at the 4th position of the promoter region at the 3’ terminus. Furthermore, we have verified the improved performance of the Invitrogen™ UniPrime™ enzyme when compared to its predecessor, SuperScript IV™, and developed a more efficient thermal cycling condition (“C”) to generate eight complete IAV segments. Lastly, we determined that the optimal amplicon-to-bead volume ratio for removal of shorter, unwanted DNA fragments during PCR amplicon purification is 1:0.5. In summary, these optimizations improve the recovery of lower coverage segments and provide strategies aimed at obtaining high quality IAV genomes by means of Oxford Nanopore Technologies-based sequencing, ultimately providing valuable insights for better serving influenza clinical research and surveillance.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105904"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145682185","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}

{"title":"The diagnostic complexities of human herpesvirus 6 (HHV-6) infections","authors":"Katelyn L. Gough ,&nbsp;Taylah K. Anderson ,&nbsp;David M. Whiley ,&nbsp;Emma L. Sweeney","doi":"10.1016/j.jcv.2025.105905","DOIUrl":"10.1016/j.jcv.2025.105905","url":null,"abstract":"<div><div>Human herpesvirus 6 (HHV-6) is a common virus which is typically acquired early in childhood, and like other herpesviruses, can induce lifelong latency. While healthy individuals are not at risk of disease, immunosuppressed individuals such as those receiving hematopoetic stem cell transplantation are at substantial risk of morbidity and non-relapse mortality. Swift diagnosis and treatment remain crucial for the timely management of infections and reduce the severity of complications. A range of diagnostic approaches to detect HHV-6 have been established, the most common of which include PCR and serology; however, substantial challenges remain. Namely, existing diagnostic techniques struggle to differentiate between active HHV-6 infection, latency and chromosomal integration of HHV-6, which occurs in around 1 % of the population. Here, we discuss the established and emerging diagnostic tools for HHV-6, their strengths and limitations, and considerations for future diagnosis of this challenging viral pathogen.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105905"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145756931","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}

{"title":"Clinical evaluation of nasal swab specimens in VTM/UTM and RespDirect eSTM using the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay","authors":"Salika M. Shakir ,&nbsp;Robert K. McCall ,&nbsp;Rangaraj Selvarangan ,&nbsp;Dithi Banerjee ,&nbsp;Yitz Goldstein ,&nbsp;Christine Lansang ,&nbsp;Rachel Bogh ,&nbsp;Carmelle V. Remillard ,&nbsp;on behalf of the RespDirect Clinical Study Group","doi":"10.1016/j.jcv.2025.105908","DOIUrl":"10.1016/j.jcv.2025.105908","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory viral infections by SARS-CoV-2, influenza A and B viruses, and RSV overlap in disease signs and symptomology, but differ in treatment modality. Nasal swab specimens have been shown to be an effective alternative specimen type for SARS-CoV-2 detection.</div></div><div><h3>Objectives</h3><div>This study evaluated the performance of the Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay in anterior nasal swab specimens (self- or healthcare professional [HCP]-) collected in either viral/universal (VTM/UTM) transport media or the Hologic® RespDirect® collection kit (RespDirect swab in enhanced specimen transport media [eSTM]).</div></div><div><h3>Study design</h3><div>A multicenter study was conducted from October 2022 to March 2024. A total of 2686 nasal swab specimens collected in VTM/UTM or in eSTM were tested with the investigational assay and comparator molecular assays. Positive and negative agreement were calculated for each viral target.</div></div><div><h3>Results</h3><div>Overall, the results of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in nasal swab specimens demonstrated high concordance with the nasal swab-based molecular comparator methods with positive and negative percent agreement of 96.6 % and 98.9 % for SARS-CoV-2, 96.1 % and 99.3 % for influenza A virus, 96.0 % and 99.8 % for influenza B virus, and 97.7 % and 99.6 % for RSV, respectively. There were no statistically significant differences between specimens in VTM/UTM and eSTM and between self- or HCP-collected swabs in either transport medium for any of the viral pathogens.</div></div><div><h3>Conclusion</h3><div>The results of this study indicate that both self- and HCP- collected anterior nasal swabs in VTM or eSTM matrix are suitable options for detecting SARS-CoV-2, influenza A/B, and RSV using the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105908"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145786755","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}

{"title":"A series of diagnostic contamination events from seasonal influenza vaccines","authors":"Andreas Rohringer ,&nbsp;Marit H. Ebbesen ,&nbsp;Even Fossum ,&nbsp;Randi M. Nygaard ,&nbsp;Birgitte B. Madsen ,&nbsp;Margrethe Storm ,&nbsp;Nina Aasand ,&nbsp;Kjersti Rydland ,&nbsp;Karoline Bragstad ,&nbsp;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}

{"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 ,&nbsp;Marie-Noëlle Hilleret ,&nbsp;Dorra Guergour ,&nbsp;Carole Chirica ,&nbsp;Aurélie Truffot ,&nbsp;Patrice Morand ,&nbsp;Raphaële Germi ,&nbsp;Caroline Scholtès ,&nbsp;Sylvie Larrat ,&nbsp;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 log₁₀ 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}