Journal of Clinical Virology最新文献

{"title":"Serological analysis of COVID-19 patients highlights cross-reactivity of antibodies with the HIV-1 2F5 epitope","authors":"Tayná E. Lima ,&nbsp;Carlos A.A. Brito ,&nbsp;Laura H.V.G. Gil ,&nbsp;Rafael Dhalia ,&nbsp;Franciane M.E. Teixeira ,&nbsp;Maria N. Sato ,&nbsp;Gabriel L. Wallau ,&nbsp;Roberto D. Lins ,&nbsp;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":"2025-10-10","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}

{"title":"Utility of cytomegalovirus (CMV) qualitative polymerase chain reaction from gastrointestinal biopsies in diagnosis of CMV gastrointestinal disease: A 10-year retrospective study.","authors":"Cole Schonhofer, Calvin Ka-Fung Lo, Daniel R Owen, Khuloud Aldhaheri, Nancy Matic, Christopher F Lowe, David F Schaeffer, Sara Belga, Alissa Wright","doi":"10.1016/j.jcv.2025.105879","DOIUrl":"https://doi.org/10.1016/j.jcv.2025.105879","url":null,"abstract":"<p><strong>Background: </strong>Cytomegalovirus (CMV) gastrointestinal (GI) disease is traditionally diagnosed via histopathology of endoscopic tissue biopsies. The utility of tissue PCR for predicting CMV GI disease remains unclear. We conducted a 10-year retrospective single-center study comparing tissue PCR performance to histopathology for the diagnosis of CMV GI disease.</p><p><strong>Methods: </strong>Adult patients with GI tissue biopsy between February 2014 and January 2024 were included. Qualitative tissue PCR was compared to histopathology (gold standard) to determine sensitivity, specificity, and receiver operating characteristic (ROC) curves. Log-binomial regression models were performed to evaluate potential predictors of CMV GI disease.</p><p><strong>Results: </strong>Our study comprised 533 patients with 635 endoscopies. Underlying diagnoses included solid organ transplant, hematopoietic stem cell transplantation (HSCT), inflammatory bowel disease, and others. Histopathologic evidence of CMV disease was found in 41/635 biopsies and in 37/533 patients. Compared to histopathology, tissue PCR sensitivity was 100 % (95 % CI 91.4-100 %), and specificity was 71.7 % (67.9-75.3 %). Area under ROC curve (AUC) was 0.86 (0.84-0.88). Exclusion of specimens with cycle threshold >32 increased specificity to 82.7 % (79.4-85.6 %) but at the cost of decreased sensitivity (87.8 %, 73.8-95.9 %). Multivariable analyses demonstrated that plasma CMV DNAemia >1000 IU/mL increased risk of GI disease (risk ratio 10.9, 95 % CI 5.32-22.49) while HSCT was negatively associated (risk ratio 0.18, 95 % 0.05-0.78).</p><p><strong>Conclusion: </strong>CMV tissue PCR correctly identified CMV GI disease in 100 % of histology-proven cases. Specificity was poor, likely reflecting detection of viral shedding. Overall, our study suggests that CMV tissue PCR should be reserved to rule out CMV GI disease in high pre-test probability settings (e.g. patients with known risk factors and compatible symptoms).</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"105879"},"PeriodicalIF":3.4,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145292350","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":"Some assembly required: Comparison of bioinformatic pipelines for analysis of viral metagenomic sequencing from nosocomial respiratory virus outbreaks","authors":"Assad Alhaboub ,&nbsp;Natalie M. Deschenes ,&nbsp;Xena X. Li ,&nbsp;Victoria R. Williams ,&nbsp;Kevin C. Katz ,&nbsp;So Yeon Park ,&nbsp;Patryk Aftanas ,&nbsp;Henry Wong ,&nbsp;Calvin Sjaarda ,&nbsp;Kyla Tozer ,&nbsp;Finlay Maguire ,&nbsp;Jerome Leis ,&nbsp;Prameet Sheth ,&nbsp;Robert Kozak","doi":"10.1016/j.jcv.2025.105877","DOIUrl":"10.1016/j.jcv.2025.105877","url":null,"abstract":"<div><h3>Introduction</h3><div>Metagenomic sequencing (mGS) is a useful tool for identifying pathogens in patient samples. During nosocomial outbreaks of respiratory viruses, mGS allows for the identification of viral strains and provides insight into their genetic relatedness. Multiple bioinformatics analysis assembler are available for processing data, but a comprehensive comparison of their performance in for respiratory virus outbreaks has not been conducted.</div></div><div><h3>Methods</h3><div>This study sequenced samples from five separate nosocomial outbreaks of RNA respiratory viruses. RNA was extracted from the samples, and cDNA was synthesized using random hexamers, and then sequenced on an Illumina Miniseq following Nextera DNA Flex library preparation. The data from each outbreak were analyzed using four different assemblers: MEGAHIT, rnaSPAdes, rnaviralSPAdes, and coronaSPAdes, to evaluate their analytical performance.</div></div><div><h3>Results</h3><div>The mGS confirmed the viral identification and provided accurate strain identification for both coronavirus and parainfluenza virus samples. However, differences were observed between the assemblers in terms of the largest contigs produced and the proportion of the viral genome aligned with reference genomes. Notably, coronaSpades outperformed the other pipelines for analyzing seasonal coronaviruses, generating more complete data and covering a higher percentage of the viral genome.</div></div><div><h3>Conclusion</h3><div>Achieving a higher percentage of the viral genome sequence is crucial for a more detailed characterization, which is especially valuable for outbreak analysis where viral strains may only differ by a few genetic changes. Comparison of assemblers will allow for clinical laboratories to determine the bioinformatic pipeline that is optimal for helping clinicians better manage outbreaks.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"Article 105877"},"PeriodicalIF":3.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220249","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":"Pathogen surveillance of acute conjunctivitis reveals recent emergence of coxsackievirus A24 variants and high genotypic diversity of human adenoviruses in Shenzhen, China, 2018-2024.","authors":"Long Chen, Hong Yang, Hai-Long Zhang, Xiao-Lu Shi, Bo Peng, Jun Meng","doi":"10.1016/j.jcv.2025.105852","DOIUrl":"10.1016/j.jcv.2025.105852","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the etiological characteristics of acute conjunctivitis in Shenzhen, China.</p><p><strong>Methods: </strong>A total of 1234 conjunctival swabs collected between 2018 and 2024 were examined for coxsackievirus A24 variant (CVA24v), enterovirus D70 (EV-D70) and human adenovirus (HAdV). Complete VP1 sequences of CVA24v strains were determined and analyzed. HAdV was genotyped by PCR methods targeting the three genes (penton base, hexon and fiber) and sequencing. SPSS 22.0 software was used for statistical analysis.</p><p><strong>Results: </strong>CVA24v was first detected in 2023, with a detection rate of 33.3 % (63/189). No EV-D70 was detected in 2018-2024. The annual distributions of HAdV-infected patients were 52.6 % (101/192), 62.7 % (111/177), 21.1 % (37/175), 9.0 % (14/155), 10.5 % (17/162), 15.9 % (30/189) and 21.7 % (40/184), respectively. CVA24v strains from this study clustered in a clade with significant temporal aggregation characteristic within the genotype GIV. Eight amino acid variation sites (T11A, I16L, K20I, L32P, K105R, A146T, R277G and P280S) were observed in VP1 sequences of CVA24v strains from this study when compared to the close strains. Conjunctivitis patients with one of the three symptoms (weakness, fever and blurred vision) had a higher detection rate of HAdV. Eleven known HAdV genotypes (HAdV-B3, -B14, -B21, HAdV-D8, -D37, -D42, -D53, -D64, -D85, -D115 and HAdV-E4) and 7 unknown genotypes were detected in 2020-2024, with HAdV-D37 (30.9 %), HAdV-D115 (21.1 %) and HAdV-B3 (17.1 %) being the three predominant genotypes.</p><p><strong>Conclusions: </strong>The unique genetic characteristics were observed in Shenzhen CVA24v strains. HAdVs associated with conjunctivitis exhibited a high degree of genotypic diversity in Shenzhen, and HAdV-D115 related to conjunctivitis was first reported in this study.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105852"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144812096","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":"Identifying people with chronic hepatitis B virus who are lost to clinical follow up: A retrospective case finding and re-engagement service improvement exercise","authors":"Rachel Jackson ,&nbsp;Adinah Marks ,&nbsp;William L. Irving ,&nbsp;Kathryn Jack","doi":"10.1016/j.jcv.2025.105876","DOIUrl":"10.1016/j.jcv.2025.105876","url":null,"abstract":"<div><h3>Background</h3><div>Hepatitis B virus (HBV) infection is an important cause of liver disease-related mortality and morbidity. The World Health Organisation aims to eliminate this as a public health concern by 2030 and as such the key international guidelines recommend that all patients are reviewed regularly to observe for preventable signs of disease progression. This requires life-long engagement with specialist services, but some patients fall out of the care pathway and become lost to follow-up.</div></div><div><h3>Objectives</h3><div>This study sought to identify and re-engage patients with HBV who were lost to follow up (LTFU), defined as any HBsAg positive patient who had not been seen in the hepatology outpatient service since 31st December 2021, excluding those with acute infection.</div></div><div><h3>Study design</h3><div>A retrospective case finding and re-engagement healthcare service improvement exercise was conducted to identify and contact individuals with HBV diagnosed between June 2007 and the end of December 2021 who were lost-to-follow-up.</div></div><div><h3>Results</h3><div>One third of the HBsAg positive cohort were lost to follow-up (32.9 %, n = 506/1539). Of this group, 145 people were still living in the hospital’s catchment area, yet only 60 people could be contacted by telephone of whom 50 returned to clinic. More than 12 % of patients were HBeAg positive at their last clinic visit, and almost one quarter (23.2 %) had an abnormally raised ALT. There was extensive ethnic heterogeneity with 65 languages spoken among 474 people. We successfully re-engaged 10.07 % (51/506) back into care.</div></div><div><h3>Conclusions</h3><div>Patients with potentially progressive HBV-related liver disease are falling out of the care pathway with the attendant long-term problems that failure to control their infection may have.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"Article 105876"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220248","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":"More aggressive initiation of antiviral treatment contributes to blocking mother-to-child transmission of HBV DNA & RNA in neonatal umbilical cord blood","authors":"Huimin Liu ,&nbsp;Wenting Chen ,&nbsp;Yongjie Liang ,&nbsp;Jing Wang ,&nbsp;Lijian Ran ,&nbsp;Shilian Li ,&nbsp;Yi Wu ,&nbsp;Zixuan He ,&nbsp;Xuemei Kuang ,&nbsp;Jie Xia ,&nbsp;Li Jiang ,&nbsp;Xuqing Zhang ,&nbsp;Qing Mao","doi":"10.1016/j.jcv.2025.105875","DOIUrl":"10.1016/j.jcv.2025.105875","url":null,"abstract":"<div><h3>Background and aims</h3><div>This study aimed to evaluate the efficacy of expanding antiviral indications in preventing mother-to-child transmission (MTCT) by analyzing hepatitis B virus (HBV) markers in neonatal umbilical-cord-blood (UCB) samples.</div></div><div><h3>Methods</h3><div>We conducted a real-world study of pregnant women aged &gt;30 years with chronic hepatitis B (CHB) who received antenatal care between January 2022 and June 2024. Maternal HBV markers at 24–28 weeks of gestation and serum biochemical parameters at delivery were obtained. For infants, HBV markers were measured in UCB at birth and in venous blood at 7–12 months of age. Logistic regression analysis was used to identify the maternal factors associated with UCB outcomes.</div></div><div><h3>Results</h3><div>A total of 171 pregnant women with CHB were included. Antiviral therapy had been started before conception in 31.0 % (53/171). At 24–28 weeks of gestation, 87.8 % (150/171) had HBV DNA &lt;5.3 Log₁₀ IU/mL, 56.1 % (96/171) had hepatitis B surface antigen (HBsAg) &gt;3000 IU/mL and 32.7 % (56/171) were hepatitis B e antigen (HBeAg)-positive. At delivery, HBeAg-negative mothers had a median age of 33.4 ± 3.1 years, compared with 32.5 ± 2.9 years for those who were HBeAg-positive, respectively (t = 1.667, <em>P</em> = 0.970). 36 of 171 (21.1 %) infants were positive for HBsAg, including 12 of 115 born to HBeAg-negative mothers and 24 of 56 born to HBeAg-positive mothers (χ² = 23.82, <em>P</em> &lt; 0.001). 41 of 171 (24.0 %) infants were positive for HBeAg, and all were born to HBeAg-positive mothers. HBV DNA and RNA were undetectable in all UCB samples, whereas hepatitis B core antibody (HBcAb) was present in every specimen. Receiver operating characteristic curve (ROC) analysis identified maternal HBeAg levels (AUC=0.683, cut-off value=0.494 COI) and maternal HBV DNA load (AUC=0.645, cut-off value=0.311 Log₁₀ IU/mL) as predictive of UCB HBsAg-positivity. No infants were infected with HBV, as confirmed by post-vaccination serologic testing (PVST).</div></div><div><h3>Conclusions</h3><div>Following the expansion of antiviral therapy indications, administering therapy to pregnant women aged &gt;30 years with detectable HBV DNA effectively reduced HBsAg, HBV DNA and even HBV RNA level in infants’ UCB. Maternal HBeAg status was significantly associated with both HBsAg and HBeAg positivity in UCB.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"181 ","pages":"Article 105875"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145268018","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":"Heterogeneity of false reactivity profiles of HIV assays while optimizing national HIV testing algorithms: Findings from a multi-country analysis.","authors":"Manfred Accrombessi, Cheryl Johnson, Alaleh Abadpour, Jean De Dieu Anoubissi, Joseph Fokam, Araz Chiloyan, Iryna Andrianova, Hamakwa Mantina, Agai Kherbino Akec, Fatou Ousmane Sall, Abdelaye Keita, Elizabeth Telan, Adoum Fouda Abderrazzack, Chatté Adawaye, Rose Wafula, Stephen Ayisi-Addo, Monkoe S Leqheka, Jacob Lusekelo Mwambeta, Jeremie Muwonga Masidi, Dramane Kania, Anita Sands, Rachel Baggaley, Jean-François Etard, Céline Lastrucci","doi":"10.1016/j.jcv.2025.105843","DOIUrl":"10.1016/j.jcv.2025.105843","url":null,"abstract":"<p><p>This study highlights the importance of verifying HIV testing algorithms to reduce the risk of misdiagnoses caused by common false reactivity. Between 2020 and 2023, WHO supported 14 countries to assess rates of false reactivity and shared false reactivity across HIV rapid diagnostic tests (RDTs) used in HIV testing services. The study involved 26,278 results from 22 different RDT products, with sample sizes ranging from 100 to 302 results per country. The number of RDT products assessed varied between 4 and 13 per country. False reactivity rates ranged from 0 % to 3.32 %, with one country reporting a high false reactivity rate of over 4 % for one RDT. Five countries have no shared false reactivity between RDTs, while the remaining eight countries shared false reactivity across one to six pairs of RDT products. These findings were used to inform national policy, with more than 90 % of countries introducing new RDT products into their HIV testing algorithm based on these results. The study concludes that rates of false reactivity and shared false reactivity between RDT products vary across countries. Therefore, conducting verification studies is crucial for updating national HIV testing algorithms and ensuring accurate diagnosis while also facilitating the market entry of new HIV testing products.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105843"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12439682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Allplex HPV HR Detection assay fulfils international guideline requirements for primary cervical screening on SurePath samples and qualifies as a second-generation HPV comparator test.","authors":"Anja Oštrbenk, Helle Pedersen, Mario Poljak, Jesper Bonde","doi":"10.1016/j.jcv.2025.105853","DOIUrl":"10.1016/j.jcv.2025.105853","url":null,"abstract":"<p><p>A key parameter for the continued success of cervical cancer screening is quality-controlled use of human papillomavirus (HPV) tests that are clinically validated according to international guidelines. The clinical accuracy for cervical screening of the Allplex HPV HR Detection (Allplex), which concurrently detects and distinguishes 12 high-risk HPV types (16,18,31,33,35,39,45,51,52,56,58,59) and HPV66 and HPV68 was assessed on SurePath samples by comparing its performance to the second-generation comparator BD Onclarity HPV assay (Onclarity). The absolute clinical sensitivity, assessed on 76 samples derived from a screening population with underlying CIN2+, of Allplex and Onclarity was 98.7 % (95 % CI, 92.9-100.0 %) and 100.0 % (95 % CI, 95.2-100.0 %), respectively, with relative sensitivity of Allplex of 0.99 (95 % CI; 0.96-1.01). The absolute clinical specificity, assessed on 801 consecutive clinician-collected cervical samples obtained from women 30 to 59 years old attending the routine Danish cervical screening program, for Allplex and Onclarity was 92.5 % (95 % CI, 90.4-94.2 %) and 92.5 % (95 % CI, 90.4-94.2 %), respectively, with relative specificity of Allplex of 1.00 (95 % CI; 0.99-1.01). With thresholds mandated by international guidelines of ≥90 % for relative clinical sensitivity (p = 0.001) and ≥98 % for relative clinical specificity (p = 0.0018), Allplex was non-inferior to Onclarity. Excellent intra- and inter-laboratory agreement of Allplex was observed, both overall (99.2 % and 99.6 %) and at the genotype level (range: 99.6-100.0 %). By fulfilling all guideline requirements for clinical sensitivity, specificity, and reproducibility, Allplex can be considered clinically validated for primary cervical screening using clinician-collected SurePath samples. With this study, Allplex also meets the criteria for a second-generation HPV comparator test.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105853"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144804233","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":"Performance of a commercial assay for detecting JC Polyomavirus DNA in human samples.","authors":"Sébastien Lhomme, Isabelle Da Silva, Oriane Cabanel, Estelle Raguin, Guillaume Martin-Blondel, Nassim Kamar, Jacques Izopet, Florence Abravanel","doi":"10.1016/j.jcv.2025.105849","DOIUrl":"10.1016/j.jcv.2025.105849","url":null,"abstract":"<p><strong>Introduction: </strong>We evaluated the performance of the automated AltoStar JCV PCR platform for detecting and quantifying JC Polyomavirus (JCPyV) DNA in samples including urine, plasma and cerebrospinal fluid.</p><p><strong>Methods and results: </strong>Using the NIBSC JCPyV DNA standard, the assay was linear from 1 to 6 log IU/mL standard and the limit of detection determined by Probit analysis corresponded to 9.3 [95 % CI: 7.0-16.5] IU/mL. Specificity was accessed by testing urines containing a high concentration of BK Polyomavirus; none tested positive for JCPyV. The intra-run and inter-run standard deviations were 0.02 IU/mL and 0.35 IU/mL, respectively. Lastly, clinical performance was determined by testing 45 samples quantified previously with a laboratory-developed test (LDT). The assays were concordant for 42/45 samples. One of the 3 samples that tested negative with the AltoStar assay had a low JCpyV DNA concentration. We were unable to re-test the 3 negative samples due to insufficient volume. A conservation problem could not be ruled out for the 3 samples with discordant results.</p><p><strong>Conclusions: </strong>The AltoStar platform enables highly accurate testing for the detection and quantification of JCPyV DNA with very low limit of detection. This allowed us to shorten turnaround times and save time for technical staff.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105849"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144804232","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":"Comparison of diagnostic performances of HDV-RNA quantification assays used in clinical practice: Results from a national quality control multicenter study.","authors":"Romina Salpini, Lorenzo Piermatteo, Gian Paolo Caviglia, Ada Bertoli, Maurizia Rossana Brunetto, Bianca Bruzzone, Annapaola Callegaro, Cinzia Caudai, Daniela Cavallone, Luchino Chessa, Fernando Coghe, Nicola Coppola, Nunzia Cuomo, Stefano D'Anna, Mariantonietta Di Stefano, Floriana Facchetti, Claudio Farina, Donatella Ferraro, Elisa Franchin, Daniela Francisci, Silvia Galli, Anna Rosa Garbuglia, William Gennari, Valeria Ghisetti, Pietro Lampertico, Sergio Lo Caputo, Nadia Marascio, Stefano Menzo, Valeria Micheli, Grazia Anna Niro, Antonella Olivero, Pierpaolo Paba, Concetta Ilenia Palermo, Orazio Palmieri, Stefania Paolucci, Mariantonietta Pisaturo, Teresa Pollicino, Giuseppina Raffa, Teresa Santantonio, Giulia Torre, Ombretta Turriziani, Sergio Uzzau, Sara Colonia Uceda Renteria, Marialinda Vatteroni, Maurizio Zazzi, Antonio Craxì, Francesca Ceccherini-Silberstein, Valentina Svicher, Marco Arosio, Sabrina Bastianelli, Annamaria Gentile, Federica A M Giardina, Anna Gidari, Rosalba Govoni, Gabriele Ibba, Alessandro Loglio, Alessandra Lombardi, Chiara Mascarella, Fabrizio Maggi, Giovanni Matera, Chiara Mazzei, Maria Grazia Milia, Angela Quirino, Adriana Raddi, Rosetta Scioscia, Sara Tagliazucchi, Michele Totaro, Rea Valaperta","doi":"10.1016/j.jcv.2025.105850","DOIUrl":"10.1016/j.jcv.2025.105850","url":null,"abstract":"<p><strong>Introduction: </strong>A reliable quantification of hepatitis D virus (HDV) RNA is of paramount importance for monitoring patients under antiviral therapy. This quality control study compares the diagnostic performances of quantitative HDV-RNA assays used in clinical practice.</p><p><strong>Methods: </strong>Two HDV-RNA sample panels were quantified in 30 centers by RoboGene (N = 9 laboratories), EurobioPlex (N = 7), RealStar (N = 4), AltoStar (N = 1), Bosphore (N = 3), Bosphore-on-InGenius (N = 1), Dia.Pro (N = 2), Nuclear-Laser-Medicine (N = 1) and 3 in-house assays. Panel A and B comprised 8 serial dilutions of WHO/HDV standard (range: 0.5-5.0 log10 IU/ml) and 20 clinical samples (range: 0.5-6.0 log10 IU/ml), respectively. The following parameters were determined: sensitivity by 95 % LOD (limit of detection), precision by intra- and inter-run CV (coefficient of variation), accuracy by the differences between expected-observed HDV-RNA, linearity by linear regression analysis.</p><p><strong>Results: </strong>95 % LOD varied across assays and centers underlining heterogeneous sensitivities: AltoStar had the lowest 95 % LOD (3 IU/ml) followed by RealStar (10 [min-max: 3-316] IU/ml), Bosphore-on-InGenius (10 IU/ml), RoboGene (31 [3-316] IU/ml), Nuclear-Laser-Medicine (31 IU/ml) and EuroBioplex (100 [100-316] IU/ml). Moreover, 6 assays (RoboGene, EurobioPlex, RealStar, AltoStar, Nuclear-Laser-Medicine and In-house) showed <0.5 log10 IU/ml differences between expected and observed HDV-RNA for all dilutions while other assays had >1 log10 IU/ml underestimations. RealStar, Bosphore-on-InGenius and EurobioPlex had the highest precision (mean intra-run CV < 20 %). Inter-run CV was higher for all assays, with CVs < 25 % for RealStar, AltoStar, Nuclear-Laser-Medicine and EurobioPlex. Seven assays (RoboGene/AltoStar/RealStar/EurobioPlex/Nuclear-Laser-Medicine/In-house) showed a good linearity (R² > 0.90), but for HDV-RNA < 1000 IU/ml only Bosphore-on-InGenius, AltoStar, RealStar and Robogene showed a R² > 0.85.</p><p><strong>Conclusions: </strong>This study underlines heterogeneous sensitivities (inter- and intraassays), that could hamper proper HDV-RNA quantification, particularly at low viral loads. This raises the need to improve the diagnostic performance of most assays for properly identifying virological response to anti-HDV drugs.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105850"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816830","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}