Journal of Clinical Virology最新文献

{"title":"Human papillomavirus negative high grade cervical lesions and cancers: Suggested guidance for HPV testing quality assurance","authors":"Jean Luc Prétet ,&nbsp;Laila Sara Arroyo Mühr ,&nbsp;Kate Cuschieri ,&nbsp;María Dolores Fellner ,&nbsp;Rita Mariel Correa ,&nbsp;María Alejandra Picconi ,&nbsp;Suzanne M. Garland ,&nbsp;Gerald L. Murray ,&nbsp;Monica Molano ,&nbsp;Michael Peeters ,&nbsp;Steven Van Gucht ,&nbsp;Charlotte Lambrecht ,&nbsp;Davy Vanden Broeck ,&nbsp;Elizaveta Padalko ,&nbsp;Marc Arbyn ,&nbsp;Quentin Lepiller ,&nbsp;Alice Brunier ,&nbsp;Steffi Silling ,&nbsp;Kristiane Søreng ,&nbsp;Irene Kraus Christiansen ,&nbsp;Joakim Dillner","doi":"10.1016/j.jcv.2024.105657","DOIUrl":"10.1016/j.jcv.2024.105657","url":null,"abstract":"<div><h3>Background</h3><p>Some high-grade cervical lesions and cervical cancers (HSIL+) test negative for human papillomavirus (HPV). The HPV-negative fraction varies between 0.03 % and 15 % between different laboratories. Monitoring and extended re-analysis of HPV-negative HSIL+ could thus be helpful to monitor performance of HPV testing services. We aimed to a) provide a real-life example of a quality assurance (QA) program based on re-analysis of HPV-negative HSIL+ and b) develop international guidance for QA of HPV testing services based on standardized identification of apparently HPV-negative HSIL+ and extended re-analysis, either by the primary laboratory or by a national HPV reference laboratory (NRL).</p></div><div><h3>Methods</h3><p>There were 116 initially HPV-negative cervical specimens (31 histopathology specimens and 85 liquid-based cytology samples) sent to the Swedish HPV Reference Laboratory for re-testing. Based on the results, an international QA guidance was developed through an iterative consensus process.</p></div><div><h3>Result</h3><p>Standard PCR testing detected HPV in 55.2 % (64/116) of initially “HPV-negative” samples. Whole genome sequencing of PCR-negative samples identified HPV in an additional 7 samples (overall 61.2 % HPV positivity). Reasons for failure to detect HPV in an HSIL+ lesion are listed and guidance to identify cases for extended re-testing, including which information should be included when referring samples to an NRL are presented.</p></div><div><h3>Conclusion</h3><p>Monitoring the proportion of and reasons for failure to detect HPV in HSIL+ will help support high performance and quality improvement of HPV testing services. We encourage implementation of QA strategies based on re-analysis of “HPV negative” HSIL+ samples.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105657"},"PeriodicalIF":8.8,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000192/pdfft?md5=e9801bdb748e0efe4cc4bd6ddb25c7a4&pid=1-s2.0-S1386653224000192-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139924344","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 value and complexity of studying cellular immunity against BK Polyomavirus in kidney transplant recipients","authors":"Aurélien Aubry ,&nbsp;Baptiste Demey ,&nbsp;Sandrine Castelain ,&nbsp;François Helle ,&nbsp;Etienne Brochot","doi":"10.1016/j.jcv.2024.105656","DOIUrl":"10.1016/j.jcv.2024.105656","url":null,"abstract":"<div><p>BK Polyomavirus is of particular concern for kidney transplant recipients, due to their immunosuppression. This problem is exacerbated by the high effectiveness of antirejection therapies, which also compromise the organism's ability to fight viral infections. The long-term risk is loss of graft function through BKPyV-associated nephropathy (BKPyVAN). The assessment of host immunity and its link to the control of viral infections is a major challenge.</p><p>In terms of humoral immunity, researchers have highlighted the prognostic value of the pre-transplantation anti-BKPyV immunoglobulin G titer. However, humoral immunity alone does not guarantee viral clearance, and the correlation between the humoral response and the time course of the infection remains weak.</p><p>In contrast, cellular immunity variables appear to be more closely associated with viral clearance, given that the cellular immune response to the kidney transplant is the main target of immunosuppressive treatments in recipients. However, the assessment of the cellular immune response to BK Polyomavirus is complex, and many details still need to be characterized. Here, we review the current state of knowledge about BKPyV cellular immunity, as well as the difficulties that may be encountered in studying it in kidney transplant recipient. This is an essential area of research for optimizing the management of transplant recipients and minimizing the risks associated with insidious BKPyV disease.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105656"},"PeriodicalIF":8.8,"publicationDate":"2024-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000180/pdfft?md5=0873b08708568eea289d76a04a7428ab&pid=1-s2.0-S1386653224000180-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139924160","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":"Rapid antigen testing for SARS-CoV-2 by lateral flow assay: A field evaluation of self- and professional testing at UK community testing sites","authors":"Matthias E. Futschik ,&nbsp;Samuel Johnson ,&nbsp;Elena Turek ,&nbsp;David Chapman ,&nbsp;Simon Carr ,&nbsp;Zareen Thorlu-Bangura ,&nbsp;Paul E. Klapper ,&nbsp;Malur Sudhanva ,&nbsp;Andrew Dodgson ,&nbsp;Joanna R. Cole-Hamilton ,&nbsp;Nick Germanacos ,&nbsp;Raghavendran Kulasegaran-Shylini ,&nbsp;Edward Blandford ,&nbsp;Sarah Tunkel ,&nbsp;Timothy Peto ,&nbsp;Susan Hopkins ,&nbsp;Tom Fowler","doi":"10.1016/j.jcv.2024.105654","DOIUrl":"10.1016/j.jcv.2024.105654","url":null,"abstract":"<div><h3>Background</h3><p>The advent of lateral flow devices (LFDs) for SARS-CoV-2 detection enabled widespread use of rapid self-tests during the pandemic. While self-testing using LFDs is now common, whether self-testing provides comparable performance to professional testing was a key question that remained important for pandemic planning.</p></div><div><h3>Methods</h3><p>Three prospective multi-centre studies were conducted to compare the performance of self- and professional testing using LFDs. Participants tested themselves or were tested by trained (professional) testers at community testing sites in the UK. Corresponding qRT-PCR test results served as reference standard. The performance of Innova, Orient Gene and SureScreen LFDs by users (self) and professional testers was assessed in terms of sensitivity, specificity, and kit failure (void) rates. Impact of age, sex and symptom status was analysed using logistic regression modelling.</p></div><div><h3>Results</h3><p>16,617 participants provided paired tests, of which 15,418 were included in the analysis. Self-testing with Innova, Orient Gene or SureScreen LFDs achieved sensitivities of 50 %, 53 % or 72 %, respectively, compared to qRT-PCR. Self and professional LFD testing showed no statistically different sensitivity with respect to corresponding qRT-PCR testing. Specificity was consistently equal to or higher than 99 %. Sex and age had no or only marginal impact on LFD performance while sensitivity was significantly higher for symptomatic individuals. Sensitivity of LFDs increased strongly to up to 90 % with higher levels of viral RNA measured by qRT-PCR.</p></div><div><h3>Conclusions</h3><p>Our results support SARS-CoV-2 self-testing with LFDs, especially for the detection of individuals whose qRT-PCR tests showed high viral concentrations.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105654"},"PeriodicalIF":8.8,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000167/pdfft?md5=daa73e614638408a001b9967885ab74a&pid=1-s2.0-S1386653224000167-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139892936","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":"Quality control data management with unity real-time in molecular virology","authors":"Mikayla Quinton ,&nbsp;Duane W. Newton ,&nbsp;Becky Neil ,&nbsp;Sondra Mitchell ,&nbsp;Heba H. Mostafa","doi":"10.1016/j.jcv.2024.105655","DOIUrl":"https://doi.org/10.1016/j.jcv.2024.105655","url":null,"abstract":"<div><h3>Introduction</h3><p>Quality control (QC) is one component of an overarching quality management system (QMS) that aims at assuring laboratory quality and patient safety. QC data must be acceptable prior to reporting patients’ results. Traditionally, QC statistics, records, and corrective actions were tracked at the Johns Hopkins Molecular Virology Laboratory using Microsoft Excel. Unity Real-Time (UnityRT), a QMS software (Bio-Rad Laboratories), which captures and analyzes QC data by instrument and control lot per assay, was implemented and its impact on the workflow was evaluated. The clinical utility of real-time QC monitoring using UnityRT is highlighted with a case of subtle QC trending of HIV-1 quantitative control results.</p></div><div><h3>Methods</h3><p>A comprehensive workflow analysis was performed, with a focus on Epstein Barr Virus (EBV) and BKV quantitative viral load testing (Roche cobas 6800). The number of QC steps and time to complete each step were assessed before and after implementing UnityRT.</p></div><div><h3>Results</h3><p>Our assessment of monthly QC data review revealed a total of 10 steps over 57 min when using Microsoft Excel, versus 6 steps over 11 min when using UnityRT. HIV-1 QC monitoring revealed subtle trending of the low positive control above the mean from November to December 2022, correlating with a change in the reagent kit lot. This associated with a shift in patients’ results from positives below the lower limit of quantification to positives between 20 and 100 copies/mL.</p></div><div><h3>Conclusions</h3><p>UnityRT consolidated QC analyses, monitoring, and tracking corrective actions. UnityRT was associated with significant time savings, which along with the interfaced feature of the QC capture and data analysis, have improved the workflow and reduced the risk of laboratory errors. The HIV-1 case revealed the value of the real-time monitoring of QC.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105655"},"PeriodicalIF":8.8,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000179/pdfft?md5=9735fc96bfffc3d03b339cd08608d485&pid=1-s2.0-S1386653224000179-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139749129","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":"Differentiation of highly pathogenic strains of human JC polyomavirus in neurological patients by next generation sequencing","authors":"Eeva Auvinen ,&nbsp;Anni Honkimaa ,&nbsp;Pia Laine ,&nbsp;Sara Passerini ,&nbsp;Ugo Moens ,&nbsp;Valeria Pietropaolo ,&nbsp;Mika Saarela ,&nbsp;Leena Maunula ,&nbsp;Laura Mannonen ,&nbsp;Olli Tynninen ,&nbsp;Hannu Haapasalo ,&nbsp;Tuomas Rauramaa ,&nbsp;Petri Auvinen ,&nbsp;Hanna Liimatainen","doi":"10.1016/j.jcv.2024.105652","DOIUrl":"https://doi.org/10.1016/j.jcv.2024.105652","url":null,"abstract":"<div><h3>Background</h3><p>JC polyomavirus (JCPyV) persists asymptomatic in more than half of the human population. Immunocompromising conditions may cause reactivation and acquisition of neurotropic rearrangements in the viral genome, especially in the non-coding control region (NCCR). Such rearranged JCPyV strains are strongly associated with the development of progressive multifocal leukoencephalopathy (PML).</p></div><div><h3>Methods</h3><p>Using next-generation sequencing (NGS) and bioinformatics tools, the NCCR was characterized in cerebrospinal fluid (CSF; <em>N</em> = 21) and brain tissue (<em>N</em> = 16) samples from PML patients (<em>N</em> = 25), urine specimens from systemic lupus erythematosus patients (<em>N</em> = 2), brain tissue samples from control individuals (<em>N</em> = 2) and waste-water samples (<em>N</em> = 5). Quantitative PCR was run in parallel for diagnostic PML samples.</p></div><div><h3>Results</h3><p>Archetype NCCR (i.e. ABCDEF block structure) and archetype-like NCCR harboring minor mutations were detected in two CSF samples and in one CSF sample and in one tissue sample, respectively. Among samples from PML patients, rearranged NCCRs were found in 8 out of 21 CSF samples and in 14 out of 16 brain tissue samples. Complete or partial deletion of the C and D blocks was characteristic of most rearranged JCPyV strains. From ten CSF samples and one tissue sample NCCR could not be amplified.</p></div><div><h3>Conclusions</h3><p>Rearranged NCCRs are predominant in brain tissue and common in CSF from PML patients. Extremely sensitive detection and identification of neurotropic viral populations in CSF or brain tissue by NGS may contribute to early and accurate diagnosis, timely intervention and improved patient care.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105652"},"PeriodicalIF":8.8,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000143/pdfft?md5=4112f0302908005c9489e4d6d497a50c&pid=1-s2.0-S1386653224000143-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139737735","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":"Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar","authors":"Pedro Pisa ,&nbsp;Constance Wose Kinge ,&nbsp;Charles Chasela ,&nbsp;Eula Mothibi ,&nbsp;Yin Min Thaung ,&nbsp;Hnin T. Thwin ,&nbsp;Nay M. Aung ,&nbsp;Kara W. Chew ,&nbsp;Malini M. Gandhi ,&nbsp;Cavenaugh Clint ,&nbsp;Thomas Minior ,&nbsp;Aye A. Lwin ,&nbsp;Morgan J. Freiman ,&nbsp;Khin P. Kyi ,&nbsp;Yi Y. Sein ,&nbsp;Fadzai Marange ,&nbsp;Charles van der Horst ,&nbsp;Sofiane Mohamed ,&nbsp;Matthieu Barralon ,&nbsp;Ian Sanne","doi":"10.1016/j.jcv.2024.105653","DOIUrl":"10.1016/j.jcv.2024.105653","url":null,"abstract":"<div><h3>Background</h3><p>Developing countries experience limited access to HCV laboratory tests for different reasons. Providing near to real–time HCV testing and results especially to at–risk populations including those in rural settings for timely initiation to treatment is key. Within a rural Myanmar setting, we compared HCV diagnostic detection and quantification of the GeneXpert, and Advanced Biological Laboratories UltraGene–HCV assays against the gold standard and reference method Roche real–time HCV in Myanmar.</p></div><div><h3>Methods</h3><p>Blood samples from 158 high–risk individuals were assessed using three different methods at baseline. Results were checked for normality and log transformed. Log differences and bias between methods were calculated and correlated. Pearson's correlation coefficient was used to determine the association of HCV viral loads across all methods. The level of agreement with the standard method (Roche real time HCV) was assessed using Bland–Altman analyses.</p></div><div><h3>Results</h3><p>There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche having the strongest, <em>r</em> = 0.96, (<em>p</em>&lt;0.001). Compared to Roche, ABL (mean difference, 95 % limits of agreement; -0.063 and -1.4 to 1.3 Log10IU/mL) and GeneXpert (mean difference, 95 % limits of agreement; -0.28 and -0.7 to 1.8 Log10IU/mL) showed a good level of agreement with the GeneXpert being slightly superior.</p></div><div><h3>Conclusion</h3><p>We demonstrate the excellent performance and no-inferiority, in terms of levels of agreements of both GeneXpert and ABL compared to the Roche platform and supporting the use of the POC assays as alternative a cost-effective methods in HCV detection and diagnosis in developing and low resource settings countries.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105653"},"PeriodicalIF":8.8,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000155/pdfft?md5=09f425e484bdfe4e15922e598f5c3960&pid=1-s2.0-S1386653224000155-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139819700","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":"QuantiFERON–CMV assay by chemiluminescence immunoassay: Is it more suitable for real-live monitoring of transplant patients?","authors":"Raquel Fernández-Moreno ,&nbsp;Aurora Páez-Vega ,&nbsp;Diego Rodríguez-Cano ,&nbsp;Ana Salinas ,&nbsp;Fernando Rodríguez-Cantalejo ,&nbsp;Aurora Jurado ,&nbsp;Julián Torre-Cisneros ,&nbsp;Sara Cantisán","doi":"10.1016/j.jcv.2024.105651","DOIUrl":"https://doi.org/10.1016/j.jcv.2024.105651","url":null,"abstract":"<div><h3>Background</h3><p>The QuantiFERON<img>CMV (QF-CMV) assay is an interferon-gamma release assay (IGRA) used to monitor CMV-specific cell-mediated immunity (CMV-CMI) by ELISA in transplant patients. However, a chemiluminescent immunoassay (CLIA) has been developed to quantify IFNG in the QuantiFERON-Tuberculosis (TB) to detect latent TB infection.</p></div><div><h3>Objectives</h3><p>The aim of this work is to compare the results of QF-CMV by ELISA with those obtained by CLIA in an automated Liaison XL analyzer using the QuantiFERON-TB Gold Plus reagents.</p></div><div><h3>Study Design</h3><p>The QF-CMV assay had been performed by ELISA in kidney and lung transplant patients between July 2019-April 2023 at the IMIBIC/Reina Sofía Hospital (Cordoba, Spain). The remaining QF-CMV supernatants had been preserved at -80 ºC from then. Now, the IFNG levels in the same samples were determined by CLIA.</p></div><div><h3>Results</h3><p>One hundred and three QF-CMV supernatants from kidney (<em>n</em> = 50) and lung (<em>n</em> = 53) transplant patients were selected. An agreement of 87.4 % (kappa coefficient 0.788) between CLIA and ELISA was observed. Thirteen (12.6 %) discrepant results were detected. Some Indeterminate results by ELISA converted to Non-reactive by CLIA (0.53–0.92 IU/mL for Mitogen-Nil values). Likewise, borderline Non-reactive results by ELISA were above the 0.2 IU/mL cut-off by CLIA and then were Reactive (0.21–0.31 for CMV-Nil values).</p></div><div><h3>Conclusion</h3><p>CLIA shows substantial concordance with ELISA and acceptable discrepancies. The possible higher sensitivity of CLIA returns a higher number of Reactive results, which entails potential clinical consequences. Therefore, a new threshold to confer protection against CMV infection after transplantation needs to be defined.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105651"},"PeriodicalIF":8.8,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139718601","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":"Impact of anti-HDV reflex testing at HBs antigen positive discovery in a single center France: Support for primary HDV screening in France","authors":"Assilina Parfut ,&nbsp;Simona Tripon ,&nbsp;Pierre Gantner ,&nbsp;Fréderic Chaffraix ,&nbsp;Elodie Laugel ,&nbsp;Marie-Josée Wendling ,&nbsp;Furkan Erol ,&nbsp;Carine Wiedemer ,&nbsp;Michel Doffoel ,&nbsp;Antonio Saviano ,&nbsp;Maude Royant ,&nbsp;François Habersetzer ,&nbsp;Samira Fafi-Kremer ,&nbsp;Aurélie Velay","doi":"10.1016/j.jcv.2024.105650","DOIUrl":"10.1016/j.jcv.2024.105650","url":null,"abstract":"<div><h3>Background</h3><p>Hepatitis Delta virus (HDV) infection is a major cause of liver-related morbidity and mortality in patients infected with HBV, with a global HDV prevalence uncertain. In France, 2 to 5 % of HBs antigen (HBsAg) carriers present anti-HDV antibodies (anti-HDV). The EASL recommends testing for anti-HDV in all HBsAg-positive patients. Since January 2022, we have systematically carried out anti-HDV serology when a positive HBsAg is discovered (new HBsAg carriers).</p></div><div><h3>Objectives</h3><p>We evaluated the benefit of anti-HDV reflex testing after one year of practice by comparing anti-HDV and HBsAg serology data over the last six years, among the new HBsAg carriers and all the HBsAg carriers.</p></div><div><h3>Study design</h3><p>HBsAg and anti-HDV were screened using the Abbott Architect HBsAg quanti kit and the DIA.PRO HDVAb kit. Serological, demographic, virological, and clinical data were analyzed.</p></div><div><h3>Results</h3><p>Implementing anti-HDV reflex testing leads to more than a 2-fold increase in diagnoses of HDV infection among all HBsAg carriers. If the anti-HDV positive rate remains stable among the new HBsAg carriers, a significant increase in the anti-HDV positive rate from 6.8 % to 10.3 % was observed considering all HBsAg carriers. Interestingly, the discovery of anti-HDV carriage increased from 3.9 % to 6.5 % in 2022, allowing earlier identification of HBV-HDV-infected patients and a fast referral to hepatologists for adequate clinical management and, in some cases, the introduction of bulevirtide-based therapy.</p></div><div><h3>Conclusions</h3><p>Our preliminary results at one year seem promising and evaluating the cost-effectiveness of reflex tests in real life with feedback would be helpful.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105650"},"PeriodicalIF":8.8,"publicationDate":"2024-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139677435","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":"Validation of the clinical performance and reproducibility of the NeuMoDx HPV assay self-sample workflow","authors":"D.A.M. Heideman ,&nbsp;J. Berkhof ,&nbsp;L. Verhoef ,&nbsp;C. Ouwerkerk ,&nbsp;P.W Smit ,&nbsp;A. Oštrbenk Valenčak ,&nbsp;J. Mlakar ,&nbsp;M. Poljak ,&nbsp;R.D.M. Steenbergen ,&nbsp;M.C.G. Bleeker","doi":"10.1016/j.jcv.2024.105649","DOIUrl":"10.1016/j.jcv.2024.105649","url":null,"abstract":"<div><h3>Background</h3><p>Human papillomavirus (HPV) testing on self-samples is a valid tool for cervical cancer screening. HPV self-sample workflows need to be clinically validated to ensure safe use in screening.</p></div><div><h3>Objective</h3><p>This study evaluated the fully automated NeuMoDx HPV Assay self-sample workflow that is compiled of the NeuMoDx HPV assay and the NeuMoDx 96/288 Molecular Systems, for clinical performance and reproducibility on Evalyn Brush-collected self-samples.</p></div><div><h3>Methods</h3><p>The clinical performance of the NeuMoDx HPV Assay self-sample workflow for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3+ was evaluated on 987 self-samples obtained from women attending national organized HPV-based cervical cancer screening by a noninferiority analysis relative to reference workflows using either HPV-Risk Assay or high-risk HPV GP5+/6+-PCR. Intra- and inter-laboratory reproducibility of the NeuMoDx HPV Assay self-sample workflow using both NeuMoDx 96 and 288 Molecular Systems was assessed on 520 self-samples in three laboratories.</p></div><div><h3>Results</h3><p>The clinical sensitivity and specificity of the NeuMoDx HPV Assay self-sample workflow for the detection of CIN2+ and CIN3+ were found to be non-inferior to the reference workflows using either HPV-Risk Assay or high-risk HPV GP5+/6+-PCR, with all p-values &lt;0.034. The NeuMoDx HPV Assay self-sample workflow exhibited an intra-laboratory reproducibility of 94.4 % (95 %CI:92.5–96.1 %) with kappa value 0.86 (95 %CI:0.81–0.91). Inter-laboratory agreement was high (all ≥93.4 % and all kappa values ≥0.83).</p></div><div><h3>Conclusions</h3><p>The NeuMoDx HPV Assay self-sample workflow demonstrated high clinical accuracy for CIN2+/3+ and high reproducibility. The NeuMoDx HPV Assay self-sample workflow can be considered suitable for cervical cancer screening purposes.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105649"},"PeriodicalIF":8.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000118/pdfft?md5=9d80c7da473343ba9efee10cb9790b11&pid=1-s2.0-S1386653224000118-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139677365","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":"Don't rash it! The clinical significance of positive Varicella zoster virus PCR in cerebrospinal fluid of patients with neurological symptoms","authors":"Or Kriger ,&nbsp;Sarah Dovrat ,&nbsp;Ilana S. Fratty ,&nbsp;Eyal Leshem ,&nbsp;Michal Tepperberg Oikawa ,&nbsp;Danit Sofer ,&nbsp;Sharon Amit","doi":"10.1016/j.jcv.2024.105648","DOIUrl":"10.1016/j.jcv.2024.105648","url":null,"abstract":"<div><h3>Background</h3><p>Varicella zoster virus (VZV) is among the leading pathogens causing meningitis and encephalitis. While VZV-PCR-positive CSF is considered a gold-standard for diagnosis, it is not-uncommon to detect VZV-DNA in CSF of patients with other acute or chronic illness. Our goal was to determine the clinical relevance of VZV-PCR-positive CSF when investigating patients with neurological symptoms.</p></div><div><h3>Methods</h3><p>In this retrospective cohort from the largest hospital in Israel, we collected demographic, clinical and laboratory data of patients with VZV-PCR-positive CSF, analyzing the significance of various parameters.</p></div><div><h3>Results</h3><p>During a 5-years study, 125 patient-unique VZV-PCR-positive CSFs were recorded, in which only 9 alternative diagnoses were noted. The commonest symptoms were headache (<em>N</em> = 104, 83 %) and rash (<em>N</em> = 96, 76 %). PCR-cycle-threshold (Ct), a surrogate of viral burden, did not significantly vary across the clinical manifestations; however, patients with rash and Ct&lt;35 were prone to develop stroke in the following year (<em>N</em> = 6, 7 %). Empiric nucleoside-analogue treatment was not associated with a better outcome compared to treatment administered upon a positive-PCR result.</p></div><div><h3>Discussion</h3><p>Our findings suggest that in patients with neurological symptoms, detection of VZV-DNA in CSF renders VZV the probable culprit. Nevertheless, a systematic evaluation of treatment and follow-up algorithms of patients with suspected or proved VZV meningitis and encephalitis is needed. The benefits of a prompt treatment should be weighed against the potential complications of nucleoside-analogue. Conversely, the propensity for stroke in patients with higher viral-burden, necessitates further studies assessing VZV causal role, directing additional workup, treatment and monitoring policy.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105648"},"PeriodicalIF":8.8,"publicationDate":"2024-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139555857","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}