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2023 global inventory of commercial molecular tests for human papillomaviruses (HPV) J. Clin. Virol. (IF 8.8) Pub Date : 2024-03-14 Mario Poljak, Anja Oštrbenk Valenčak, Kate Cuschieri, Klara B. Bohinc, Marc Arbyn
To suit the needs of the human papillomaviruses (HPV) community comprehensively, a range of commercial HPV tests with different performance characteristics are required. Four periodic inventories of commercial HPV molecular tests present in the global market were published previously in 2010, 2012, 2015 and 2020. For the fifth inventory, data were retrieved from internal files and a detailed search
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Enterovirus and parechovirus meningoencephalitis in infants: a ten-year prospective observational study in a neonatal intensive care unit J. Clin. Virol. (IF 8.8) Pub Date : 2024-03-05 Carlo Pietrasanta, Andrea Ronchi, Laura Bassi, Agnese De Carli, Luca Caschera, Francesco Maria Lo Russo, Beatrice Letizia Crippa, Silvia Pisoni, Riccardo Crimi, Giacomo Artieri, Laura Pellegrinelli, Robertino Dilena, Giorgio Conte, Fabio Mosca, Monica Fumagalli, Lorenza Pugni
Non-polio enteroviruses (EV) and human parechoviruses (HPeV) are known etiological agents of meningoencephalitis in neonates. However, reports of neuroradiological findings and neurodevelopmental outcomes in this population are scarce. to describe clinical characteristics, neuroradiological findings and, in a subset of patients, neurodevelopmental outcomes in a cohort of infants with EV or HPeV meningoencephalitis
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Evaluation of the ELITechGroup solution for plasma HIV-1 RNA quantification J. Clin. Virol. (IF 8.8) Pub Date : 2024-03-03 Adeline Baron, Alice Moisan, Guillemette Unal, Véronique Lemée, Manuel Etienne, Jean-Christophe Plantier
In the last few years, many manufacturers have developed new kits for plasma HIV-1 RNA quantification. Recently, a solution consisting of the ELITe InGenius® instrument and the HIV1 ELITe MGB®kit has been commercialized worldwide. Our aim was to compare its clinical performance with the Aptima® HIV-1 Quant Dx kit by Hologic, on a panel of HIV-1 group M circulating variants, representative of viral
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Human monkeypox virus: Epidemiologic review and research progress in diagnosis and treatment J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-28 Yanhong Sun, Wenjian Nie, Dandan Tian, Qing Ye
Monkeypox virus (MPXV) is responsible for causing a zoonotic disease called monkeypox (mpox), which sporadically infects humans in West and Central Africa. It first infected humans in 1970 and, along with the variola virus, belongs to the genus in the poxvirus family. Since the World Health Organization declared the MPXV outbreak a "Public Health Emergency of International Concern" on July 23, 2022
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Immunogenicity and Safety of COVID-19 Booster Vaccination: A Population-based Clinical Trial to Identify the Best Vaccination Stratagy J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-28 Daniela Sieghart, Claudia A. Hana, Caroline Dürrschmid, Leonhard X Heinz, Helmuth Haslacher, Markus Zlesak, Giulia Piccini PhD, Alessandro Manenti PhD, Emanuele Montomoli Msc, Anselm Jorda, Clemens Fedrizzi, Timothy Hasenoehrl PhD, Andrej Zdravkovic, Karolina Anderle, Ursula Wiedermann, Susanne Drapalik, Helmut Steinbrecher, Felix Bergmann, Christa Firbas, Galateja Jordakieva, Barbara Wagner, Thomas
Various SARS-CoV-2 variants of concerns (VOCs) characterized by higher transmissibility and immune evasion have emerged. Despite reduced vaccine efficacy against VOCs, currently available vaccines provide protection. Population-based evidence on the humoral immune response after booster vaccination is crucial to guide future vaccination strategies and in preparation for imminent COVID-19 waves. This
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Corrigendum to “First international proficiency study on human papillomavirus testing in cervical cancer screening” [J Clin Virol. 2023 Oct;167:105581] J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-26 Emel Yilmaz, Carina Eklund, Camilla Lagheden, Karin Dahlin Robertsson, Marina Lilja, Miriam Elfström, Laila Sara Arroyo Mühr, Joakim Dillner
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One Health in action: Investigation of the first detected local cluster of fatal borna disease virus 1 (BoDV-1) encephalitis, Germany 2022 J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-23 Merle M. Böhmer, Viola C. Haring, Barbara Schmidt, Franziska S. Saller, Liza Coyer, Lidia Chitimia-Dobler, Gerhard Dobler, Dennis Tappe, Andrea Bonakdar, Arnt Ebinger, Gertrud Knoll, Lisa Eidenschink, Anette Rohrhofer, Hans Helmut Niller, Katharina Katz, Philip Starcky, Martin Beer, Rainer G. Ulrich, Dennis Rubbenstroth, Markus Bauswein
Zoonotic Borna disease virus 1 (BoDV-1) causes fatal encephalitis in humans and animals. Subsequent to the detection of two paediatric cases in a Bavarian municipality in Germany within three years, we conducted an interdisciplinary One Health investigation. We aimed to explore seroprevalence in a local human population with a risk for BoDV-1 exposure as well as viral presence in environmental samples
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Performance of the Xpert™ Mpox PCR assay with oropharyngeal, anorectal, and cutaneous lesion swab specimens J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-23 Gregory L. Damhorst, Kaleb McLendon, Evelyn Morales, Zianya M. Solis, Eric Fitts, Heather B. Bowers, Courtney Sabino, Julie Sullivan, Morgan Greenleaf, John D. Roback, Jonathan A. Colasanti, Anandi N. Sheth, Boghuma K. Titanji, Greg S. Martin, Leda Bassit, Wilbur A. Lam, Anuradha Rao
Anorectal and oropharyngeal exposures are implicated in sexual transmission of mpox, but authorized assays in the United States are only validated with cutaneous lesion swabs. Diagnostic assays for anorectal and oropharyngeal swabs are needed to address potential future outbreaks. The Cepheid Xpert® Mpox is the first point-of-care assay to receive FDA emergency use authorization in the United States
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Human papillomavirus negative high grade cervical lesions and cancers: Suggested guidance for HPV testing quality assurance J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-20 Jean Luc Prétet, Laila Sara Arroyo Mühr, Kate Cuschieri, María Dolores Fellner, Rita Mariel Correa, María Alejandra Picconi, Suzanne M. Garland, Gerald L. Murray, Monica Molano, Michael Peeters, Steven Van Gucht, Charlotte Lambrecht, Davy Vanden Broeck, Elizaveta Padalko, Marc Arbyn, Quentin Lepiller, Alice Brunier, Steffi Silling, Kristiane Søreng, Irene Kraus Christiansen, Mario Poljak, Camilla Lagheden
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
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The value and complexity of studying cellular immunity against BK Polyomavirus in kidney transplant recipients J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-17 Aurélien Aubry, Baptiste Demey, Sandrine Castelain, François Helle, Etienne Brochot
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
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Rapid antigen testing for SARS-CoV-2 by lateral flow assay: A field evaluation of self- and professional testing at UK community testing sites J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-15 Matthias E. Futschik, Samuel Johnson, Elena Turek, David Chapman, Simon Carr, Zareen Thorlu-Bangura, Paul E. Klapper, Malur Sudhanva, Andrew Dodgson, Joanna R. Cole-Hamilton, Nick Germanacos, Raghavendran Kulasegaran-Shylini, Edward Blandford, Sarah Tunkel, Timothy Peto, Susan Hopkins, Tom Fowler
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. Three prospective multi-centre studies were conducted to compare the performance of
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Quality control data management with unity real-time in molecular virology J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-12 Mikayla Quinton, Duane W. Newton, Becky Neil, Sondra Mitchell, Heba H. Mostafa
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
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Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-12 Pedro Pisa, Constance Wose Kinge, Charles Chasela, Eula Mothibi, Yin Min Thaung, Hnin T. Thwin, Nay M. Aung, Kara W. Chew, Malini M. Gandhi, Cavenaugh Clint, Thomas Minior, Aye A. Lwin, Morgan J. Freiman, Khin P. Kyi, Yi Y. Sein, Fadzai Marange, Charles van der Horst, Sofiane Mohamed, Matthieu Barralon, Ian Sanne
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
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Differentiation of highly pathogenic strains of human JC polyomavirus in neurological patients by next generation sequencing J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-12 Eeva Auvinen, Anni Honkimaa, Pia Laine, Sara Passerini, Ugo Moens, Valeria Pietropaolo, Mika Saarela, Leena Maunula, Laura Mannonen, Olli Tynninen, Hannu Haapasalo, Tuomas Rauramaa, Petri Auvinen, Hanna Liimatainen
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). Using next-generation
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QuantiFERON–CMV assay by chemiluminescence immunoassay: Is it more suitable for real-live monitoring of transplant patients? J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-08 Raquel Fernández-Moreno, Aurora Páez-Vega, Diego Rodríguez-Cano, Ana Salinas, Fernando Rodríguez-Cantalejo, Aurora Jurado, Julián Torre-Cisneros, Sara Cantisán
The QuantiFERONCMV (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. The aim of this work is to compare the results of QF-CMV by ELISA with those
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Impact of anti-HDV reflex testing at HBs antigen positive discovery in a single center France: Support for primary HDV screening in France J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-03 Assilina Parfut, Simona Tripon, Pierre Gantner, Fréderic Chaffraix, Elodie Laugel, Marie-Josée Wendling, Furkan Erol, Carine Wiedemer, Michel Doffoel, Antonio Saviano, Maude Royant, François Habersetzer, Samira Fafi-Kremer, Aurélie Velay
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
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Validation of the clinical performance and reproducibility of the NeuMoDx HPV assay self-sample workflow J. Clin. Virol. (IF 8.8) Pub Date : 2024-02-01 D.A.M. Heideman, J. Berkhof, L. Verhoef, C. Ouwerkerk, P.W Smit, A. Oštrbenk Valenčak, J. Mlakar, M. Poljak, R.D.M. Steenbergen, M.C.G. Bleeker
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. 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
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Don't rash it! The clinical significance of positive Varicella zoster virus PCR in cerebrospinal fluid of patients with neurological symptoms J. Clin. Virol. (IF 8.8) Pub Date : 2024-01-22 Or Kriger, Sarah Dovrat, Ilana S. Fratty, Eyal Leshem, Michal Tepperberg Oikawa, Danit Sofer, Sharon Amit
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. In this retrospective
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Evaluation of a custom designed hybridisation assay for whole genome sequencing of human adenoviruses direct from clinical samples J. Clin. Virol. (IF 8.8) Pub Date : 2024-01-11 Emma Ann Davies, Laura Dutton, Malcolm Guiver
Human Adenoviruses are a common cause of disease and can cause significant morbidity and mortality in immunocompromised patients. Nosocomial transmission events can occur with whole genome sequencing playing a crucial role. This study evaluates the performance of a custom designed SureSelect target enrichment assay based on 14 adenovirus genomes for sequencing direct from clinical samples.
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Portable Nanopore sequencing solution for next-generation HIV drug resistance testing J. Clin. Virol. (IF 8.8) Pub Date : 2024-01-09 Sung Yong Park, Gina Faraci, Kevin Ganesh, Michael P. Dubé, Ha Youn Lee
Tackling HIV drug resistance is one of major challenges for ending AIDS epidemic, but the elevated expense of cutting-edge genomics hampers the advancement of HIV genotype testing for clinical care. We developed a HIV genotype testing pipeline that centers on a cost-efficient portable Nanopore sequencer. Accuracy verification was conducted through comparison with parallel data obtained via fixed-site
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Evaluation of an automated real-time transcription-mediated amplification (TMA) assay for detection and quantification of cytomegalovirus DNA in different clinical specimens J. Clin. Virol. (IF 8.8) Pub Date : 2024-01-01 M. Schneider, K. Kollender, B. Hilfrich, R. Weiss, T. Iftner, A. Heim, T. Ganzenmueller
Reliable and fast detection and quantification of human cytomegalovirus (CMV) DNA in various diagnostic specimens is essential for care of immunocompromised or congenitally infected individuals. To evaluate the analytical and clinical performance of the Panther Aptima® CMV (Hologic) quantitative real-time transcription mediated amplification (TMA) assay. Performance of the TMA assay run on the Hologic
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Allplex HPV HR Detection assay fulfils all clinical performance and reproducibility validation requirements for primary cervical cancer screening J. Clin. Virol. (IF 8.8) Pub Date : 2024-01-01 Anja Oštrbenk Valenčak, Kate Cuschieri, Linzi Connor, Andrej Zore, Špela Smrkolj, Mario Poljak
Human papillomavirus (HPV)-based screening offers better protection against cervical cancer compared to cytology, but HPV screening assays must adhere to validation requirements of the international guidelines to ensure optimal performance. Allplex HPV HR Detection (Allplex) assay, launched in the late 2022, is a fully automated real-time PCR-based assay utilizing innovative technology that enables
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Cytomegalovirus detected by qPCR in iris and ciliary body of immunocompetent corneal donors J. Clin. Virol. (IF 8.8) Pub Date : 2024-01-01 Maxime Rocher, Mathilde Duchesne, Déborah Andouard, Laurence Beral, Marc Labriffe, Delphine Chainier, Mélissa Gomes-Mayeras, Sébastien Hantz, Sophie Alain, Pierre-Yves Robert
Cytomegalovirus (CMV) can cause a wide panel of ocular infections. The involvement of CMV as a cause of anterior uveitis in the immunocompetent patient is recent and remains poorly understood. To investigate the presence of CMV in anterior uveal tissues of immunocompetent corneal donors. We collected aqueous humor, iris, and ciliary body from both eyes of 25 donors died at the Limoges University Hospital
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Respiratory syncytial virus-related hospital stays in adults in France from 2012 to 2021: A national hospital database study J. Clin. Virol. (IF 8.8) Pub Date : 2023-12-31 Paul Loubet, Jérôme Fernandes, Gérard de Pouvourville, Katia Sosnowiez, Anne Elong, Caroline Guilmet, Hanane Omichessan, Isabelle Bureau, Francis Fagnani, Corinne Emery, Claire Nour Abou Chakra
Respiratory syncytial virus (RSV) causes lower respiratory tract infections (LRTI) that may lead to hospitalization or death. The present study aimed to assess the burden of RSV infections in hospitalized adults. RSV-related hospitalizations were identified from the nationwide hospital claims database in France (PMSI) from 2012 to 2021 using ICD-10 codes J12.1, J20.5, J21.0 or B97.4, and outcomes assessment
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The diagnostic accuracy of the ID NOW COVID-19 point of care test in acute hospital admissions J. Clin. Virol. (IF 8.8) Pub Date : 2023-12-13 Ameeka Thompson, David Hettle, Stephanie Hutchings, Barry Vipond, Nicholas Veasey, Kerry Grant, Jonathan Turner, Rich Hopes, Jonathan Steer, Rommel Ravanan, O.Martin Williams, Peter Muir
Prompt identification of patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection on admission to hospital is crucial to ensuring initiation of appropriate treatment, optimising infection control and maintaining patient flow. The Abbott ID NOW™ COVID-19 assay (ID NOW) is a point-of-care, isothermal nucleic acid amplification test, capable of producing a result within minutes
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Validation of digital droplet PCR assays for cell-associated HIV-1 DNA, HIV-1 2-LTR circle, and HIV-1 unspliced RNA for clinical studies in HIV-1 cure research J. Clin. Virol. (IF 8.8) Pub Date : 2023-12-07 Jonathan Reed, Ginger Kwak, Eli A. Piliper, Emily J. Degli-Angeli, Erin A. Goecker, Alexander L. Greninger
Cell-associated HIV-1 DNA, HIV-1 2-LTR circle, and HIV-1 unspliced RNA (usRNA) are important virological parameters for monitoring HIV-1 persistence and activation of latent HIV-1. Assays fully validated by CLIA and/or GCLP standards are needed for future clinical trials that seek to evaluate treatments directed towards HIV-1 cure. To determine performance characteristics of sensitive, moderate-throughput
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Development and evaluation of an easy to use real-time reverse-transcription loop-mediated isothermal amplification assay for clinical diagnosis of West Nile virus J. Clin. Virol. (IF 8.8) Pub Date : 2023-12-07 Marwa Khedhiri, Melek Chaouch, Kaouther Ayouni, Anissa Chouikha, Mariem Gdoura, Henda Touzi, Nahed Hogga, Alia Benkahla, Wasfi Fares, Henda Triki
West Nile Virus (WNV) causes a serious public health concern in many countries around the world. Virus detection in pathological samples is a key component of WNV infection diagnostic, classically performed by real-time PCR. In outbreak situation, rapid detection of the virus, in peripheral laboratories or at point of care, is crucial to guide decision makers and for the establishment of adequate action
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Serological assays for differentiating natural COVID-19 infection from vaccine induced immunity J. Clin. Virol. (IF 8.8) Pub Date : 2023-12-01 Samuel M.S. Cheng, Jonathan J. Lau, Leo C.H. Tsang, Kathy Leung, Cheuk Kwong Lee, Asmaa Hachim, Niloufar Kavian, Sara Chaothai, Ricky W.K. Wong, Jennifer K.M. Yu, Zacary Y.H. Chai, Masashi Mori, Chao Wu, Karen Yiu, David S.C. Hui, Gaya K. Amarasinghe, Leo L.M. Poon, Joseph T. Wu, Sophie A. Valkenburg, Malik Peiris
Natural SARS-CoV-2 infection may elicit antibodies to a range of viral proteins including non-structural protein ORF8. RNA, adenovirus vectored and sub-unit vaccines expressing SARS-CoV-2 spike would be only expected to elicit S-antibodies and antibodies to distinct domains of nucleocapsid (N) protein may reliably differentiate infection from vaccine-elicited antibody. However, inactivated whole virus
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Laboratory diagnosis of measles infection using molecular and serology during 2019–2020 outbreak in Brazil J. Clin. Virol. (IF 8.8) Pub Date : 2023-11-29 Etienne Wessler Coan, Felipe Francisco Tuon
Laboratory diagnosis of measles can be challenging, and the reintroduction of the measles virus in Brazil has brought about new issues. The aim of this study was to analyze the qPCR results of swab and urine samples and compare them with those of immunological methods for the diagnosis of measles. This was a cross-sectional study based on a retrospective analysis of 3,451 suspected cases using laboratory
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Recent HIV-1 infection in Israel 2017–2021: Evaluation of geenius and HIV-1/2 combo assays for identifying recent infection detected by Sedia assay and assessment of factors related to recent infection: Recent HIV-1 infection in Israel J. Clin. Virol. (IF 8.8) Pub Date : 2023-11-29 Eyal Azuri, Marina Wax, Yael Gozlan, Tali Wagner, Orna Mor
Estimating HIV-1 recency of infection for incidence and local outbreaks detection usually involves specifically designed assays. Here, we established an approach to identify recent infections, estimate their rate, and assess potential risk factors. Randomly selected HIV-1 positive samples ( = 382) collected in 2017–2021 were tested by Sedia and compared to the results of Geenius recency algorithm and
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Clinical and immunological benefits of full primary COVID-19 vaccination in individuals with SARS-CoV-2 breakthrough infections: A prospective cohort study in non-hospitalized adults J. Clin. Virol. (IF 8.8) Pub Date : 2023-11-28 Martina Prelog, Samuel D. Jeske, Claudia Asam, Andre Fuchs, Andreas Wieser, Christine Gall, Monika Wytopil, Sandra M. Mueller-Schmucker, Stephanie Beileke, Mehmet Goekkaya, Elisabeth Kling, Christof Geldmacher, Raquel Rubio-Acero, Michael Plank, Catharina Christa, Annika Willmann, Martin Vu, Sebastian Einhauser, Manuela Weps, Benedikt M.J. Lampl, Giovanni Almanzar, Kimia Kousha, Valeria Schwägerl,
SARS-CoV-2 variants of concern (VOC) may result in breakthrough infections (BTIs) in vaccinated individuals. The aim of this study was to investigate the effects of full primary (two-dose) COVID-19 vaccination with wild-type-based SARS-CoV-2 vaccines on symptoms and immunogenicity of SARS-CoV-2 VOC BTIs. In a longitudinal multicenter controlled cohort study in Bavaria, Germany, COVID-19 vaccinated
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Enrichment of SARS-CoV-2 sequence from nasopharyngeal swabs whilst identifying the nasal microbiome J. Clin. Virol. (IF 8.8) Pub Date : 2023-11-25 Abdulrahman Alrezaihi, Rebekah Penrice-Randal, Xiaofeng Dong, Tessa Prince, Nadine Randle, Malcolm G. Semple, Peter J.M. Openshaw, ISARIC4C Investigators, Tracy MacGill, Todd Myers, Robert Orr, Samo Zakotnik, Alen Suljič, Tatjana Avšič-Županc, Miroslav Petrovec, Miša Korva, Waleed AlJabr, Julian A. Hiscox
Simultaneously characterising the genomic information of coronaviruses and the underlying nasal microbiome from a single clinical sample would help characterise infection and disease. Metatranscriptomic approaches can be used to sequence SARS-CoV-2 (and other coronaviruses) and identify mRNAs associated with active transcription in the nasal microbiome. However, given the large sequence background
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HTLV-1-associated myelopathy in Spain J. Clin. Virol. (IF 8.8) Pub Date : 2023-11-21 Carmen de-Mendoza, Leire Pérez, Ariadna Rando, Gabriel Reina, Antonio Aguilera, Rafael Benito, José María Eirós, Itziar Rodríguez-Avial, Diego Ortega, María José Pozuelo, María José Pena, Vicente Soriano
Background HTLV-1 infection is a neglected disease. Over 10 million people are infected worldwide, with hot spots of high endemicity across all continents. Roughly 5% of HTLV-1 carriers develop HTLV-1-associated myelopathy (HAM), a progressive subacute neurological disabling disease. Methods We report the main features of patients diagnosed with HAM up to date in Spain, a non-endemic country with a
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Changes in Enterovirus epidemiology after easing of lockdown measures J. Clin. Virol. (IF 8.8) Pub Date : 2023-11-10 Erley Lizarazo Forero, Marjolein Knoester, Lilli Gard, Alewijn Ott, Afke H. Brandenburg, Matthew B.B. Mc Call, Hubert G.M. Niesters, Coretta Van Leer-Buter
Introduction Public health measures aimed at controlling transmission of SARS-CoV-2, otherwise known as “lockdown” measures, had profound effects on circulation of non-SARS viruses, many of which decreased to very low levels. The interrupted transmission of these viruses may have lasting effects. Some of the influenza clades seem to have disappeared during this period, a phenomenon which is described
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Arbovirus surveillance in pregnant women in north-central Nigeria, 2019–2022 J. Clin. Virol. (IF 8.8) Pub Date : 2023-11-03 Jerry Ogwuche, Charlotte Ajeong Chang, Olukemi Ige, Atiene S. Sagay, Beth Chaplin, Makshwar L. Kahansim, Michael Paul, Michael Elujoba, Godwin Imade, Georgenia Kweashi, Yu-Ching Dai, Szu-Chia Hsieh, Wei-Kung Wang, Donald J. Hamel, Phyllis J. Kanki
Background The adverse impact of Zika (ZIKV), dengue (DENV), and chikungunya (CHIKV) virus infection in pregnancy has been recognized in Latin America and Asia but is not well studied in Africa. Although originally discovered in sub-Saharan Africa the non-specific clinical presentation of arbovirus infection may have hampered our detection of adverse clinical outcomes and outbreak. Objective This prospective
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Clinical and molecular characteristics of the 2022 Enterovirus-D68 outbreak among hospitalized children, Ohio, USA J. Clin. Virol. (IF 8.8) Pub Date : 2023-11-04 Raquel Giacomelli Cao, Asuncion Mejias, Amy L. Leber, Huanyu Wang
Background Enterovirus-D68 (EV-D68) has appeared biennially in the United States following the 2014 outbreak. It has gained epidemiologic and clinical relevance and was identified as an important pathogen associated with severe respiratory and central nervous system diseases. We aim to describe the clinical and molecular characteristics of the post-pandemic 2022 Enterovirus-D68 outbreak in children
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Opt-out testing for hepatitis B and C infections in adults attending the emergency department of a large London teaching hospital J. Clin. Virol. (IF 8.8) Pub Date : 2023-10-30 Jingwei Zeng, Douglas Macdonald, Russell Durkin, Dianne Irish, Jennifer Hart, Tanzina Haque
Background The National Health Service (NHS) in England commissioned opt-out testing in London Emergency Departments (ED) in April 2022 to allow early identification and management of hepatitis B (HBV) and hepatitis C virus (HCV) infection in patients unaware of their infection status. Methods All adults over the age of 16 undergoing blood tests in the ED at the Royal Free Hospital were tested for
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Comparison of two serological screening strategies for cytomegalovirus primary infection in the first trimester of pregnancy J. Clin. Virol. (IF 8.8) Pub Date : 2023-10-24 Jacques Fourgeaud, Chiêu-Ân Nguyen, Tiffany Guilleminot, Yves Ville, Marianne Leruez-Ville
Introduction CMV serology screening in the first trimester pregnancy is based on IgG and IgM testing followed by IgG avidity in cases with positive IgM. However, the sensitivity of this strategy to diagnose maternal primary infection has been questioned. The objective of the study was to compare this strategy 1 with a strategy 2 consisting of running avidity test on all samples with positive IgG (ignoring
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Molecular point-of-care devices for the diagnosis of infectious diseases in resource-limited settings – A review of the current landscape, technical challenges, and clinical impact J. Clin. Virol. (IF 8.8) Pub Date : 2023-10-18 Kenneth Gavina, Lauren C. Franco, Haseeba Khan, John-Paul Lavik, Ryan F. Relich
Molecular point-of-care (POC) tests offer high sensitivity, rapid turnaround times, relative ease of use, and the convenience of laboratory-grade testing in the absence of formal laboratory spaces and equipment, making them appealing options for infectious disease diagnosis in resource-limited settings. In this review, we discuss the role and potential of molecular POC tests in resource-limited settings
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Viral pathogen detection using multiplex gastrointestinal molecular panels: The pros and cons of viral target inclusion J. Clin. Virol. (IF 8.8) Pub Date : 2023-10-15 Eleanor A. Powell, D. Jane Hata, Meghan W. Starolis
Diagnosis of gastrointestinal infections has been revolutionized by the development of in vitro diagnostic (IVD) multiplex molecular panels for the detection of viral nucleic acids. In addition to a high degree of accuracy, these panels are commercially available and relatively simple to perform in the clinical laboratory. However, use of these panels must be carefully considered owing to the laboratory
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Predictors of chronic joint pain after Chikungunya virus infection in the INOVACHIK prospective cohort study J. Clin. Virol. (IF 8.8) Pub Date : 2023-10-08 Ezequias B. Martins, Marcel S.B. Quintana, Michele F.B. Silva, Fernanda de Bruycker-Nogueira, Isabella C.V. Moraes, Cintia D.S. Rodrigues, Carolina C. Santos, Simone A. Sampaio, Anielle Pina-Costa, Allison A. Fabri, Vinícius Guerra-Campos, Nieli R.C. Faria, Ana Maria B. Filippis, Patrícia Brasil, Guilherme A. Calvet
Background Chikungunya can cause persistent chronic joint pain. Knowledge of the risk factors for disease progression is important for preventing and controlling complications. This study aimed to identify factors associated with chronic joint pain. Methods This prospective cohort study was conducted at a reference center in Rio de Janeiro. Men and women (aged ≥ 18 years) in the acute phase of Chikungunya
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Detection of varicella zoster virus DNA in blood from immunocompromised patients during the week preceding the onset of herpes zoster rash J. Clin. Virol. (IF 8.8) Pub Date : 2023-10-08 Vincent Guiraud, Henri Thévenet, David Boutolleau
Objective To assess whether varicella zoster virus (VZV) DNA can be detected in blood before herpes zoster (HZ) rash onset. Method Monocentric retrospective study from January 2019 to March 2023 including patients with HZ and stored blood samples performed during the week preceding the onset of HZ rash. Blood samples were retrospectively analyzed for VZV DNA by quantitative PCR. Results Among the 138
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FDA trial regulation of laboratory developed tests (LDTs): An academic medical center's experience with Mpox in-house testing J. Clin. Virol. (IF 8.8) Pub Date : 2023-10-10 JR Caldera, Hannah K. Gray, Omai B. Garner, Shangxin Yang
The 2022 mpox outbreak presented a familiar challenge to clinical laboratories. Accordingly, our institution was able to swiftly implement in-house mpox testing to meet the imminent diagnostic needs of the public health emergency. While the FDA authorized laboratory-developed tests (LDTs) for lesion specimens, however, it restricted the testing of rectal swabs despite mounting evidence of its clinical
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Comparing COVID-19 and influenza: Epidemiology, clinical characteristics, outcomes and mortality in the ICU J. Clin. Virol. (IF 8.8) Pub Date : 2023-10-10 Quentin Pangot, François Labaste, Vincent Pey, Chloé Médrano, Adam Tuijnman, Stéphanie Ruiz, Jean-Marie Conil, Vincent Minville, Fanny Vardon-Bounes
Rationale Several authors have compared COVID-19 infection with influenza in the ICU. Objective This study aimed to compare the baseline clinical profiles, care procedures, and mortality outcomes of patients admitted to the intensive care unit, categorized by infection status (Influenza vs. COVID-19). Methods Retrospective observational study. Data were extracted from the Toulouse University Hospital
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Detection of early phase human T-cell leukemia virus type 1 and 2 infection with an improved confirmatory test J. Clin. Virol. (IF 8.8) Pub Date : 2023-09-20 Yasuko Sagara, Hitomi Nakamura, Masahiro Satake, Koji Matsuzaki
Background Human T-cell leukemia virus type 1 (HTLV-1) is a blood-borne virus, and mandatory testing of donated blood for HTLV-1 antibodies has been adopted by Japanese Red Cross blood centers since 1986. A confirmatory line immunoassay was initiated in 2019 for individuals who were seroreactive in the screening test. This decreased the incidence of indeterminate individuals, however, donors with indeterminate
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DENV-1 genotype V linked to the 2022 dengue epidemic in Southern Brazil J. Clin. Virol. (IF 8.8) Pub Date : 2023-09-21 Juliana Schons Gularte, Lívia Sacchetto, Meriane Demoliner, Viviane Girardi, Mariana Soares da Silva, Micheli Filippi, Vyctoria Malayhka de Abreu Góes Pereira, Alana Witt Hansen, Luana Letícia da Silva, Juliane Deise Fleck, Paula Rodrigues de Almeida, Maurício Lacerda Nogueira, Fernando Rosado Spilki
Even though Brazil is a country where the dengue virus (DENV) is endemic, until recently, Southern states did not have significant viral circulation, such as Rio Grande do Sul (RS), and some municipalities were even considered dengue-free. During 2022, these places have shown a sharp increase in the incidence of the disease, apparently following a worldwide growth pattern. Therefore, in this study
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A study to assess the impact of the cobas point-of-care RT-PCR assay (SARS-CoV-2 and Influenza A/B) on patient clinical management in the emergency department of the University of California at Davis Medical Center J. Clin. Virol. (IF 8.8) Pub Date : 2023-09-18 Larissa May, Elissa M. Robbins, Jesse A. Canchola, Kamal Chugh, Nam K. Tran
Background Rapid detection of SARS-CoV-2 is crucial for reduction of transmission and clinical decision-making. Several rapid (<30 min) molecular point-of-care (POC) tests based on nucleic acid amplification exist for diagnosis of SARS-CoV-2 & Influenza A/B infections. Methods This unblinded, pre-post study enrolled consecutive patients with symptoms/signs consistent with SARS-CoV-2 infection presenting
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Impaired neutralizing antibody efficacy of tixagevimab-cilgavimab 150+150 mg as pre-exposure prophylaxis against Omicron BA.5. A real-world experience in booster vaccinated immunocompromised patients J. Clin. Virol. (IF 8.8) Pub Date : 2023-09-17 Elisabetta Schiaroli, Anna Gidari, Giovanni Brachelente, Giulia Bicchieraro, Roberta Spaccapelo, Sabrina Bastianelli, Sara Pierucci, Chiara Busti, Carlo Pallotto, Lisa Malincarne, Barbara Camilloni, Flavio Falcinelli, Giuseppe Vittorio De Socio, Alfredo Villa, Antonella Mencacci, Daniela Francisci
Background Tixagevimab-cilgavimab has been approved as primary pre-exposure prophylaxis in immunocompromised patients as support or replacement for vaccination, even though the Omicron variant of concern (VOC) was spreading at the time. Objectives The aim of our study was to evaluate the post-injection neutralising activity (NT90-Abs titre) against the Omicron BA.5 variant in fully vaccinated immunocompromised
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Whole genome sequencing reveals insights into hepatitis E virus genome diversity, and virus compartmentalization in chronic hepatitis E J. Clin. Virol. (IF 8.8) Pub Date : 2023-09-12 Julia Melchert, Helena Radbruch, Leif G. Hanitsch, Sally A. Baylis, Jörn Beheim-Schwarzbach, Tobias Bleicker, Jörg Hofmann, Terry C. Jones, Christian Drosten, Victor M. Corman
Background Hepatitis E virus (HEV) is a leading cause of acute hepatitis and can cause chronic infections in immunocompromised patients. Although HEV infections can be treated with ribavirin, antiviral efficacy is hampered by resistance mutations, normally detected by virus sequencing. Objectives High-throughput sequencing (HTS) allows for cost-effective complete viral genome sequencing. This enables
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Assessment of an automated Cytomegalovirus nucleic acid amplification test using clinical plasma, bronchoalveolar lavage, and tissue specimens J. Clin. Virol. (IF 8.8) Pub Date : 2023-09-09 ChunHong Huang, Daniel Solis, Malaya K. Sahoo, Benjamin A. Pinsky
Background Cytomegalovirus (CMV) causes significant morbidity and mortality in immunocompromised patients, particularly transplant recipients. Quantitation of CMV DNA in peripheral blood is used to monitor prophylactic and pre-emptive approaches to prevent CMV disease, whereas CMV DNA testing of non-plasma specimens may aid in the diagnosis of end-organ disease. Methods The analytical performance of
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Laboratory evaluation of ELISA and indirect immunofluorescence assay in response to emergence of Japanese encephalitis virus genotype IV in Australia J. Clin. Virol. (IF 8.8) Pub Date : 2023-09-09 Paul Kinsella, Michael Moso, Genevieve Martin, Theo Karapangiotidis, Di Karamalakis, Suellen Nicholson, Mitch Batty, Kathy Jackson, Madeleine Marsland, Tilda Thompson, Lakshmi Manoharan, Helen O'brien, Deborah Friedman, Katherine Bond, Deborah A. Williamson, Chuan Kok Lim
The unexpected recent emergence of Japanese encephalitis virus (JEV) genotype IV in multiple southern states of Australia necessitated an evaluation of JEV serological tests suitable for diagnosing acute infection and for seroprevalence studies. This study examined the analytical and clinical performance of two high-throughput JEV assays, Euroimmun immunofluorescence assay (IFA) and Euroimmun enzyme-linked
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First international proficiency study on human papillomavirus testing in cervical cancer screening J. Clin. Virol. (IF 8.8) Pub Date : 2023-09-04 Emel Yilmaz, Carina Eklund, Camilla Lagheden, Karin Dahlin Robertsson, Marina Lilja, Miriam Elfström, Laila Sara Arroyo Mühr, Joakim Dillner
Background Although cervical screening using Human Papillomavirus (HPV) testing is globally recommended public health policy, there has been no international proficiency studies specifically targeting HPV testing for cervical screening. Objective To obtain the first global overview of the current proficiency of HPV testing services for cervical cancer screening. Study design A coded proficiency panel
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A prospective evaluation of the diagnostic potential of EBV-DNA in plasma and whole blood J. Clin. Virol. (IF 8.8) Pub Date : 2023-08-30 Lene Ugilt Pagter Ludvigsen, Annemette Sloth Andersen, Stephen Hamilton-Dutoit, Søren Jensen-Fangel, Pernille Bøttger, Kurt Jensen Handberg, Per Ivarsen, Francesco d'Amore, Bo Martin Bibby, Birgitte Klug Albertsen, Bente Jespersen, Marianne Kragh Thomsen
Background Quantitative polymerase chain reaction (qPCR) for Epstein–Barr virus (EBV)-DNA is an important diagnostic tool for EBV-associated disease, but interpretation of its clinical significance is challenging. Objectives We assessed the diagnostic and clinical performance of WHO-standardised qPCR for EBV-DNA (WHO EBV-qPCR) in plasma and whole blood (WB) for proven EBV disease in a prospectively
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Implementing a multiplex-PCR test for the diagnosis of acute gastroenteritis in hospitalized children: Are all enteric viruses the same? J. Clin. Virol. (IF 8.8) Pub Date : 2023-08-25 Dana Danino, Guy Hazan, Rofaida Mahajna, Firas Khalde, Lama Farraj, Yonat Shemer Avni, David Greenberg, Eli Hershkovitz, Yaniv Faingelernt, Noga Givon-Lavi
Background Multiplex-PCR is a valuable tool for diagnosing viral acute gastroenteritis (AGE), enabling the detection of multiple pathogens. However, distinguishing between active disease and shedding poses challenges. This study aimed to evaluate viral AGE epidemiology and compare clinical characteristics among the five most common viruses. Methods Rotavirus vaccine was introduced in 2010, with 70%
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Adult T-cell leukemia/lymphoma in HTLV-1 non-endemic regions J. Clin. Virol. (IF 8.8) Pub Date : 2023-08-28 Carmen de Mendoza, Ariadna Rando, Elisenda Miró, María José Pena, Iciar Rodríguez-Avial, Diego Ortega, Alejandro González-Praetorius, Gabriel Reina, Ilduara Pintos, María José Pozuelo, Vicente Soriano
Background HTLV-1 infection is a neglected disease, despite producing neurological and lymphoproliferative severe illnesses and affect over 10 million people worldwide. Roughly 5% of HTLV-1 carriers develop Adult T-cell leukemia/lymphoma (ATLL), one of the most aggressive hematological malignancies. Methods A national HTLV-1 register exists since 1989 in Spain, a non-endemic country with a large migrant
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Post-COVID-19 pandemic outbreak of severe Parvovirus B19 primary infections in Paris, France: 10-year interrupted time-series analysis (2012–2023) J. Clin. Virol. (IF 8.8) Pub Date : 2023-08-22 Jacques Fourgeaud, Slimane Allali, Julie Toubiana, Yael Pinhas, Pierre Frange, Marianne Leruez-Ville, Jérémie F. Cohen
Abstract not available
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Swab pooling enables rapid expansion of high-throughput capacity for SARS-CoV-2 community testing J. Clin. Virol. (IF 8.8) Pub Date : 2023-08-19 Jamie Fagg, Rupert Beale, Matthias E. Futschik, Elena Turek, David Chapman, Susan Halstead, Marc Jones, Joanna Cole-Hamilton, Rory Gunson, Malur Sudhanva, Paul E. Klapper, Harper Vansteenhouse, Sarah Tunkel, Anna Dominiczak, Timothy EA Peto, Tom Fowler