Journal of Clinical Virology最新文献

{"title":"Resurgence of common respiratory viruses in patients with community-acquired pneumonia (CAP)—A prospective multicenter study","authors":"Theo Dähne ,&nbsp;Wolfgang Bauer ,&nbsp;Andreas Essig ,&nbsp;Bernhard Schaaf ,&nbsp;Grit Barten-Neiner ,&nbsp;Christoph D. Spinner ,&nbsp;Mathias W. Pletz ,&nbsp;Gernot Rohde ,&nbsp;Jan Rupp ,&nbsp;Martin Witzenrath ,&nbsp;Marcus Panning","doi":"10.1016/j.jcv.2024.105694","DOIUrl":"https://doi.org/10.1016/j.jcv.2024.105694","url":null,"abstract":"<div><h3>Background</h3><p>Community-acquired pneumonia (CAP) is a major global cause of death and hospitalization. Bacteria or community-acquired viruses (CARVs) cause CAP. COVID-19 associated restrictions effectively reduced the circulation of CARVs.</p></div><div><h3>Objectives</h3><p>The aim of this study was to analyze the proportion of CARVs in adult patients with CAP from mid-2020 to mid-2023. Specifically, we aimed to compare the rate of influenza virus, SARS-CoV-2, and RSV detections in patients aged 18–59 years and ≥60 years.</p></div><div><h3>Study design</h3><p>We analyze the proportion of 21 community-acquired respiratory viruses (CARVs) and three atypical bacteria (<em>Bordetella pertussis, Legionella pneumophila</em>, and <em>Mycoplasma pneumoniae</em>) in nasopharyngeal swab samples using molecular multiplex methods within the prospective, multicentre, multinational study of the German study Group CAPNETZ. We used stringent inclusion criteria throughout the study.</p></div><div><h3>Results</h3><p>We identified CARVs in 364/1,388 (26.2 %) patients. In detail, we detected SARS-CoV-2 in 210/1,388 (15.1 %), rhino-/enterovirus in 64/1,388 (4.6 %), influenza virus in 23/1,388 (1.6 %) and RSV in 17/1,388 (1.2 %) of all patients. We detected RSV and influenza more frequently in patients ≥60 years, especially in 22/23 compared to the previous season. None of the atypical bacteria were detected.</p></div><div><h3>Conclusions</h3><p>Beginning in 2023, we demonstrate a re-emergence of CARVs in CAP patients. Effective vaccines or specific antiviral therapies for more than two thirds of the detected viral infections are currently available. High detection rates of vaccine-preventable viruses in older age groups support targeted vaccination campaigns.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"173 ","pages":"Article 105694"},"PeriodicalIF":8.8,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000568/pdfft?md5=2f2377eb7ebe1dce67f90f74cb282d26&pid=1-s2.0-S1386653224000568-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141083391","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":"Analytical and clinical validation of a novel, laboratory-developed, modular multiplex-PCR panel for fully automated high-throughput detection of 16 respiratory viruses","authors":"Hui Ting Tang ,&nbsp;Dominik Nörz ,&nbsp;Moritz Grunwald,&nbsp;Katja Giersch,&nbsp;Susanne Pfefferle,&nbsp;Nicole Fischer,&nbsp;Martin Aepfelbacher,&nbsp;Holger Rohde,&nbsp;Marc Lütgehetmann","doi":"10.1016/j.jcv.2024.105693","DOIUrl":"10.1016/j.jcv.2024.105693","url":null,"abstract":"<div><h3>Background</h3><p><strong>:</strong> Viral respiratory Infections pose a health risk, especially to vulnerable patient populations. Effective testing programs can detect and differentiate these infections at an early stage, which is particularly important for high-risk clinical departments. The objective of this study was to develop and validate a multiplex PCR-panel for 16 different respiratory viruses on a fully-automated high-throughput platform.</p></div><div><h3>Methods</h3><p>Three multiplex-PCR assays were designed to run on the cobas5800/6800/8800 systems, consolidating 16 viral targets: RESP1: SARS-CoV-2, influenza-A/B, RSV; RESP2: hMPV, hBoV, hAdV, rhino-/ENV; RESP3: HPIV-1–4, hCoV-229E, hCoV-NL63, hCoV-OC43, hCoV-HKU1. Analytic performance was evaluated using digital-PCR based standards and international reference material. Clinical performance was determined by comparing results from clinical samples with reference assays.</p></div><div><h3>Results</h3><p>Analytical sensitivity (i.e. lower limit of detection (LoD), 95 % probability of detection) was determined as follows: SARS-CoV-2: 29.3 IU/ml, influenza-A: 179.9 cp/ml, influenza-B: 333.9 cp/ml and RSV: 283.1 cp/ml. LoDs of other pathogens ranged between 9.4 cp/ml (hCoV-NL63) and 21,419 cp/ml (HPIV-2). Linearity was verified over 4–7 log-steps with pooled standard differentials (SD) ranging between 0.18–0.70ct. Inter-/intra-run variability (precision) was assessed for all targets over 3 days. SDs ranged between 0.13–0.74ct. Positive agreement in clinical samples was 99.4 % and 95 % for SARS-CoV-2 and influenza-A respectively. Other targets were in the 80–100 % range. Negative agreement varied between 96.3–100 %.</p></div><div><h3>Discussion</h3><p>Lab-developed tests are a key factor for effective clinical diagnostics. The multiplex panel presented in this study demonstrated high performance and provides an easily scalable high-throughput solution for respiratory virus testing, e.g. for testing in high-risk patient populations.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"173 ","pages":"Article 105693"},"PeriodicalIF":8.8,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000556/pdfft?md5=6da38b25c92dba819b4157dad492192a&pid=1-s2.0-S1386653224000556-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141039866","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":"Clinical presentation, viral shedding, and neutralizing antibody responses of mpox cases in South Korea: Single center experience","authors":"BumSik Chin ,&nbsp;Jihye Um ,&nbsp;Min-Kyung Kim ,&nbsp;Hyang Su Kim ,&nbsp;Hong Soon Yim ,&nbsp;Hyee Jin Cho ,&nbsp;So Yun Lim ,&nbsp;Yeonjae Kim ,&nbsp;Jaehyun Jeon ,&nbsp;Jun-Sun Park","doi":"10.1016/j.jcv.2024.105692","DOIUrl":"10.1016/j.jcv.2024.105692","url":null,"abstract":"<div><h3>Background</h3><p>A global mpox outbreak occurred in 2022, and a domestic outbreak started in South Korea in April 2023. This study aimed to evaluate the clinical characteristics, viral shedding, and immune response of mpox in South Korea.</p></div><div><h3>Methods</h3><p>Patients hospitalized with mpox in the National Medical Center between September 2022 and June 2023 were included in this study. Oropharyngeal (OP), anogenital lesion (AL), and skin lesion (SL) swabs and blood samples were collected, and monkeypox virus (MPXV) DNA using real-time polymerase chain reaction (RT-PCR) and culture assays were performed. Neutralizing antibodies (NAbs) against MPXV A.2.1, B.1.1, and B.1.3 were detected using plaque reduction neutralization tests.</p></div><div><h3>Results</h3><p>Eighteen patients were enrolled, of whom 17 (94.4 %) were male, with a median (IQR) age of 32.5 (24–51) years. While nine (50 %) were HIV-infected individuals, none of them revealed CD4+ counts less than 200 cells/μL. MPXV DNA was detected in 87.3 % and 82.7 % of patient's ALs and SLs, respectively, until 2 weeks after symptom onset. While MPXV was isolated for up to 15 days in all three sample types, the culture positivity decreased to 53.8 % and 42.9 % in ALs and SLs after 10 days, respectively, and 28.6 % and 22.2 %, respectively, after 2 weeks from symptom onset. The NAb titers against MPXV A.2.1 were significantly lower than those against B.1.1 and B.1.3.</p></div><div><h3>Conclusions</h3><p>Infectious MPXV was isolated from various anatomical sites up to 15 days after symptom onset. The MPXV NAb response was varied among different lineages, and this implies limited cross-lineage protection.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"173 ","pages":"Article 105692"},"PeriodicalIF":8.8,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000544/pdfft?md5=72fb19102f3a57fd2831abe390bf7d9a&pid=1-s2.0-S1386653224000544-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141028829","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":"Clinical evaluation of a novel digital microfluidic based point-of-care test platform for detection of SARS-Cov-2 and influenza A/B","authors":"Huitao Huang ,&nbsp;Dongling Long ,&nbsp;Yixiong Lin ,&nbsp;Cheng Dong ,&nbsp;Wenyan Huang ,&nbsp;Mengjuan Zhang ,&nbsp;Liang Wan ,&nbsp;Hongna Gou ,&nbsp;Tianlan Chen ,&nbsp;Fei Li","doi":"10.1016/j.jcv.2024.105688","DOIUrl":"10.1016/j.jcv.2024.105688","url":null,"abstract":"<div><p>Respiratory pathogens, such as SARS-CoV-2 and influenza A/B, can cause severe illnesses in susceptible individuals. This research evaluated a novel digital microfluidic point-of-care testing platform designed to detect 23 pathogens, comparing its performance to conventional laboratory-based nucleic acid tests. The platform integrates nucleic acid extraction and amplification processes for rapid detection with only 2 min of hands-on time. Performance assays demonstrated that the platform has high sensitivity (87 %-100 %) and specificity (99 %-100 %) for the detection of the evaluated 3 viruses. Additionally, the platform can be adapted for the detection of other respiratory pathogens, aiding in the early diagnosis of respiratory diseases, identifying the source of an outbreak or epidemic, and curbing the spread of the disease.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"173 ","pages":"Article 105688"},"PeriodicalIF":8.8,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141048859","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":"Prospective comparison of cytomegalovirus quantification in whole blood and plasma samples among hematopoietic stem cell transplant and kidney transplant recipients","authors":"Marion Helary ,&nbsp;Nathalie Schnepf ,&nbsp;Nadia Mahjoub ,&nbsp;Mathilde Lacroix ,&nbsp;Alienor Xhaard ,&nbsp;Gillian Divard ,&nbsp;Constance Delaugerre ,&nbsp;Lucie Biard ,&nbsp;Jérôme LeGoff ,&nbsp;Linda Feghoul","doi":"10.1016/j.jcv.2024.105690","DOIUrl":"10.1016/j.jcv.2024.105690","url":null,"abstract":"<div><h3>Background</h3><p>Cytomegalovirus (CMV) induces multi-organ pathogenesis in hematopoietic stem cell transplant (HSCT) and kidney transplant (KT) recipients. Effective management involves systematic monitoring for CMV reactivation by quantitative real-time PCR, allowing timely preemptive intervention. However, the optimal blood compartment for CMV surveillance remains undetermined.</p></div><div><h3>Objective</h3><p>The aim of the study was to compare the quantification of CMV DNA in paired plasma and whole blood samples.</p></div><div><h3>Study design</h3><p>From June and October 2022, we conducted a prospective study with 390 sets of paired plasma and whole blood specimens collected from 60 HSCT and 24 KT recipients. CMV DNA levels were compared between the cobas® CMV assay on the automated cobas® 6800 system for plasma and the reference assay, Abbott RealTime CMV assay on the m2000 RealTime platform for whole blood.</p></div><div><h3>Results</h3><p>The sensitivity and specificity of CMV quantification in plasma using the cobas® CMV assay were 90.0 % (95 %CI: 81.5 to 95.9) and 94.8 % (95 %CI: 91.8 to 96.8), respectively, compared to whole blood quantification with the Abbott assay. The overall agreement between these two strategies was 0.89 (95 %CI: 0.86–0.91). In samples with quantifiable results, a correlation was observed between the two methods (R² = 0.62, 95 %CI: 0.65–0.87, <em>p</em> &lt; 0.0001). CMV loads were significantly higher in whole blood, with a mean bias of 0.42 log₁₀ IU/mL (95 %CI: -0.32–1.15).</p></div><div><h3>Conclusion</h3><p>The cobas® CMV assay in plasma showed significant concordance with the Abbott RealTime CMV assay in whole blood, confirming the relevance of plasma samples for CMV monitoring in HSCT and KT recipients.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"174 ","pages":"Article 105690"},"PeriodicalIF":8.8,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141048488","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":"Evolution, recombination and geographic spreading of global Coxsackievirus A6","authors":"Huanhuan Lu ,&nbsp;Jinbo Xiao ,&nbsp;Yang Song ,&nbsp;Dongmei Yan ,&nbsp;Shuangli Zhu ,&nbsp;Qian Yang ,&nbsp;Tianjiao Ji ,&nbsp;Zhenzhi Han ,&nbsp;Jichen Li ,&nbsp;Ruyi Cong ,&nbsp;Ying Liu ,&nbsp;Haiyan Wei ,&nbsp;Qiong Ge ,&nbsp;Dajin Xiao ,&nbsp;Yingying Liu ,&nbsp;Xiaofang Zhou ,&nbsp;Wei Huang ,&nbsp;Hanri Zeng ,&nbsp;Leilei Wei ,&nbsp;Renqing Li ,&nbsp;Yong Zhang","doi":"10.1016/j.jcv.2024.105691","DOIUrl":"10.1016/j.jcv.2024.105691","url":null,"abstract":"<div><h3>Background</h3><p>The increasing incidence of hand, foot, and mouth disease (HFMD) associated with Coxsackievirus A6 (CVA6) has become a very significant public health problem. The aim of this study is to investigate the recombination, geographic transmission, and evolutionary characteristics of the global CVA6.</p></div><div><h3>Methods</h3><p>From 2019 to 2022, 73 full-length CVA6 sequences were obtained from HFMD patients in China and analyzed in combination with 1032 published whole genome sequences. Based on this dataset, the phylogenetic features, recombinant diversity, Bayesian phylodynamic characteristics, and key amino acid variations in CVA6 were analyzed.</p></div><div><h3>Results</h3><p>The four genotypes of CVA6, A, D, E, and F, are divided into 24 recombinant forms (RFs, RF-A – RF-X) based on differences in the <em>P3</em> coding region. The eastern China region plays a key role in the dissemination of CVA6 in China. VP1–137 and VP1–138 are located in the DE loop on the surface of the CVA6 VP1 protein, with the former being a highly variable site and the latter having more non-synonymous substitutions.</p></div><div><h3>Conclusions</h3><p>Based on whole genome sequences, this study contributes to the CVA6 monitoring, early warning, and the pathogenic mechanism by studying recombination diversity, geographical transmission characteristics, and the variation of important amino acid sites.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"173 ","pages":"Article 105691"},"PeriodicalIF":8.8,"publicationDate":"2024-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140943674","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":"Sequence analysis of respiratory syncytial virus cases reveals a novel subgroup -B strain circulating in north-central Italy after pandemic restrictions","authors":"Alessandra Pierangeli ,&nbsp;Fabio Midulla ,&nbsp;Antonio Piralla ,&nbsp;Guglielmo Ferrari ,&nbsp;Raffaella Nenna ,&nbsp;Antonino Maria Guglielmo Pitrolo ,&nbsp;Amelia Licari ,&nbsp;Gian Luigi Marseglia ,&nbsp;Dario Abruzzese ,&nbsp;Laura Pellegrinelli ,&nbsp;Cristina Galli ,&nbsp;Sandro Binda ,&nbsp;Danilo Cereda ,&nbsp;Matteo Fracella ,&nbsp;Giuseppe Oliveto ,&nbsp;Roberta Campagna ,&nbsp;Laura Petrarca ,&nbsp;Elena Pariani ,&nbsp;Guido Antonelli ,&nbsp;Fausto Baldanti","doi":"10.1016/j.jcv.2024.105681","DOIUrl":"https://doi.org/10.1016/j.jcv.2024.105681","url":null,"abstract":"<div><h3>Background</h3><p>Following the pandemic restrictions, the epidemiology of respiratory syncytial virus (RSV) has changed, leading to intense hospitalization peaks.</p></div><div><h3>Objectives</h3><p>This study, conducted at multiple sites in Italy, aimed to describe the temporal dynamics of two post-COVID-19 RSV epidemics. Additionally, the circulating RSV-A and -B lineages were characterized and compared to those found in 2018 and 2019.</p></div><div><h3>Study design</h3><p>Respiratory specimens and data were collected from RSV-positive patients, both inpatients, and outpatients, of all ages at three sites in north-central Italy. To analyze these samples, roughly one-sixth were sequenced in the attachment glycoprotein G gene and subjected to phylogenetic and mutational analyses, including pre-pandemic sequences from north-central Italy.</p></div><div><h3>Results</h3><p>The first post-pandemic surge of RSV cases was quite intense, occurring from October 2021 to early January 2022. The subsequent RSV epidemic (from November 2022 to early March 2023) also had a high impact, characterized by a rise in elderly patient cases. Post-pandemic cases of RSV-A were caused by various strains present in Italy prior to COVID-19. In contrast, a distinct RSV-B lineage, which was concurrently spreading in other countries, was identified as the main cause of the surge in 2022–2023 but remained undetected in Italy before the pandemic.</p></div><div><h3>Conclusions</h3><p>This study describes the temporal dynamics of post-pandemic RSV subgroups and uncovers a lineage of RSV-B with high genetic divergence that may have increased the impact of decreased population immunity.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"173 ","pages":"Article 105681"},"PeriodicalIF":8.8,"publicationDate":"2024-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S138665322400043X/pdfft?md5=87c6b5e5ee92124e35ee607621411bbb&pid=1-s2.0-S138665322400043X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140906155","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 a fully automated high-throughput serology assay for detection of Hepatitis D virus antibodies","authors":"Xiaoxing Qiu ,&nbsp;Abbas Hadji ,&nbsp;Ana Olivo ,&nbsp;Austin Hodges ,&nbsp;Carla Beertsen ,&nbsp;Mark Anderson ,&nbsp;Mary Rodgers ,&nbsp;Dora Mbanya ,&nbsp;Susan Elaborot ,&nbsp;Gavin Cloherty","doi":"10.1016/j.jcv.2024.105689","DOIUrl":"10.1016/j.jcv.2024.105689","url":null,"abstract":"<div><h3>Background</h3><p>HDV antibody testing is recommended for universal screening and as the first line in an HDV double reflex testing strategy for effectively identifying patients with active infection for therapeutic treatments.</p></div><div><h3>Objective</h3><p>The aim of this study is to evaluate the performance of a newly developed ARCHITECT HDV Total Ig (ARCHITECT HDV Ig) prototype assay.</p></div><div><h3>Study design</h3><p>Performance characteristics were determined for the ARCHITECT HDV Ig and a reference test, LIAISON XL Anti-HDV using a well-characterized specimen panel, comprising HDV RNA positive (n = 62) and negative (n = 70) samples, and healthy US blood donors.</p></div><div><h3>Results</h3><p>Healthy US blood donors (n=200) showed 99.5% (199/200, 95%CI=97.65–99.98) specificity with ARCHITECT HDV Ig and 98.5 % (197/200, 95 %CI = 96.10–99.64) with LIAISON Anti-HDV. Among known HDV RNA positive samples, ARCHITECT HDV Ig detected 59/62 demonstrating 95.2 % sensitivity while LIAISON Anti-HDV sensitivity was 90.3 % (56/62). Among 101 HBV positive samples, 70 were reactive in the ARCHITECT test, 59 of which tested positive for HDV RNA for a positive predictive value (PPV) for the presence of HDV RNA was 84.3 %. For LIAISON Anti-HDV, 79 specimens were reactive and 56 contained HDV RNA: PPV for HDV RNA was 70.9 %. Among 70 HDV RNA negative samples, 39 were HBV positive. ARCHITECT HDV Ig negative predictive value (NPV) was 71.8 % and LIAISON Anti-HDV NPV was 41 % for the HBV positive group, respectively.</p></div><div><h3>Conclusion</h3><p>When compared to the LIASON Anti-HDV test, the ARCHITECT HDV Ig assay demonstrated enhanced sensitivity and specificity and better NPV and PPV values for HDV RNA status. The ARCHITECT HDV Ig assay represents a promising tool for universal screening of all HBsAg-positive persons.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"173 ","pages":"Article 105689"},"PeriodicalIF":8.8,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000519/pdfft?md5=106f59cdb8004e10ffbc5d378d171a49&pid=1-s2.0-S1386653224000519-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141034091","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":"Analytical and clinical evaluation of the cobas Epstein–Barr virus test at a tertiary care cancer hospital","authors":"Cindy Lee ,&nbsp;Younmin Lim ,&nbsp;Deborah Saintine ,&nbsp;N.Esther Babady","doi":"10.1016/j.jcv.2024.105680","DOIUrl":"https://doi.org/10.1016/j.jcv.2024.105680","url":null,"abstract":"<div><h3>Background</h3><p>Epstein–Barr Virus (EBV) viral loads in hematopoietic stem cell transplant (HSCT) recipients are typically monitored using quantitative molecular assays. The Cobas EBV test (Roche Molecular, Pleasanton, CA) has recently been FDA-cleared for the monitoring of EBV viral loads in plasma samples of transplant patients. In this study, we compared the viral loads obtained by a laboratory-developed test (EBV LDT) using Altona Analyte specific reagents (ASR) to those obtained on the Cobas EBV test.</p></div><div><h3>Methods</h3><p>The analytical performance of the assay was established using the EBV verification panel from Exact Diagnostics and the EBV ATCC strain B95-8. The clinical evaluation was performed using 343 plasma samples initially tested on the EBV LDT.</p></div><div><h3>Results</h3><p>The analytical sensitivity (&lt;18.8 IU/mL), precision (SD &lt; 0.17 log) and linear range (35.0 IU/mL to 1E + 08 IU/mL) of the Cobas EBV assay established by the manufacturers were confirmed. The strength of the qualitative agreement was substantial between the cobas EBV and the EBV LDT (85.6 %; <em>κ</em> = 0.71) and almost perfect when discordant results were resolved (96.4 %; <em>κ</em> = 0.93). The quantitative agreement was moderate (82.9 %; <em>κ</em> = 0.53) with the viral load obtained on the Cobas EBV test being lower across the linear range of the two tests (mean log difference of 1.0). While the absolute values of the viral loads were markedly different, the overall trends observed in patients with multiple consecutive results were similar between the two tests.</p></div><div><h3>Conclusions</h3><p>The Cobas EBV test provides an accurate and valid, in vitro diagnostic (IVD) option for monitoring of EBV viral loads in transplant patients and should provide an opportunity for increased standardization and commutability of tests results across laboratories.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"173 ","pages":"Article 105680"},"PeriodicalIF":8.8,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140893832","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":"Epidemiological and genetic characteristics of norovirus in Hangzhou, China, in the postepidemic era","authors":"Danlei Chen ,&nbsp;Qingyi Shao ,&nbsp;Xuanwen Ru ,&nbsp;Simiao Chen ,&nbsp;Dongqing Cheng ,&nbsp;Qing Ye","doi":"10.1016/j.jcv.2024.105679","DOIUrl":"https://doi.org/10.1016/j.jcv.2024.105679","url":null,"abstract":"<div><h3>Objective</h3><p>Norovirus (NoV) is an important human pathogen that can cause severe gastroenteritis in vulnerable populations. This study aimed to analyze the epidemiological and genetic characteristics of 2021–2023 NoV in Hangzhou, China.</p></div><div><h3>Methods</h3><p>This study enrolled patients aged 0–18 years who underwent NoV RNA detection in the hospital between January 2021 and October 2023 and analyzed the epidemiological characteristics of NoV. Polymerase chain reaction (PCR) was used to detect NoV RNA. Subtype classification and whole-genome sequencing were performed.</p></div><div><h3>Results</h3><p>There was a high prevalence of NoV infection in 2023, with NoV-positive samples accounting for 63.10 % of the total number of positive samples collected during the three-year period. The prevalence was abnormally high in summer, and the number of positive samples accounted for 48.20 % of the total positive samples for the whole year, which was much greater than the level in the same period in previous years (2023, 48.20% vs 2021, 13.66% vs 2022, 15.21 %). The GⅡ.4 subtype played a leading role, followed by increased mixed infection with GⅠ.5 and GⅡ.4. Whole-genome sequencing results suggested that GII.P16-GⅡ.4 had R297H and D372N key locus mutations. The evolutionary rate was 4.29 × 10⁻³ for the RdRp gene and 4.84 × 10⁻³ for the VP1 gene. The RdRp gene and VP1 gene of NoV GII.P16-GⅡ.4 have undergone rapid population evolution during the COVID-19 epidemic.</p></div><div><h3>Conclusion</h3><p>In the summer of 2023, an abnormally high incidence of NoV appeared in Hangzhou, China. The major epidemic strain GII.P16-GⅡ.4 showed a certain range of gene mutations and a fast evolutionary rate.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"172 ","pages":"Article 105679"},"PeriodicalIF":8.8,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140650589","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}