Journal of Clinical Virology最新文献

{"title":"Accurate quantification using the new RoboGene HDV RNA Quantification Kit 3.0: A European multicenter study","authors":"Evelyn Stelzl ,&nbsp;Annemarie Berger ,&nbsp;Sandra Ciesek ,&nbsp;Antonella Olivero ,&nbsp;Pietro Lampertico ,&nbsp;Annapaola Callegaro ,&nbsp;Sara Uceda Renteria ,&nbsp;Albert Heim ,&nbsp;Stephan W. Aberle ,&nbsp;David N. Springer ,&nbsp;Heiner Wedemeyer ,&nbsp;Birgit Bremer ,&nbsp;Lisa Sandmann ,&nbsp;André Reinhardt ,&nbsp;Beatrix Gey ,&nbsp;Christian Früchtel ,&nbsp;Harald H. Kessler","doi":"10.1016/j.jcv.2025.105828","DOIUrl":"10.1016/j.jcv.2025.105828","url":null,"abstract":"<div><h3>Background</h3><div>The management of chronic hepatitis delta requires reliable test systems for the detection and quantification of hepatitis delta virus (HDV) RNA. The aim of this study was to obtain comparable results between seven European laboratories using the new RoboGene HDV RNA Quantification Kit 3.0 (Roboscreen GmbH) in combination with different test systems consisting of different nucleic acid extraction and amplification/detection platforms.</div></div><div><h3>Methods</h3><div>Correction factors (CFs) were determined to harmonize HDV RNA concentrations using the 1st WHO International Standard for HDV RNA (WHO IS HDV RNA). Limits of detection (LODs) were determined using a dilution series of the WHO IS HDV RNA. Reference material was used for accuracy testing. In addition, 20 dilutions of plasma sample pools obtained from untreated chronic hepatitis D patients were analyzed.</div></div><div><h3>Results</h3><div>The CFs ranged from 14 to 10,000 depending on the test system used. The calculated CFs were used for subsequent quantification. LODs ranged from &lt;2.2 to &gt;575 IU/mL. When accuracy was determined, the two lowest HDV RNA concentrations were not detected by the test system with the lowest sensitivity. When dilutions of pooled samples were tested, 7 of 140 results were reported as negative from all centers.</div></div><div><h3>Conclusions</h3><div>Test-specific CFs must be determined to harmonize HDV RNA quantification. Appropriate platforms for HDV RNA extraction are essential to achieve an adequate detection limit. Both high sensitivity and accurate quantification are important for the accurate monitoring of the response to existing anti-HDV treatment and for clinical trials of novel anti-HDV drugs.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"179 ","pages":"Article 105828"},"PeriodicalIF":4.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144329890","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":"Prevalence of hepatitis B virus infection among pregnant women and cord blood hepatitis B surface antigen positive newborns in sub-Saharan Africa and South Asia","authors":"Carine Bokop ,&nbsp;Nisha Dhar ,&nbsp;Alane Izu ,&nbsp;Jayendrie Thaver-Kleitman ,&nbsp;Nishi Prabdial-sing ,&nbsp;Musa Mohammed Ali ,&nbsp;Godwin Akaba ,&nbsp;Hellen C. Barsosio ,&nbsp;James A. Berkley ,&nbsp;Manisha Madhai Beck ,&nbsp;Tolossa E. Chaka ,&nbsp;Clare L. Cutland ,&nbsp;Phurb Dorji ,&nbsp;Maksuda Islam ,&nbsp;Adama Mamby Keita ,&nbsp;Feleke Belachew Lema ,&nbsp;Nubwa Medugu ,&nbsp;Stella Mwakio ,&nbsp;Stephen Obaro ,&nbsp;Eyinade K. Olateju ,&nbsp;Shabir A. Madhi","doi":"10.1016/j.jcv.2025.105826","DOIUrl":"10.1016/j.jcv.2025.105826","url":null,"abstract":"<div><h3>Background</h3><div>Newborns infected with Hepatitis B Virus (HBV) are at risk of chronic liver disease and hepatocellular carcinoma.</div></div><div><h3>Objectives</h3><div>This study investigated the prevalence of HBV infection among pregnant women and cord blood Hepatitis B surface antigen (HBsAg) positivity of their newborns in Bangladesh, Bhutan, India, Ethiopia, Mozambique, Kenya, Nigeria, Mali, and South Africa.</div></div><div><h3>Study design</h3><div>Randomly selected paired maternal and cord blood samples (n = 101 each site) taken at delivery were tested for HBsAg and Hepatitis B extractable antigen (HBeAg) in the women using a chemiluminescent microparticle immunoassay. Similarly, cord blood sample of newborn was assessed for HBsAg reactivity. HBV DNA was quantified using the Xpert® HBV viral load assay, followed by genotyping.</div></div><div><h3>Results</h3><div>The overall prevalence of maternal HBsAg positivity was 5.5 % (95 %CI: 0.4 %–7.1 %; n = 50/909). HBsAg positivity was higher in African countries (7.3 %; 95 %CI: 5.4 %–9.6 %; n = 44/606) compared to South Asian countries (2.0 %; 95 %CI: 0.8 %–4.3 %; n = 6/303; p = 0.002). Relative to South Africa, there were higher odds of HBsAg sero-positivity in women from Mozambique ((aOR): 7.7, 95 %CI: 1.6 %–37.8 %) and Mali (aOR: 5.7; 95 %CI: 1.1 %–29.7 %). The rate of HBsAg positivity in cord blood of babies born to HBsAg positive women was 28.0 % (95 %CI: 17.1 %–42.3 %; n = 14/50), including 31.8 % (95 %CI: 19.5–47.4 %; n = 14/44) in African countries. No cord blood HBsAg positivity was observed in South Asia. Genotypic analysis revealed HBV genotypes A (41.7 %) and E (58.3 %) were pre-dominant.</div></div><div><h3>Conclusion</h3><div>The high rate of cord blood positivity (28.0 %) for HBsAg underscores the urgency of enhancing HBV prevention strategies to meet the World Health Organization’s target of a 90 % reduction in new HBV infections by 2030.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"179 ","pages":"Article 105826"},"PeriodicalIF":4.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144297647","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":"Evaluation of urinary hepatitis E virus antigen colloidal gold immunochromatographic assay in clinical diagnosis of hepatitis E virus infection","authors":"Conglin Zhao ,&nbsp;Shuai Tao ,&nbsp;Mengxin Lu ,&nbsp;Weixia Li ,&nbsp;Han Zhao ,&nbsp;Shuangshuang Sun ,&nbsp;Weijia Lin ,&nbsp;Chong Chen ,&nbsp;Qiang Li ,&nbsp;Yuxian Huang ,&nbsp;Liang Chen","doi":"10.1016/j.jcv.2025.105825","DOIUrl":"10.1016/j.jcv.2025.105825","url":null,"abstract":"<div><h3>Background</h3><div>Hepatitis E virus (HEV) is a significant public health concern worldwide. Current diagnostic methods for HEV infection have limitations in terms of accessibility and timeliness.</div></div><div><h3>Objective</h3><div>To assess the diagnostic performance of the Wantai urinary HEV antigen (Ag) colloidal gold immunochromatographic assay (GICA) in HEV infection.</div></div><div><h3>Methods</h3><div>This prospective study enrolled 150 patients with suspected acute hepatitis E and 50 healthy controls. Paired urine, fecal, and serum samples were collected during initial clinical evaluation. Serum and fecal HEV RNA levels were quantified via reverse transcription-quantitative polymerase chain reaction (RT-qPCR), with genotyping performed by nested RT-PCR. Serum anti-HEV IgM/IgG levels were measured by Enzyme-Linked Immunosorbent Assay (ELISA), and urinary HEV antigen was detected using GICA. Diagnostic accuracy metrics were calculated against the reference standard of HEV RNA detection.</div></div><div><h3>Results</h3><div>HEV RNA was detected in 58 % (87/150) of suspected cases. All successfully genotyped cases (69 %, 60/87) were HEV genotype 4. All healthy controls tested negative for HEV RNA and urinary HEV Ag.The urinary HEV Ag GICA showed 98.9 % sensitivity and 87.6 % specificity, with high concordance with RT-qPCR (Kappa = 0.85). Longitudinal follow-up revealed viral clearance and liver function normalization in most patients within 3–4 weeks post-symptom onset. 85.7 % of patients achieved urinary HEV Ag negative conversion within 6–7 weeks, while anti-HEV IgM remained positive in all patients at follow-up conclusion.</div></div><div><h3>Conclusion</h3><div>Urinary HEV Ag GICA demonstrates high diagnostic reliability for acute HEV infection, offering a practical non-invasive option for resource-limited settings.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"179 ","pages":"Article 105825"},"PeriodicalIF":4.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322006","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":"Management and outcomes of children hospitalised with COVID-19 including incidental and nosocomial infections in Australia 2020–2023: A national surveillance study","authors":"Elizabeth White ,&nbsp;Mehyar Khair Baik ,&nbsp;Syeda Farah Zahir ,&nbsp;Christopher C. Blyth ,&nbsp;Jeremy Carr ,&nbsp;Nigel W. Crawford ,&nbsp;Joshua R. Francis ,&nbsp;Helen S. Marshall ,&nbsp;Emma Carey ,&nbsp;Kristine Macartney ,&nbsp;Brendan McMullan ,&nbsp;Nicholas Wood ,&nbsp;Philip N. Britton ,&nbsp;Julia E. Clark ,&nbsp;on behalf of the PAEDS network","doi":"10.1016/j.jcv.2025.105824","DOIUrl":"10.1016/j.jcv.2025.105824","url":null,"abstract":"<div><h3>Background</h3><div>Management and outcomes of children hospitalised with acute SARS-CoV-2 infection may differ throughout the pandemic or with admission type (clinical COVID-19, incidental COVID-19 or nosocomial infection).</div></div><div><h3>Objectives</h3><div>Describe the severity, management and outcomes of hospitalised children with acute SARS-CoV-2 infection in Australia across the first 4 years of the pandemic and compare between admission types, SARS-CoV-2 variants, age groups and immune status.</div></div><div><h3>Study design</h3><div>A multi-centre prospective cohort study of 6009 children aged 0–16 years between January 2020 and June 2023.</div></div><div><h3>Results</h3><div>Most children (84.3 %) did not receive respiratory support, 33.4 % received antibiotics and 8 % were admitted to intensive care unit (ICU). Infants &lt;6 months old were more likely to be admitted with clinical COVID than older children (12–16 years). Older children were more likely to receive antibiotics (27.8 % vs 43.9 %), corticosteroids (11.3 % vs 34.1%) or ICU admission (5.2 % vs 13.5 %). Compared to immunocompetent children, the immunosuppressed (7.7 %) were more likely to have nosocomial infection (9.5 % vs 3.9 %), receive antibiotics (57 % vs 25 %) or antivirals (18 % vs 4.4 %), but less likely to require respiratory support (93.4 % vs 83.8 %) or ICU admission (3.5 % vs 8 %). Children with nosocomial SARS-CoV-2 infection had higher rates of invasive ventilation (8 %) and ICU admission (21 %) compared to those with clinical (2.1 % and 7.1 % respectively) or incidental COVID-19 (4.8 % and 9.1 % respectively).</div></div><div><h3>Conclusions</h3><div>Acute COVID-19 generally caused mild disease in hospitalised children, with management and outcomes differing by age and admission type. Similar outcomes were observed across the pandemic. Nosocomial SARS-CoV-2 infection was associated with more severe disease.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"179 ","pages":"Article 105824"},"PeriodicalIF":4.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144307294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative evaluation of STANDARD™ M10 Flu/RSV/SARS-CoV-2 and Savanna® Respiratory Viral Panel-4 assays for the rapid molecular diagnosis of influenza A/B virus, respiratory syncytial virus and SARS-CoV-2","authors":"Juulia Suominen,&nbsp;Raisa Loginov,&nbsp;Hannimari Kallio-Kokko","doi":"10.1016/j.jcv.2025.105827","DOIUrl":"10.1016/j.jcv.2025.105827","url":null,"abstract":"<div><h3>Background</h3><div>The occurrence of respiratory infections caused by seasonal viruses influenza A/B, RSV and SARS-CoV-2 has increased the demand for rapid diagnostic assays. Comparative performance data of such assays is required.</div></div><div><h3>Methods</h3><div>In this retrospective study, clinical samples were tested with the STANDARD™ M10 Flu/RSV/SARS-CoV-2 test and the novel Savanna® Respiratory Viral Panel-4 tests, with Xpert® Xpress SARS-CoV-2/Flu/RSV as the reference. All three are RT-PCR tests suitable for point-of-care testing. Discordant results on the Savanna assay were retested with a new research-use-only protocol. Serial dilution testing for all three was performed with an external control.</div></div><div><h3>Results</h3><div>A total of 141 clinical samples, including 106 specimens positive for at least one virus, were analyzed. The M10 assay showed sensitivities of 100 %, 95.7 %, 97.1 % and 97.0 % for influenza A, B, RSV and SARS-CoV-2, respectively. The Savanna assay showed sensitivities of 92.6 %, 95.7 %, 100 % and 90.9 %. Both assays exhibited high specificity (≥99 %), except for the Savanna assay’s lower specificity for RSV (94.2 %) and SARS-CoV-2 (94.3 %). Savanna had a higher retest rate (5.0 %), while M10 produced only conclusive results. Serial dilution testing showed that Xpert detected three viruses more effectively than the other assays.</div></div><div><h3>Conclusion</h3><div>Both M10 and Savanna performed well for influenza A/B, but M10 was superior for RSV and SARS-CoV-2 due to false positives with Savanna. The new Savanna protocol showed promise, but further studies are required to confirm these findings. Xpert assay was the most sensitive for detecting low viral amounts.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"179 ","pages":"Article 105827"},"PeriodicalIF":4.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144271575","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":"Prevalence of human adenovirus in children with acute gastroenteritis in the New Vaccine Surveillance Network (NVSN) from 2016 to 2019","authors":"Amy J. Kinzler ,&nbsp;Mary E. Wikswo ,&nbsp;G.K. Balasubramani ,&nbsp;Helen Eleni Aslanidou D’Agostino ,&nbsp;Theresa Sax ,&nbsp;Klancie Dauer ,&nbsp;Geoffrey A. Weinberg ,&nbsp;Peter Szilyagi ,&nbsp;Leila C. Sahni ,&nbsp;Julie A. Boom ,&nbsp;Jennifer E. Schuster ,&nbsp;Rangaraj Selvarajan ,&nbsp;Christopher J. Harrison ,&nbsp;Mary A. Staat ,&nbsp;Daniel C. Payne ,&nbsp;Natasha B. Halasa ,&nbsp;Eileen J. Klein ,&nbsp;Janet A. Englund ,&nbsp;Judith M. Martin ,&nbsp;Robert Hickey ,&nbsp;John V. Williams","doi":"10.1016/j.jcv.2025.105822","DOIUrl":"10.1016/j.jcv.2025.105822","url":null,"abstract":"<div><h3>Background</h3><div>Acute gastroenteritis (AGE) is a leading cause of pediatric morbidity and mortality. However, the AGE burden from human adenoviruses (HAdV) is not fully defined.</div></div><div><h3>Objective</h3><div>To determine the prevalence and characteristics associated with HAdV in U.S. children.</div></div><div><h3>Study design</h3><div>We enrolled AGE case-patients &lt;18 years of age in inpatient and emergency department (ED) settings and healthy controls &lt;11 years of age between December 2016 and November 2019 at seven pediatric medical centers. Demographic and clinical data and stools were prospectively collected. Stools were tested for HAdV F40/41 using multiplex molecular panels. A subset of 120 HAdV-positive samples was genotyped.</div></div><div><h3>Results</h3><div>HAdV was detected in 168 (8 %) of 2229 ED patients, 164 (8 %) of 2151 inpatients, and 23 (1 %) of 2090 healthy controls. AGE case-patients positive for HAdV were more likely to be &lt;3 years of age and more likely to report diarrhea (86 % vs 67 %) and dehydration (43 % vs 31 %) than HAdV-negative case-patients (p &lt; 0.0001, all comparisons). Age did not differ significantly between HAdV-positive and negative controls. HAdV-positive AGE case-patients were less likely to have acute respiratory symptoms than HAdV-negative case-patients (8 % vs 18 %, p &lt; 0.0001). The most frequently detected HAdV genotype was F41 (n = 106, 88 %). Other potential pathogens were detected in 36 % of HAdV-positive AGE case-patients and 43 % of controls; <em>Clostridioides difficile</em> was most common.</div></div><div><h3>Conclusions</h3><div>HAdV accounted for 8 % of medically attended AGE in both inpatient and ED settings in the U.S., primarily in young children. The majority of cases were type F41, which may inform future vaccine development.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"179 ","pages":"Article 105822"},"PeriodicalIF":4.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144243457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical and sociodemographic correlates of emergent or evolving HIV drug resistance in low viral load specimens in British Columbia, Canada","authors":"Hanwei Sudderuddin ,&nbsp;Charlotte Johanna Beelen ,&nbsp;Jenny Li ,&nbsp;Wendy Zhang ,&nbsp;Melanie C.M. Murray ,&nbsp;Viviane D. Lima ,&nbsp;Julio S.G. Montaner ,&nbsp;Chanson J. Brumme","doi":"10.1016/j.jcv.2025.105807","DOIUrl":"10.1016/j.jcv.2025.105807","url":null,"abstract":"<div><h3>Background/methods</h3><div>Treatment guidelines recommend genotypic HIV drug resistance testing (DRT) at virologic failure, typically for plasma viral loads (pVL) &gt; 1000 HIV RNA c/mL. In some settings, DRT can be performed on low viral load (LVL) samples (pVL of 50–250 c/mL); however, such testing is resource-intensive and its clinical benefit is unclear. Therefore, we investigated the frequency and factors associated with emergent resistance in LVL samples using a comprehensive, provincial database of HIV Protease-Reverse Transcriptase and Integrase sequences.</div></div><div><h3>Results</h3><div>A total of 43,979 Protease-RT DRTs were performed in British Columbia between 1999 and 2022, of which 2970 (6.8 %) were on LVL samples. Testing was successful for 1575 (53.0 %) LVL samples compared to 81.4 % and 94.4 % of samples with pVL 250–999 and pVL ≥ 1000 c/mL, respectively (p &lt; 0.001). Compared to prior genotypes collected from samples with pVL &gt; 250 c/mL, a total of 104 (7.3 %) cases of new or evolving drug resistance were identified from 1423 LVL DRTs. Of these, 49.5 %, 42.9 % and 22.9 % exhibited new Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease resistance, respectively. Of 9309 Integrase DRTs performed between 2008 and 2022, only 4 (1.2 %) cases of new or evolving integrase resistance were observed. Multivariable analyses identified clinical/sociodemographic factors significantly associated with emergent resistance, including time elapsed between DRTs, historic cumulative resistance and NNRTI-based antiretroviral therapy.</div></div><div><h3>Conclusions</h3><div>Emergent or evolving resistance is identified infrequently in low viral load specimens. Given its resource-intensive nature, resistance testing of low viral load specimens may not be generally warranted.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"178 ","pages":"Article 105807"},"PeriodicalIF":4.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144189834","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":"Coordinated implementation of a conventional PCR assay to detect all Ebola and Marburg virus species in a European laboratory network","authors":"K.C. Heimsch ,&nbsp;T. Bleicker ,&nbsp;T.D. Best ,&nbsp;L.D. Presser ,&nbsp;R. Molenkamp ,&nbsp;A.J. Jääskeläinen ,&nbsp;A. Milewska ,&nbsp;J. Šmahelová ,&nbsp;C. Baronti ,&nbsp;S. Pappa ,&nbsp;I. Tabain ,&nbsp;R. Cordeiro ,&nbsp;G. Marsili ,&nbsp;K. Huik ,&nbsp;V. Pinho dos Reis ,&nbsp;L. Barzon ,&nbsp;P. Maes ,&nbsp;C. Drosten ,&nbsp;V.M. Corman","doi":"10.1016/j.jcv.2025.105808","DOIUrl":"10.1016/j.jcv.2025.105808","url":null,"abstract":"<div><h3>Background</h3><div>Filoviruses, including Ebola and Marburg viruses, cause severe hemorrhagic fever in humans and primates. These viruses pose significant threats to public health, making rapid and sensitive detection critical for controlling outbreaks. We developed and validated a hemi-nested generic PanFilo assay to detect all Ebola virus species, Marburg viruses, and recently discovered bat filoviruses. This assay was deployed to 15 European laboratories and evaluated through testing of eight non-infectious samples.</div></div><div><h3>Objectives</h3><div>Laboratories were asked to determine the detection limit of positive controls and test all samples using the assay provided. The deployed assay enables direct Nanopore sequencing of PCR products, by using tagged primers during the second round of PCR. Sequencing of the samples was carried out on a voluntary basis.</div></div><div><h3>Results</h3><div>Multicenter validation revealed a 95 % limit of detection of 5309 RNA copies/µL for Ebola, 10,273 copies/µL for Marburg, and 2145 copies/µL for Mengla virus. In an implementation quality assessment, 93.3 % (84/90) of samples containing filovirus RNA were correctly identified and 100 % (30/30) of filovirus-negative samples were correctly identified. Thirteen laboratories sequenced PCR products, with nine identifying all positive samples correctly.</div></div><div><h3>Conclusion</h3><div>The assay enables rapid and reliable detection of filoviruses, with sequencing capabilities for identifying both known and novel variants. This assay might be used for detection during the initial phase of an emerging filovirus outbreak, before a specific assay has been developed. However, our distribution across 15 laboratories revealed variability challenges due to reagents, human performance, and sequencing capacity, emphasizing the need for more training and standardization.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"178 ","pages":"Article 105808"},"PeriodicalIF":4.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144185662","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":"Retraction notice to “Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial” [J. Clin. Virol. 155C (2022) 105248]","authors":"Damian Balmforth ,&nbsp;James A. Swales ,&nbsp;Laurence Silpa ,&nbsp;Alan Dunton ,&nbsp;Kay E. Davies ,&nbsp;Stephen G. Davies ,&nbsp;Archana Kamath ,&nbsp;Jayanti Gupta ,&nbsp;Sandeep Gupta ,&nbsp;M. Abid Masood ,&nbsp;Áine McKnight ,&nbsp;Doug Rees ,&nbsp;Angela J. Russell ,&nbsp;Manu Jaggi ,&nbsp;Rakesh Uppal","doi":"10.1016/j.jcv.2025.105782","DOIUrl":"10.1016/j.jcv.2025.105782","url":null,"abstract":"","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"178 ","pages":"Article 105782"},"PeriodicalIF":4.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078130","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":"Post-mortem study of endemic human coronaviruses (HCoV-NL63, OC43, 229E and HKU-1) in deaths of children under five in low- and middle-income countries: Findings from the Child Health and Mortality Prevention Surveillance (CHAMPS) study","authors":"Vicky Baillie ,&nbsp;Ziyaad Dangor ,&nbsp;Dianna M. Blau ,&nbsp;Sana Mahtab ,&nbsp;Jeanie du Toit ,&nbsp;Nega Assefa ,&nbsp;Joseph Oundo ,&nbsp;Zelalem Teklemariam Kidanemariam ,&nbsp;J. Anthony G. Scott ,&nbsp;Soter Ameh ,&nbsp;Ikechukwu Udo Ogbuanu ,&nbsp;Julius Ojulong ,&nbsp;James Bunn ,&nbsp;Karen L. Kotloff ,&nbsp;Samba O. Sow ,&nbsp;Milagritos D. Tapia ,&nbsp;Adama Mamby Keita ,&nbsp;Marcelino Garrine ,&nbsp;Inacio Mandomando ,&nbsp;Rosauro Varo ,&nbsp;Shabir A. Madhi","doi":"10.1016/j.jcv.2025.105804","DOIUrl":"10.1016/j.jcv.2025.105804","url":null,"abstract":"<div><h3>Background</h3><div>Endemic human coronaviruses (HCoV-229E, HKU1, NL63, and OC43) are common causes of mild or asymptomatic respiratory infections in children but are considered rare causes of death.</div></div><div><h3>Methods</h3><div>We evaluated pediatric deaths from January 2017 through December 2022. A panel of experts determined the cause of death (CoD) by reviewing available data, including pathological and molecular findings from minimally invasive tissue sampling (lung tissues, blood, CSF, and nasopharyngeal swabs), clinical records, and verbal autopsies.</div></div><div><h3>Results</h3><div>Endemic HCoV were detected in the respiratory samples of 3 % (n = 86/3357) of enrolled decedents: 1 % (n = 12/2043) of neonates, 5 % (n = 35/681) of infants and 6 % (n = 39/633) of children deaths. However, HCoVs were attributed as the CoD in only two cases — both involving young infants with underlying birth defects and severe wasting, who succumbed to polymicrobial hospital-acquired infections involving <em>HCoV-OC43</em>, <em>Klebsiella pneumoniae</em>, and <em>Acinetobacter baumannii</em>. Amongst the remaining 84 decedents in whom an HCoV was detected, 82 % (n = 69/84; median Ct of 25.34; range: 15.28–36.17) were deaths attributed to other infections, including 54 % (n = 32/69; median Ct of 23.86; range: 15.28–35.2) with lower respiratory infections determined to be the CoD. The bulk of these deaths (96 %, n = 66/69) were attributed to other pathogens – <em>Plasmodium falciparum</em> (27 %, n = 19/69), <em>K. pneumoniae</em> (23 %, n = 16/69), <em>Streptococcus pneumoniae</em> (20 %, n = 14/69), <em>Escherichia coli</em> (16 %, n = 11/69) and Cytomegalovirus (10 %, n = 7/69).</div></div><div><h3>Conclusion</h3><div>Although endemic HCoV was identified in children who died of respiratory infections, it was rarely attributed to being in the CoD. Nevertheless, further research is warranted to explore the potential role of HCoVs in LRTI pathogenesis and their impact on facilitating more pathogenic infections.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"178 ","pages":"Article 105804"},"PeriodicalIF":4.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144189833","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}