Pub Date : 2026-04-01Epub Date: 2026-01-24DOI: 10.1016/j.jcv.2026.105921
Xiaoqin Yuan , Xinyi Xiang , Hongqian Xu , Wencen Lu , JinJing Zhang , Zhili Hu , Shiying Li , Li Zhou
Background
Complete virological response (CVR) is the primary goal of nucleos(t)ide analogues (NAs) therapy for chronic hepatitis B (CHB) patients. The objective of this study was to develop and validate a machine learning (ML) model to predict CVR in CHB patients receiving first-line NAs.
Methods
We retrospectively analyzed 2394 CHB patients treated with first-line NAs, randomly divided into a training set and an internal validation set at a 7:3 ratio. Key predictors were identified through univariate analysis, followed by Lasso, SVM-RFE, and Boruta feature selection algorithms. Seven machine learning models were developed and compared, interpreting results with SHapley Additive exPlanations (SHAP) analysis.
Results
A total of 2394 CHB patients were included, among whom 1597 (66.7 %) achieved CVR. Baseline HBV DNA, HBeAg, DBIL, Age, Cirrhosis, ALT, PLT, FIB4, and HBsAg were identified as significant influencing factors. Among the seven ML methods, the XGBoost model demonstrated the best performance with an AUC of 0.864 in the training set and 0.823 in the validation set. SHAP analysis identified baseline HBV DNA and HBeAg status as the top two predictors. This web-based calculator is designed to help predict the probability of achieving CVR at 48 weeks in CHB patients receiving first-line NAs treatment (http://yuanxq.shinyapps.io/CVR-prediction-app).
Conclusion
We developed and validated an interpretable machine learning model to predict CVR at 48 weeks in CHB patients treated with first-line NAs.
{"title":"A machine learning model for predicting complete virological response in chronic hepatitis B patients receiving first-line nucleos(t)ide analogues therapy","authors":"Xiaoqin Yuan , Xinyi Xiang , Hongqian Xu , Wencen Lu , JinJing Zhang , Zhili Hu , Shiying Li , Li Zhou","doi":"10.1016/j.jcv.2026.105921","DOIUrl":"10.1016/j.jcv.2026.105921","url":null,"abstract":"<div><h3>Background</h3><div>Complete virological response (CVR) is the primary goal of nucleos(t)ide analogues (NAs) therapy for chronic hepatitis B (CHB) patients. The objective of this study was to develop and validate a machine learning (ML) model to predict CVR in CHB patients receiving first-line NAs.</div></div><div><h3>Methods</h3><div>We retrospectively analyzed 2394 CHB patients treated with first-line NAs, randomly divided into a training set and an internal validation set at a 7:3 ratio. Key predictors were identified through univariate analysis, followed by Lasso, SVM-RFE, and Boruta feature selection algorithms. Seven machine learning models were developed and compared, interpreting results with SHapley Additive exPlanations (SHAP) analysis.</div></div><div><h3>Results</h3><div>A total of 2394 CHB patients were included, among whom 1597 (66.7 %) achieved CVR. Baseline HBV DNA, HBeAg, DBIL, Age, Cirrhosis, ALT, PLT, FIB4, and HBsAg were identified as significant influencing factors. Among the seven ML methods, the XGBoost model demonstrated the best performance with an AUC of 0.864 in the training set and 0.823 in the validation set. SHAP analysis identified baseline HBV DNA and HBeAg status as the top two predictors. This web-based calculator is designed to help predict the probability of achieving CVR at 48 weeks in CHB patients receiving first-line NAs treatment (<span><span>http://yuanxq.shinyapps.io/CVR-prediction-app</span><svg><path></path></svg></span>).</div></div><div><h3>Conclusion</h3><div>We developed and validated an interpretable machine learning model to predict CVR at 48 weeks in CHB patients treated with first-line NAs.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"183 ","pages":"Article 105921"},"PeriodicalIF":3.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146113348","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}
Pub Date : 2026-04-01Epub Date: 2026-02-02DOI: 10.1016/j.jcv.2026.105924
Susanne Pfefferle, Dominik Nörz, Katja Giersch, Moritz Grunwald, Hui Ting Tang, Lisa Sophie Pflüger, Marc Lütgehetmann
Background
Continuous viral evolution is likely to cause a loss of performance or failure of existing diagnostic assays. Here, we delineate the adaptation and validation of an operational laboratory developed (LDT) multiplex RT-qPCR for simultaneous detection of SARS-CoV-2, influenza A/B (FluA/B) and respiratory syncytial virus (RSV) on a high-throughput, fully automated platform. Furthermore, we explore the integration of an alternative SARS-CoV-2 target to enhance assay robustness
Methods
An adaption of the operational assay (PMID:38820916) was performed and a novel SARS-CoV-2 target (macrodomain, Mac1) was implemented. Analytical performance of the adapted assay was evaluated using digital-PCR based standards or international reference material and clinical performance was assessed on clinical samples with a CE-IVD comparator assay.
Results
Analytical sensitivity (lower limit of detection (LoD)) was 70.9 IU/ml for SARS-CoV-2, and 112–474, 919 and 1720 cp/ml for influenza A, influenza B and RSV, respectively, with linear ranges of 26.3–36.4 ct (SARS-CoV-2), 26.8–37.7 ct (FluA), 28.5–37.9 (FluB) and 25.6–38.2 (RSV). Clinical performance evaluation confirmed improved performance (e.g. FluA/B detection −1.6/-4.81 ct) and comparable performance to the CE-IVD assay (excellent correlation of the SARS-CoV-2 assays, more effective detection of influenza B). Overall, positive/negative agreement was 100 %/93 % (SARS-CoV-2), and 100 %/100 % (FluA/B, RSV).
Conclusion
The adapted LDT assay as a focused syndromic assay provides reliable detection of major respiratory viruses on a high-throughput platform. The strategic targeting of conserved genomic regions ensures diagnostic resilience, while automated integration facilitates scalable laboratory operations. This approach facilitates robust pathogen surveillance and expedites clinical decision-making during periods of co-circulation and epidemic surge.
{"title":"Refined fully automated RT-qPCR assay for simultaneous detection of SARS-CoV-2, Influenza A/B, and RSV with target optimization for improved variant resilience","authors":"Susanne Pfefferle, Dominik Nörz, Katja Giersch, Moritz Grunwald, Hui Ting Tang, Lisa Sophie Pflüger, Marc Lütgehetmann","doi":"10.1016/j.jcv.2026.105924","DOIUrl":"10.1016/j.jcv.2026.105924","url":null,"abstract":"<div><h3>Background</h3><div>Continuous viral evolution is likely to cause a loss of performance or failure of existing diagnostic assays. Here, we delineate the adaptation and validation of an operational laboratory developed (LDT) multiplex RT-qPCR for simultaneous detection of SARS-CoV-2, influenza A/B (FluA/B) and respiratory syncytial virus (RSV) on a high-throughput, fully automated platform. Furthermore, we explore the integration of an alternative SARS-CoV-2 target to enhance assay robustness</div></div><div><h3>Methods</h3><div>An adaption of the operational assay (PMID:38820916) was performed and a novel SARS-CoV-2 target (macrodomain, Mac1) was implemented. Analytical performance of the adapted assay was evaluated using digital-PCR based standards or international reference material and clinical performance was assessed on clinical samples with a CE-IVD comparator assay.</div></div><div><h3>Results</h3><div>Analytical sensitivity (lower limit of detection (LoD)) was 70.9 IU/ml for SARS-CoV-2, and 112–474, 919 and 1720 cp/ml for influenza A, influenza B and RSV, respectively, with linear ranges of 26.3–36.4 ct (SARS-CoV-2), 26.8–37.7 ct (FluA), 28.5–37.9 (FluB) and 25.6–38.2 (RSV). Clinical performance evaluation confirmed improved performance (e.g. FluA/B detection −1.6/-4.81 ct) and comparable performance to the CE-IVD assay (excellent correlation of the SARS-CoV-2 assays, more effective detection of influenza B). Overall, positive/negative agreement was 100 %/93 % (SARS-CoV-2), and 100 %/100 % (FluA/B, RSV).</div></div><div><h3>Conclusion</h3><div>The adapted LDT assay as a focused syndromic assay provides reliable detection of major respiratory viruses on a high-throughput platform. The strategic targeting of conserved genomic regions ensures diagnostic resilience, while automated integration facilitates scalable laboratory operations. This approach facilitates robust pathogen surveillance and expedites clinical decision-making during periods of co-circulation and epidemic surge.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"183 ","pages":"Article 105924"},"PeriodicalIF":3.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146125055","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}
Pub Date : 2026-04-01Epub Date: 2026-01-27DOI: 10.1016/j.jcv.2026.105923
Huanyu Wang , Kathy Everhart , Sophonie J. Oyeniran , Amy L. Leber
Background
La Crosse virus (LACV), a member of family Peribunyaviridae, genus Orthobunyavirus, is the leading cause of neuroinvasive arboviral infection in children in the United States. Diagnosis relies on detecting specific antibodies (IgG or IgM), a 4-fold titer rise or seroconversion, in patients with compatible presentations. NAAT used for LACV detection has largely been limited to mosquito, animal models or postmortem brain tissue. There is a lack of data on the performance of NAATs in clinical specimens from living patients.
Methods
Children who had positive arbovirus serology tests and a diagnosis of LACV encephalitis were identified. Remnant specimens including plasma, serum, CSF, throat swab (THT) or nasopharyngeal sample (NP) submitted to the laboratory for other diagnostic testing were retrieved and tested with LACV-PCR. Medical records were reviewed for demographics, presenting symptoms and test results.
Results
From June 2015 to October 2021, 61 patients had remnant specimens available for LACV-PCR and were included in this study. A total of 179 clinical specimens from these patients were tested, including 64 sera, 31 plasma, 33 CSF, 23 THT and 28 NP. Ten (5.3 %) samples collected from 8 (13.1 %) unique patients were positive for LACV RNA. The positive rates were 3.2 %, 0, 6.5 %, 3.5 % and 21.7 % for sera, plasma, CSF, NP and THT respectively.
Conclusion
There is limited utility of NAATs for diagnosis of LACV infection. NAATs may be useful in cases with delayed seroconversion or in immunocompromised individuals.
{"title":"Detection of La Crosse virus RNA in clinical specimens obtained from children with La Crosse infection","authors":"Huanyu Wang , Kathy Everhart , Sophonie J. Oyeniran , Amy L. Leber","doi":"10.1016/j.jcv.2026.105923","DOIUrl":"10.1016/j.jcv.2026.105923","url":null,"abstract":"<div><h3>Background</h3><div>La Crosse virus (LACV), a member of family <em>Peribunyaviridae</em>, genus <em>Orthobunyavirus</em>, is the leading cause of neuroinvasive arboviral infection in children in the United States. Diagnosis relies on detecting specific antibodies (IgG or IgM), a 4-fold titer rise or seroconversion, in patients with compatible presentations. NAAT used for LACV detection has largely been limited to mosquito, animal models or postmortem brain tissue. There is a lack of data on the performance of NAATs in clinical specimens from living patients.</div></div><div><h3>Methods</h3><div>Children who had positive arbovirus serology tests and a diagnosis of LACV encephalitis were identified. Remnant specimens including plasma, serum, CSF, throat swab (THT) or nasopharyngeal sample (NP) submitted to the laboratory for other diagnostic testing were retrieved and tested with LACV-PCR. Medical records were reviewed for demographics, presenting symptoms and test results.</div></div><div><h3>Results</h3><div>From June 2015 to October 2021, 61 patients had remnant specimens available for LACV-PCR and were included in this study. A total of 179 clinical specimens from these patients were tested, including 64 sera, 31 plasma, 33 CSF, 23 THT and 28 NP. Ten (5.3 %) samples collected from 8 (13.1 %) unique patients were positive for LACV RNA. The positive rates were 3.2 %, 0, 6.5 %, 3.5 % and 21.7 % for sera, plasma, CSF, NP and THT respectively.</div></div><div><h3>Conclusion</h3><div>There is limited utility of NAATs for diagnosis of LACV infection. NAATs may be useful in cases with delayed seroconversion or in immunocompromised individuals.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"183 ","pages":"Article 105923"},"PeriodicalIF":3.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146070914","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}
On February the 7th 2024, BioFire® alerted users to a risk of false-positive norovirus results with the BioFire® FilmArray® Gastrointestinal Panel (BF-GIP) and recommended confirmatory testing.
Objectives
To assess the reliability of BF-GIP norovirus-positive results in children and develop a decision algorithm for managing potential false positives.
Study design
Between January and June 2025, all BF-GIP norovirus-positive samples were re-tested the same day using the GeneXpert® Norovirus assay (Cepheid®). BF-GIP cycle thresholds (Ct) values and melting curves were analyzed.
Results
Of the 1007 BF-GIP performed, 131 were norovirus-positive and 127 were retested by the GeneXpert® Norovirus assay. Overall, 31.5 % (40/127) were discordant. Atypical melting curves (22/40, 55 %), high Ct values (> 25) or “N/A” results were strongly associated with discordance, while Ct ≤ 20 were highly predictive of concordance. Based on these metrics, 58 % of BF-GIP norovirus-positive results could be confidently confirmed or rejected without additional testing.
Conclusion
False norovirus-positive results by the BF-GIP are common. An algorithm integrating BF-GIP Ct values and melting curve analysis can reduce unnecessary retesting, streamline laboratory workflow and support accurate diagnosis in pediatric settings.
{"title":"Practical management of positive norovirus results from FilmArray® GI panel","authors":"Noémie Rybak , Philippe Bidet , Yasmine Benhadid-Brahmi , Aurélie Cointe , Hosam Dawoud , Maud Gits-Muselli , Audrey Baron , Stéphane Bonacorsi , André Birgy","doi":"10.1016/j.jcv.2026.105922","DOIUrl":"10.1016/j.jcv.2026.105922","url":null,"abstract":"<div><h3>Background</h3><div>On February the 7th 2024, BioFire® alerted users to a risk of false-positive norovirus results with the BioFire® FilmArray® Gastrointestinal Panel (BF-GIP) and recommended confirmatory testing.</div></div><div><h3>Objectives</h3><div>To assess the reliability of BF-GIP norovirus-positive results in children and develop a decision algorithm for managing potential false positives.</div></div><div><h3>Study design</h3><div>Between January and June 2025, all BF-GIP norovirus-positive samples were re-tested the same day using the GeneXpert® Norovirus assay (Cepheid®). BF-GIP cycle thresholds (Ct) values and melting curves were analyzed.</div></div><div><h3>Results</h3><div>Of the 1007 BF-GIP performed, 131 were norovirus-positive and 127 were retested by the GeneXpert® Norovirus assay. Overall, 31.5 % (40/127) were discordant. Atypical melting curves (22/40, 55 %), high Ct values (> 25) or “N/A” results were strongly associated with discordance, while Ct ≤ 20 were highly predictive of concordance. Based on these metrics, 58 % of BF-GIP norovirus-positive results could be confidently confirmed or rejected without additional testing.</div></div><div><h3>Conclusion</h3><div>False norovirus-positive results by the BF-GIP are common. An algorithm integrating BF-GIP Ct values and melting curve analysis can reduce unnecessary retesting, streamline laboratory workflow and support accurate diagnosis in pediatric settings.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"183 ","pages":"Article 105922"},"PeriodicalIF":3.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146076849","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}
Pub Date : 2026-03-14DOI: 10.1016/j.jcv.2026.105931
Phuong-Vi Nguyen, Jayden Kimbro, Kumail Ahmed, Dhruv Miglani, Sarah Hernandez, David R Myers, Najeeha Talat Iqbal, Jesse J Waggoner
Background: Nipah virus (NiV) is a highly pathogenic, zoonotic paramyxovirus with significant public health implications due to high associated mortality and potential for human-to-human transmission. Current diagnostic testing options for NiV are limited and require extensive laboratory infrastructure.
Objective: Develop a field-deployable testing workflow for timely NiV detection.
Study design: A NiV real-time RT-PCR (rRT-PCR) was designed for a highly conserved region of the nucleocapsid gene and tested with RNA from Bangladesh and Malaysia NiV strains. The NiV rRT-PCR was evaluated on Rotor-Gene Q and Palm PCR S1e thermocyclers following instrument free RNA extraction (Extract & Store).
Results: Initial analytical evaluation, on a Rotor-Gene Q, demonstrated dynamic amplification and a limit of detection (LoD) of 3.7-4.2 copies/µL without amplification of related paramyxoviruses. The assay was adapted for the portable, battery-powered, self-contained Palm PCR S1e thermocycler, and exhibited linear detection with a LoD of 30.7 copies/µL. RNA extraction from contrived whole blood and pharyngeal swabs using the Extract & Store workflow yielded comparable results to automated extraction on a KingFisher Apex instrument. The entire assay, including extracted and stabilized RNA controls from BSL-1 strains, was successfully transferred to Aga Khan University with ambient temperature shipping and yielded similar performance.
Conclusions: The combination of Extract & Store and the Palm PCR S1e device offers a viable solution for field-based molecular detection of NiV. While limitations were noted for reaction setup on the Palm PCR, this presents a flexible and accessible workflow for rapid, portable detection of high-consequence pathogens in resource-constrained settings.
{"title":"Nipah virus molecular detection from whole blood and respiratory swabs in a rapid field-ready protocol.","authors":"Phuong-Vi Nguyen, Jayden Kimbro, Kumail Ahmed, Dhruv Miglani, Sarah Hernandez, David R Myers, Najeeha Talat Iqbal, Jesse J Waggoner","doi":"10.1016/j.jcv.2026.105931","DOIUrl":"https://doi.org/10.1016/j.jcv.2026.105931","url":null,"abstract":"<p><strong>Background: </strong>Nipah virus (NiV) is a highly pathogenic, zoonotic paramyxovirus with significant public health implications due to high associated mortality and potential for human-to-human transmission. Current diagnostic testing options for NiV are limited and require extensive laboratory infrastructure.</p><p><strong>Objective: </strong>Develop a field-deployable testing workflow for timely NiV detection.</p><p><strong>Study design: </strong>A NiV real-time RT-PCR (rRT-PCR) was designed for a highly conserved region of the nucleocapsid gene and tested with RNA from Bangladesh and Malaysia NiV strains. The NiV rRT-PCR was evaluated on Rotor-Gene Q and Palm PCR S1e thermocyclers following instrument free RNA extraction (Extract & Store).</p><p><strong>Results: </strong>Initial analytical evaluation, on a Rotor-Gene Q, demonstrated dynamic amplification and a limit of detection (LoD) of 3.7-4.2 copies/µL without amplification of related paramyxoviruses. The assay was adapted for the portable, battery-powered, self-contained Palm PCR S1e thermocycler, and exhibited linear detection with a LoD of 30.7 copies/µL. RNA extraction from contrived whole blood and pharyngeal swabs using the Extract & Store workflow yielded comparable results to automated extraction on a KingFisher Apex instrument. The entire assay, including extracted and stabilized RNA controls from BSL-1 strains, was successfully transferred to Aga Khan University with ambient temperature shipping and yielded similar performance.</p><p><strong>Conclusions: </strong>The combination of Extract & Store and the Palm PCR S1e device offers a viable solution for field-based molecular detection of NiV. While limitations were noted for reaction setup on the Palm PCR, this presents a flexible and accessible workflow for rapid, portable detection of high-consequence pathogens in resource-constrained settings.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"184 ","pages":"105931"},"PeriodicalIF":3.4,"publicationDate":"2026-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147499340","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}
Pub Date : 2026-02-01Epub Date: 2025-11-17DOI: 10.1016/j.jcv.2025.105889
Ana I. Cubas Atienzar , Christopher T. Williams , Yasemin Cosgun , Fatma Gonca Arslan , Hakan Hedef , Ilkay Bozkurt , Kevin S. Richards , Sian Summers , James Pitman , Shaun Ainsworth , Gino Miele , Cristina Leggio , William Nicholas , Hilary Bower , Benedict Gannon , Tom E. Fletcher , Gulay Korukluoglu , Thomas Edwards
Introduction
Crimean-Congo haemorrhagic fever (CCHF) is a viral haemorrhagic fever classed by the World Health Organization as a priority disease due to the lack of countermeasures. A point-of-care (POC) diagnostic test for rapid detection of positive cases to expedite patient management is not currently available but urgently needed.
Methods
We have developed an RT-qPCR assay to be used with the commercially available POC Genedrive® PCR platform enabling viral detection in serum with minimal sample preparation. The sensitivity and specificity of the novel assay in the Genedrive® was evaluated against the RealStar® CCHFV RT-qPCR Kit (Altona Diagnostics, Germany).
Results
The sensitivity and specificity in assay V1 (sample n = 150) were 94.4 % (95 % CI, 88.2–97.9) and 97.6 % (95 % CI, 87.1–99.9). For assay (n = 55) V2 sensitivity was 92.3 % (95 % CI, 74.9–99.5) and specificity was 100 % (95 % CI, 87.7–100).
Conclusions
This study supports the feasibility of diagnosing CCHF using POC RT-qPCR platforms, having the potential to reduce turnaround times, leading to improved clinical management.
{"title":"Development and evaluation of a novel RT-qPCR assay for detection of Crimean Congo haemorrhagic fever virus using the Genedrive® point-of-care platform","authors":"Ana I. Cubas Atienzar , Christopher T. Williams , Yasemin Cosgun , Fatma Gonca Arslan , Hakan Hedef , Ilkay Bozkurt , Kevin S. Richards , Sian Summers , James Pitman , Shaun Ainsworth , Gino Miele , Cristina Leggio , William Nicholas , Hilary Bower , Benedict Gannon , Tom E. Fletcher , Gulay Korukluoglu , Thomas Edwards","doi":"10.1016/j.jcv.2025.105889","DOIUrl":"10.1016/j.jcv.2025.105889","url":null,"abstract":"<div><h3>Introduction</h3><div>Crimean-Congo haemorrhagic fever (CCHF) is a viral haemorrhagic fever classed by the World Health Organization as a priority disease due to the lack of countermeasures. A point-of-care (POC) diagnostic test for rapid detection of positive cases to expedite patient management is not currently available but urgently needed.</div></div><div><h3>Methods</h3><div>We have developed an RT-qPCR assay to be used with the commercially available POC Genedrive® PCR platform enabling viral detection in serum with minimal sample preparation. The sensitivity and specificity of the novel assay in the Genedrive® was evaluated against the RealStar® CCHFV RT-qPCR Kit (Altona Diagnostics, Germany).</div></div><div><h3>Results</h3><div>The sensitivity and specificity in assay V1 (sample n = 150) were 94.4 % (95 % CI, 88.2–97.9) and 97.6 % (95 % CI, 87.1–99.9). For assay (n = 55) V2 sensitivity was 92.3 % (95 % CI, 74.9–99.5) and specificity was 100 % (95 % CI, 87.7–100).</div></div><div><h3>Conclusions</h3><div>This study supports the feasibility of diagnosing CCHF using POC RT-qPCR platforms, having the potential to reduce turnaround times, leading to improved clinical management.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105889"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145594697","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}
Pub Date : 2026-02-01Epub Date: 2025-11-25DOI: 10.1016/j.jcv.2025.105891
Eduardo L. López , Fausto Martín Ferolla , Agustina F. Denardi , Noelia Iraizos , Ana Fernández , María M. Contrini , Patricio L. Acosta
Background
Respiratory syncytial virus is a major cause of acute respiratory infection in children. While most cases are mild, some progress to life-threatening disease. The role of bacterial colonization in shaping respiratory syncytial virus outcomes remains incompletely understood.
Objective
To evaluate the association between respiratory tract bacterial colonization and respiratory syncytial virus disease severity in children.
Study design
Prospective cohort study conducted during 2019 and 2023. Children ≤ 24 months hospitalized with confirmed positive respiratory syncytial virus infection were enrolled. Clinical and epidemiological data were collected. respiratory syncytial virus subtypes, viral load, and detection of Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis were determined by qPCR.
Results
401 patients were hospitalized with acute respiratory infection, of which 172 (42.9 %) had confirmed respiratory syncytial virus infection. Among them, 15 (8.7 %) developed life-threatening disease. Bacterial colonization was highly prevalent (92.4 %): H. influenzae (68 %), S. pneumoniae (64.5 %), and M. catarrhalis (52.9 %). M. catarrhalis colonization was associated with mild disease (p = 0.003), while H. influenzae showed a trend toward increased severity (p = 0.054). Viral subtype and viral load were not linked to severity. Household crowding was independently associated with more severe disease (p = 0.031).
Conclusions
Our results support the growing evidence that airway microbiota modulates respiratory syncytial virus outcomes and highlights M. catarrhalis as potential microbial determinant of disease progression.
{"title":"Bacterial colonization and life-threatening respiratory syncytial virus infection in children","authors":"Eduardo L. López , Fausto Martín Ferolla , Agustina F. Denardi , Noelia Iraizos , Ana Fernández , María M. Contrini , Patricio L. Acosta","doi":"10.1016/j.jcv.2025.105891","DOIUrl":"10.1016/j.jcv.2025.105891","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory syncytial virus is a major cause of acute respiratory infection in children. While most cases are mild, some progress to life-threatening disease. The role of bacterial colonization in shaping respiratory syncytial virus outcomes remains incompletely understood.</div></div><div><h3>Objective</h3><div>To evaluate the association between respiratory tract bacterial colonization and respiratory syncytial virus disease severity in children.</div></div><div><h3>Study design</h3><div>Prospective cohort study conducted during 2019 and 2023. Children ≤ 24 months hospitalized with confirmed positive respiratory syncytial virus infection were enrolled. Clinical and epidemiological data were collected. respiratory syncytial virus subtypes, viral load, and detection of <em>Haemophilus influenzae</em>, <em>Streptococcus pneumoniae</em>, and <em>Moraxella catarrhalis</em> were determined by qPCR.</div></div><div><h3>Results</h3><div>401 patients were hospitalized with acute respiratory infection, of which 172 (42.9 %) had confirmed respiratory syncytial virus infection. Among them, 15 (8.7 %) developed life-threatening disease. Bacterial colonization was highly prevalent (92.4 %): <em>H. influenzae</em> (68 %), <em>S. pneumoniae</em> (64.5 %), and <em>M. catarrhalis</em> (52.9 %). <em>M. catarrhalis</em> colonization was associated with mild disease (p = 0.003), while <em>H. influenzae</em> showed a trend toward increased severity (p = 0.054). Viral subtype and viral load were not linked to severity. Household crowding was independently associated with more severe disease (p = 0.031).</div></div><div><h3>Conclusions</h3><div>Our results support the growing evidence that airway microbiota modulates respiratory syncytial virus outcomes and highlights <em>M. catarrhalis</em> as potential microbial determinant of disease progression.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105891"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623055","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}
Pub Date : 2026-02-01Epub Date: 2025-12-26DOI: 10.1016/j.jcv.2025.105911
Joseph Mugisha , Beatrice Kimono , Sheila F. Lumley , Geraldine O’Hara , Elizabeth Waddilove , Clara Wekesa , George Mgomella , Ronald Makanga , Richard Ndungutse , Moffat Nyirenda , Chris Davis , Emma Thomson , Ponsiano Ocama , Janet Seeley , Philippa C. Matthews , Robert Newton
Background
The availability of highly effective curative direct acting antiviral (DAA) therapy for hepatitis C virus (HCV) is a cornerstone of elimination strategies. We report on long-term follow-up as part of a programme that delivered HCV screening and treatment in a population cohort in Uganda.
Methods
Screening for HCV, HIV and HBV was offered to > 7000 participants in the Kyamulibwa General Population Cohort (GPC) in Kalungu District in rural South-West Uganda in 2011. In 2017, DAA treatment was offered to those individuals who had previously tested HCV RNA positive who could still be traced, with fixed dose combination ledipasvir + sofosbuvir (LED/SOF) for 12 weeks, and post-treatment follow-up at 24 weeks. Clinical review and elastography was repeated in 2023, and verbal autopsy data reviewed.
Results
13 individuals tested HCV RNA positive, of whom five had been born in Uganda and eight originated from Rwanda. The median age at HCV diagnosis was 61 (range 48–90) and 10/13 (77 %) were male. Six years later, five had died, one had left the area, and seven individuals were traced, all of whom accepted treatment, with confirmed cure (sustained virologic response (SVR)). After a further six year interval, four of those treated were followed up. Among those who had died, a high prevalence of liver disease was suggested by verbal autopsies.
Conclusion
Among individuals offered DAA treatment, acceptance and cure rate were high. In this setting, HCV infection likely contributed to mortality, and affected older adults and migrants, suggesting these groups might be priorities for future micro-elimination programmes.
{"title":"Micro-elimination of Hepatitis C virus (HCV) infection in the General Population Cohort in rural Uganda: Long-term follow-up to assess feasibility and outcomes of a screening and treatment intervention","authors":"Joseph Mugisha , Beatrice Kimono , Sheila F. Lumley , Geraldine O’Hara , Elizabeth Waddilove , Clara Wekesa , George Mgomella , Ronald Makanga , Richard Ndungutse , Moffat Nyirenda , Chris Davis , Emma Thomson , Ponsiano Ocama , Janet Seeley , Philippa C. Matthews , Robert Newton","doi":"10.1016/j.jcv.2025.105911","DOIUrl":"10.1016/j.jcv.2025.105911","url":null,"abstract":"<div><h3>Background</h3><div>The availability of highly effective curative direct acting antiviral (DAA) therapy for hepatitis C virus (HCV) is a cornerstone of elimination strategies. We report on long-term follow-up as part of a programme that delivered HCV screening and treatment in a population cohort in Uganda.</div></div><div><h3>Methods</h3><div>Screening for HCV, HIV and HBV was offered to > 7000 participants in the Kyamulibwa General Population Cohort (GPC) in Kalungu District in rural South-West Uganda in 2011. In 2017, DAA treatment was offered to those individuals who had previously tested HCV RNA positive who could still be traced, with fixed dose combination ledipasvir + sofosbuvir (LED/SOF) for 12 weeks, and post-treatment follow-up at 24 weeks. Clinical review and elastography was repeated in 2023, and verbal autopsy data reviewed.</div></div><div><h3>Results</h3><div>13 individuals tested HCV RNA positive, of whom five had been born in Uganda and eight originated from Rwanda. The median age at HCV diagnosis was 61 (range 48–90) and 10/13 (77 %) were male. Six years later, five had died, one had left the area, and seven individuals were traced, all of whom accepted treatment, with confirmed cure (sustained virologic response (SVR)). After a further six year interval, four of those treated were followed up. Among those who had died, a high prevalence of liver disease was suggested by verbal autopsies.</div></div><div><h3>Conclusion</h3><div>Among individuals offered DAA treatment, acceptance and cure rate were high. In this setting, HCV infection likely contributed to mortality, and affected older adults and migrants, suggesting these groups might be priorities for future micro-elimination programmes.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105911"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145880090","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}
Pub Date : 2026-02-01Epub Date: 2025-11-30DOI: 10.1016/j.jcv.2025.105903
Vincent Guiraud , Sofia Ben Attia , Nathalie Hamm , Luigi Piccin , Ay Ling Leng , Agnès Gautheret-Dejean
Background
HIV rapid diagnostic tests (RDT) enable easy point-of-care screenings but traditionally lack the HIV-1 p24-antigen detection, resulting in poor diagnostic window, up to three months after exposure. Fourth-generation HIV RDTs aimed to address this issue, through independent detection of p24-antigen and HIV-antibodies, but their performances in primary infection settings remains understudied.
Objective
To compare the sensitivity of two fourth-generation HIV RDTs, Determine™ Early Detect (Determine) and AQ+ HIV Ag/Ab Combo (AQ+), in primary HIV-1 infection samples.
Methods
Sensitivity of Determine and AQ+ was assessed using 162 primary infection samples. Primary infection was determined using the New Lav blot I (Bio-Rad) Western blot, with pre-seroconversion defined by a p24-positivity with the absence of HIV-1 antibodies on the 4th generation enzyme immunoassay Liaison XL. HIV-1 infection dates were retrieved from medical records.
Results
Overall sensitivity [95 % CI] was at 94.4 % [89.8–97.1 %] and 96.9 % [93.0–98.7 %] for Determine and AQ+ , respectively (p = 0.22). Pre-seroconversion sensitivity was at 66.7 % [47.8–81.3 %] and 81.5 % [63.3–91.8 %] for Determine and AQ+ , respectively (p = 0.22). All seroconversion samples were reactive on both assays. Regarding window periods, no assay was reactive the two first weeks after infection (n = 2), Between two and three weeks after infection (n = 11), sensitivity was at 73 % [43–90 %] and 91 % [62–98 %] for Determine and AQ+ , respectively. After three weeks (n = 26), all samples were reactive on both assays, with a 100 % [87–100 %] sensitivity.
Conclusion
Fourth-generation HIV RDT can be useful for a suspected primary HIV-1 infection, but should be used with caution the first three weeks post-infection.
{"title":"Fourth generation HIV rapid diagnostic test: Adequate sensitivity in HIV primary infection settings?","authors":"Vincent Guiraud , Sofia Ben Attia , Nathalie Hamm , Luigi Piccin , Ay Ling Leng , Agnès Gautheret-Dejean","doi":"10.1016/j.jcv.2025.105903","DOIUrl":"10.1016/j.jcv.2025.105903","url":null,"abstract":"<div><h3>Background</h3><div>HIV rapid diagnostic tests (RDT) enable easy point-of-care screenings but traditionally lack the HIV-1 p24-antigen detection, resulting in poor diagnostic window, up to three months after exposure. Fourth-generation HIV RDTs aimed to address this issue, through independent detection of p24-antigen and HIV-antibodies, but their performances in primary infection settings remains understudied.</div></div><div><h3>Objective</h3><div>To compare the sensitivity of two fourth-generation HIV RDTs, Determine™ Early Detect (Determine) and AQ+ HIV Ag/Ab Combo (AQ+), in primary HIV-1 infection samples.</div></div><div><h3>Methods</h3><div>Sensitivity of Determine and AQ+ was assessed using 162 primary infection samples. Primary infection was determined using the New Lav blot I (Bio-Rad) Western blot, with pre-seroconversion defined by a p24-positivity with the absence of HIV-1 antibodies on the 4th generation enzyme immunoassay Liaison XL. HIV-1 infection dates were retrieved from medical records.</div></div><div><h3>Results</h3><div>Overall sensitivity [95 % CI] was at 94.4 % [89.8–97.1 %] and 96.9 % [93.0–98.7 %] for Determine and AQ+ , respectively (p = 0.22). Pre-seroconversion sensitivity was at 66.7 % [47.8–81.3 %] and 81.5 % [63.3–91.8 %] for Determine and AQ+ , respectively (p = 0.22). All seroconversion samples were reactive on both assays. Regarding window periods, no assay was reactive the two first weeks after infection (n = 2), Between two and three weeks after infection (n = 11), sensitivity was at 73 % [43–90 %] and 91 % [62–98 %] for Determine and AQ+ , respectively. After three weeks (n = 26), all samples were reactive on both assays, with a 100 % [87–100 %] sensitivity.</div></div><div><h3>Conclusion</h3><div>Fourth-generation HIV RDT can be useful for a suspected primary HIV-1 infection, but should be used with caution the first three weeks post-infection.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105903"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145677715","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}
Pub Date : 2026-02-01Epub Date: 2025-11-14DOI: 10.1016/j.jcv.2025.105888
{"title":"2025 JCV reviewer recognition list and best reviewer awards","authors":"","doi":"10.1016/j.jcv.2025.105888","DOIUrl":"10.1016/j.jcv.2025.105888","url":null,"abstract":"","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105888"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145819433","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}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号