Journal of Clinical Virology最新文献

{"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 ,&nbsp;Xinyi Xiang ,&nbsp;Hongqian Xu ,&nbsp;Wencen Lu ,&nbsp;JinJing Zhang ,&nbsp;Zhili Hu ,&nbsp;Shiying Li ,&nbsp;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}

{"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,&nbsp;Dominik Nörz,&nbsp;Katja Giersch,&nbsp;Moritz Grunwald,&nbsp;Hui Ting Tang,&nbsp;Lisa Sophie Pflüger,&nbsp;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}

{"title":"Detection of La Crosse virus RNA in clinical specimens obtained from children with La Crosse infection","authors":"Huanyu Wang ,&nbsp;Kathy Everhart ,&nbsp;Sophonie J. Oyeniran ,&nbsp;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}

{"title":"Practical management of positive norovirus results from FilmArray® GI panel","authors":"Noémie Rybak ,&nbsp;Philippe Bidet ,&nbsp;Yasmine Benhadid-Brahmi ,&nbsp;Aurélie Cointe ,&nbsp;Hosam Dawoud ,&nbsp;Maud Gits-Muselli ,&nbsp;Audrey Baron ,&nbsp;Stéphane Bonacorsi ,&nbsp;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 (&gt; 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}

{"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 ,&nbsp;Christopher T. Williams ,&nbsp;Yasemin Cosgun ,&nbsp;Fatma Gonca Arslan ,&nbsp;Hakan Hedef ,&nbsp;Ilkay Bozkurt ,&nbsp;Kevin S. Richards ,&nbsp;Sian Summers ,&nbsp;James Pitman ,&nbsp;Shaun Ainsworth ,&nbsp;Gino Miele ,&nbsp;Cristina Leggio ,&nbsp;William Nicholas ,&nbsp;Hilary Bower ,&nbsp;Benedict Gannon ,&nbsp;Tom E. Fletcher ,&nbsp;Gulay Korukluoglu ,&nbsp;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}

{"title":"Bacterial colonization and life-threatening respiratory syncytial virus infection in children","authors":"Eduardo L. López ,&nbsp;Fausto Martín Ferolla ,&nbsp;Agustina F. Denardi ,&nbsp;Noelia Iraizos ,&nbsp;Ana Fernández ,&nbsp;María M. Contrini ,&nbsp;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}

{"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 ,&nbsp;Beatrice Kimono ,&nbsp;Sheila F. Lumley ,&nbsp;Geraldine O’Hara ,&nbsp;Elizabeth Waddilove ,&nbsp;Clara Wekesa ,&nbsp;George Mgomella ,&nbsp;Ronald Makanga ,&nbsp;Richard Ndungutse ,&nbsp;Moffat Nyirenda ,&nbsp;Chris Davis ,&nbsp;Emma Thomson ,&nbsp;Ponsiano Ocama ,&nbsp;Janet Seeley ,&nbsp;Philippa C. Matthews ,&nbsp;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 &gt; 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}

{"title":"Fourth generation HIV rapid diagnostic test: Adequate sensitivity in HIV primary infection settings?","authors":"Vincent Guiraud ,&nbsp;Sofia Ben Attia ,&nbsp;Nathalie Hamm ,&nbsp;Luigi Piccin ,&nbsp;Ay Ling Leng ,&nbsp;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}

{"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}

{"title":"Is there a need to repeat single assay reactive HIV screens? A review of practice in two UK sites","authors":"Callum Goolden ,&nbsp;Cheryl Williams ,&nbsp;Sabeen Khurshid Zaidi ,&nbsp;Joel Paul ,&nbsp;Dominic Haigh ,&nbsp;Emma Davies ,&nbsp;Shazaad Ahmad ,&nbsp;Nicholas Machin ,&nbsp;Thomas Whitfield","doi":"10.1016/j.jcv.2025.105906","DOIUrl":"10.1016/j.jcv.2025.105906","url":null,"abstract":"<div><h3>Background</h3><div>In the United Kingdom, a 3-step algorithm for HIV screening is standard practice. Where there is discordancy between different serological assays, the interpretation of HIV status is challenging and guidance on reporting and follow up is conflicting. Inconclusive HIV results often prompt requests for repeat testing which is known to cause considerable anxiety as well as increased healthcare costs.</div></div><div><h3>Objectives</h3><div>We aimed to demonstrate the safety and efficacy of reporting single assay reactive HIV screens with a negative serum HIV-1 RNA PCR result as HIV negative, without the requirement for repeat sampling.</div></div><div><h3>Study design</h3><div>We conducted a retrospective review of local practice across two neighbouring NHS trusts. HIV results were reviewed to determine the proportion of single assay reactivity and to assess if any individuals exhibiting single assay reactivity were found to be HIV-1 positive by PCR, or with interval serological testing.</div></div><div><h3>Results</h3><div>A total of 1225 (0.26 %) of HIV screening requests exhibited single assay reactivity. None of these were found to be HIV-1 positive by PCR. 356 individuals with single assay reactivity had repeat testing performed, but none were shown to have developed HIV infection.</div></div><div><h3>Conclusions</h3><div>In our cohort, specimens exhibiting single HIV assay reactivity did not confirm when tested for HIV-1 RNA by PCR, or with interval serological testing of the source individual. This demonstrates the safety and efficacy of a longstanding approach at both NHS trusts.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105906"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145714576","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}