Viruses-Basel最新文献

{"title":"Real-World Experience with Long-Acting Injectable Cabotegravir/Rilpivirine in HIV Patients with Unsuppressed Viral Load.","authors":"Marcello Trizzino, Luca Pipitò, Pierluigi Francesco Salvo, Federica Zimmerhofer, Andrea Cicero, Gianmaria Baldin, Claudia Conti, Claudia Gioè, Simona Di Giambenedetto, Antonio Cascio","doi":"10.3390/v17091254","DOIUrl":"10.3390/v17091254","url":null,"abstract":"<p><p>Long-acting injectable cabotegravir/rilpivirine (CAB/RPV-LA) is currently approved as a maintenance therapy for people with HIV (PWH) who are virologically suppressed. However, growing real-world evidence highlights its potential role in more complex viremic populations traditionally considered ineligible. We present a case series of eight PWH treated at two tertiary centers in Italy, all of whom faced persistent viremia, adherence difficulties, malabsorption syndromes, or psychosocial barriers. Following the switch to CAB/RPV-LA, all patients, despite heterogeneous clinical profiles and baseline virological status, achieved and maintained virologic suppression, demonstrated improved adherence, and experienced no serious adverse events.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474475/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic Performance of Salivary PCR for the Detection of Congenital Cytomegalovirus: A Systematic Review and Meta-Analysis.","authors":"Sara Mohammed Ahmed Rady, Mahmoud Ibrahim Abdelmoati, Sara Sabra, Maryam Alameddine, Suchita Dsilva, Jeevan K Shetty","doi":"10.3390/v17091253","DOIUrl":"10.3390/v17091253","url":null,"abstract":"<p><p>Congenital cytomegalovirus (CMV) is a major cause of neonatal morbidity, particularly sensorineural hearing loss, yet its early detection remains challenging. While urinary PCR is the current diagnostic gold standard, its implementation in neonatal settings is often limited by feasibility issues. Salivary PCR presents a more practical alternative, but its diagnostic accuracy has remained uncertain. This systematic review and meta-analysis aimed to evaluate the performance of salivary PCR compared to urinary PCR in detecting congenital CMV in neonates. Following PRISMA guidelines, 15 observational studies involving 29,617 neonates were analyzed using a random-effects model. Pooled sensitivity and specificity were 0.99 and 1.00, respectively, with a negative predictive value (NPV) of 1.00 and a positive predictive value (PPV) of 0.91, despite moderate heterogeneity. Subgroup analysis showed high diagnostic performance across general neonates, infants of seropositive mothers and high-risk neonates (referring to neonates that are small for their gestational age (SGA), neonates who failed hearing screening, and neonates with CMV-related congenital abnormalities). The general group had the highest specificity (0.999), while high-risk neonates showed the highest sensitivity (0.981). Across all groups, NPV remained consistently above 0.994, with PPV ranging from 0.848 to 0.981. These findings confirm that salivary PCR is a highly accurate and feasible tool for congenital CMV diagnosis.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474390/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Network Meta-Analytical Investigations of the Performance of HIV Combination Prevention Strategies for Indigenous Populations.","authors":"Marcos Jessé Abrahão Silva, Rebecca Lobato Marinho, Daniele Melo Sardinha, Diego Rafael Lima Batista, Luiza Raquel Tapajós Figueira, Tamires de Nazaré Soares, Keitty Anne Silva Neves, Aloma Mapinik Suruí, Manuella Nunes Colaço, Vinicius Dos Santos Peniche, Ligia Regina Franco Sansigolo Kerr, Sebastião Kauã de Sousa Bispo, Ana Judith Pires Garcia, Carl Kendall, Luana Nepomuceno Gondim Costa Lima","doi":"10.3390/v17091247","DOIUrl":"10.3390/v17091247","url":null,"abstract":"<p><strong>Background: </strong>Indigenous populations worldwide face a disproportionate burden of HIV due to structural inequities, cultural marginalization, and limited access to health services. Despite growing recognition of the need for culturally adapted responses, the effectiveness of combination HIV prevention strategies in these communities remains underexplored.</p><p><strong>Objectives: </strong>This study aimed to evaluate and compare the effectiveness of multiple HIV prevention strategies among Indigenous populations using a systematic review and network meta-analysis (NMA), to inform equity-oriented public health interventions.</p><p><strong>Methods: </strong>Following PRISMA-NMA 2020 guidelines, a comprehensive literature search was conducted across four databases (PubMed, SciELO, LILACS, Science Direct) for quantitative studies published between January 2000 and June 2025. Eligible studies evaluated HIV prevention interventions among Indigenous populations and reported risk or odds ratios. A frequentist NMA model was used to calculate effect estimates (OR, 95% CI) and SUCRA rankings for seven types of interventions, combining biomedical, behavioral, and structural approaches.</p><p><strong>Results: </strong>Four high-to-moderate quality studies enclosing 4523 participants were included. The most effective intervention was home-based counseling and testing for HIV, followed by medical consultation combined with HIV testing. Standalone testing, while effective, was significantly less impactful than when combined with culturally sensitive educational strategies. Information-only strategies showed the least efficacy. The SUCRA analysis ranked home-based testing highest (45.17%), highlighting the importance of decentralization, community participation, and intercultural mediation.</p><p><strong>Conclusions: </strong>Culturally adapted combination prevention strategies-especially those integrating home-based testing and counseling-are more effective than isolated biomedical interventions in Indigenous populations. These findings reinforce the urgent need for participatory, context-driven public health responses that center Indigenous knowledge, reduce stigma, and expand equitable access to HIV care and prevention.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474319/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: de Lima et al. Antiviral and Virucidal Activities of <i>Uncaria tomentosa</i> (Cat's Claw) against the Chikungunya Virus. <i>Viruses</i> 2024, <i>16</i>, 369.","authors":"Raquel Curtinhas de Lima, Ligia Maria Marino Valente, Débora Familiar Macedo, Luzia Maria de-Oliveira-Pinto, Flavia Barreto Dos Santos, José Luiz Mazzei, Antonio Carlos Siani, Priscila Conrado Guerra Nunes, Elzinandes Leal de Azeredo","doi":"10.3390/v17091244","DOIUrl":"10.3390/v17091244","url":null,"abstract":"<p><p>There was an error in the original publication [...].</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474116/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HCV Screening in a Sicilian Centre: A Descriptive Cohort Profile.","authors":"Maria G Minissale, Salvatore Petta, Fabio Cartabellotta","doi":"10.3390/v17091252","DOIUrl":"10.3390/v17091252","url":null,"abstract":"<p><strong>Introduction: </strong>Hepatitis C virus (HCV) infection prevalence in Italy varies according to geographical areas and clusters of infection. Moreover, epidemiological studies are old, and the actual prevalence of HCV active infections is also affected by the use of direct-acting antiviral therapies (DAAs) that achieve sustained virologic response (SVR) in >95% of treated patients. We aimed to evaluate the prevalence of HCV infections in in- or outpatients referred to a Sicilian hospital.</p><p><strong>Materials and methods: </strong>The study was conducted in the Buccheri La Ferla Hospital, in Palermo (Sicily), from 1 November 2019 to March 2022. We consecutively screened for HCV infections all inpatients who were evaluated on admission to the ward and all outpatients who referred to the central laboratory. All patients were screened using serological detection of HCV antibodies.</p><p><strong>Results: </strong>In the entire cohort, 469 out of 15,550 patients (3%) showed anti-HCV positivity, and this rate progressively increased according to classes of age (0.4% for <40 yrs, 3% for 40-60 yrs, 4% for >60-80 yrs, and 6.4% for >80 yrs). Among patients with anti-HCV positivity, 44.3% were HCV-RNA negative, 39.2% had HCV-RNA not available, and 16.4% were HCV-RNA positive. In total, 44.1% of patients with HCV-RNA positivity underwent DAA-based antiviral therapy.</p><p><strong>Conclusions: </strong>HCV screening programs can be useful in identifying infected patients at risk of liver disease progression and/or infection spreading. The implementation of laboratory strategies based on HCV reflex testing, the activation of dedicated linkage-to-care plans, and a focus on higher-risk groups could increase the effectiveness of screening programs.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virome Analysis of Small Mammals from the Brazilian Amazon.","authors":"Leonardo Henrique Almeida Hernández, Fábio Silva da Silva, Thito Yan Bezerra da Paz, Daniel Damous Dias, Bruno de Cássio Veloso de Barros, Bruno Tardelli Diniz Nunes, Lívia Medeiros Neves Casseb, Sandro Patroca da Silva, Pedro Fernando da Costa Vasconcelos, Ana Cecília Ribeiro Cruz","doi":"10.3390/v17091251","DOIUrl":"10.3390/v17091251","url":null,"abstract":"<p><p>The municipalities of Peixe-Boi and Santa Bárbara do Pará, both in the Pará State (eastern Amazon), have more than half of their territory deforested. Understanding the viral diversity in wildlife that inhabits the surroundings of human communities contributes to strengthening surveillance. Samples from eleven bats, seven opossums, and eight rodents from the two locations were screened by high-throughput sequencing for virome analysis. Viral reads were assigned into twenty viral families, from which the most abundant was <i>Retroviridae</i>. Host order, tissue type, and season showed a significant effect on viral composition. Five viral genomes of bat ERVs with intact genes were recovered, showing the need to understand their endogenous nature. In addition, a new Buritiense virus (<i>Hantaviridae</i>) strain was also obtained, supporting its circulation in Santa Bárbara do Pará and expanding its genomic information. Together, these findings reinforce the need for continuous surveillance in wild animals, especially in the Amazon region, to anticipate potential threats to public health.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474034/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Heat Stress Induces Partial Resistance to Tomato Bushy Stunt Virus in <i>Nicotiana benthamiana</i> Via Combined Stress Pathways.","authors":"Nurgul Iksat, Almas Madirov, Dana Artykbayeva, Oleksiy Shevchenko, Kuralay Zhanassova, Zhaksat Baikarayev, Zhaksylyk Masalimov","doi":"10.3390/v17091250","DOIUrl":"10.3390/v17091250","url":null,"abstract":"<p><p>Global climate change is the impact of combined abiotic and biotic stresses negatively affecting plant health and productivity. This study investigated the molecular and cellular responses of <i>Nicotiana benthamiana</i> L. plants to wild-type tomato bushy stunt virus (wtTBSV) infection under conditions of pre-existing heat stress. The experiments were conducted under controlled temperature regimes of 30 °C and 37 °C in combination with virus challenge. Morphological and biochemical analyses in plants under the influence of combined stress showed the alleviation of disease symptoms, reduction in virus content and reduced expression levels of viral proteins P19 and P33. Under conditions of combined stress, accumulation of hydrogen peroxide and malondialdehyde, as well as activation of the antioxidant enzyme catalase, especially in root tissues, were observed. Notably, at 37 °C, virus infection was suppressed despite high levels of oxidative stress, whereas at 30 °C, a marked decrease in the expression of host factors was observed. The results indicate that thermal stress modulates virus-host interactions and activates defense mechanisms, including antioxidant and RNA interference pathways. Therefore, temperature adaptation can be considered as a promising strategy for enhancing plant resistance to viral pathogens under climate changes.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474339/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical, Psychosocial, and Structural Factors Associated with the Detection of HIV Drug Resistance in Children Living with HIV in Kisumu, Kenya: Secondary Analysis of Data from the Opt4Kids Study.","authors":"Andrea J Scallon, Pooja Maheria, Patrick Oyaro, Katherine K Thomas, Bhavna H Chohan, Francesca Odhiambo, Evelyn Brown, Edwin Ochomo, Enericah Karauki, Nashon Yongo, Shukri A Hassan, Marley D Bishop, Ingrid A Beck, Ceejay Boyce, Lisa M Frenkel, Lisa Abuogi, Rena C Patel","doi":"10.3390/v17091246","DOIUrl":"10.3390/v17091246","url":null,"abstract":"<p><strong>Background: </strong>HIV drug resistance (DR) mutations can compromise antiretroviral therapy (ART) success among children living with HIV (CLHIV). We conducted a secondary analysis using data from a randomized control trial for ART monitoring among CLHIV in Kisumu County, Kenya from 2019 to 2023, to assess clinical, psychosocial, and structural factors associated with HIV DR.</p><p><strong>Methods: </strong>704 CLHIV were followed for 12+ months, with characteristics captured at enrollment and follow-up visits in the \"parent\" randomized-controlled-trial (of point-of-care plasma viral load testing and for viremias ≥ 1000 copies/mL HIV genotyping for DR vs. standard-of-care) and an observational \"extension\" substudy (of participants on a dolutegravir-containing ART with genotyping performed on viremic specimens ≥ 200 copies/mL). A multivariate modified Poisson regression model was used to analyze factors associated with sequences yielding a Stanford HIVDR database DR penalty score (DR-PS) ≥ 30 to a nucleos(t)ides and/or non-nucleoside reverse transcriptase inhibitor, protease inhibitor (PI), and/or integrase inhibitor (INSTI).</p><p><strong>Results: </strong>Among 113 (16.1%) participants who underwent genotyping, 93 (82.3%) had a DR-PS ≥ 30. DR-PS ≥ 30 were associated with age 1-5 years (adjusted risk ratio (ARR) = 1.84; 95% confidence interval (CI): 1.07, 3.14), history of viremia ≥ 1000 copies/mL (ARR = 4.18; 95% CI: 2.77, 6.31), prescription of a PI- (ARR = 6.05; 95% CI: 3.43, 10.68) or INSTI-containing regimen (ARR = 1.83; 95% CI: 1.08, 3.11), poor adherence to ART (ARR = 1.91; 95% CI: 1.32, 2.76), lack of caregiver confidence in ART administration (ARR = 1.89; 95% CI: 1.11, 3.22), and mid-sized clinic populations (ARR = 0.55; 95% CI: 0.33, 0.92).</p><p><strong>Conclusion: </strong>Addressing social factors associated with DR-PS ≥ 30 may improve ART success among CLHIV.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An HTLV-1-Infected Humanized Mouse Model Expressing HLA-A*02:01 Demonstrates Effective CTL-Mediated Suppression of HTLV-1.","authors":"Shinsuke Nakajima, Motohito Goto, Sung-Il Lee, Tokifumi Odaka, Masaki Hino, Kenta Tezuka, Norihiro Takenouchi, Takaharu Ueno, Fhahira Rizkhika Admadiani, Riichi Takahashi, Isao Hamaguchi, Takeshi Takahashi, Mamoru Ito, Kazu Okuma","doi":"10.3390/v17091249","DOIUrl":"10.3390/v17091249","url":null,"abstract":"<p><p>Human T-cell leukemia virus type 1 (HTLV-1) establishes lifelong infection and is associated with severe diseases such as adult T-cell leukemia/lymphoma (ATL) and HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP). Cytotoxic T lymphocytes (CTLs), especially those specific for the viral protein Tax, play a pivotal role in controlling HTLV-1 infection. However, conventional humanized mouse models fail to fully reconstitute human immune responses, limiting their utility for evaluating CTL-mediated immunity. This study aimed to establish a physiologically relevant in vivo model to investigate human CTL responses against HTLV-1. To achieve this, we utilized NOG-HLA-A02 transgenic (Tg) mice expressing human HLA-A02:01 on thymic epithelial cells, enabling proper development of HLA-restricted human T cells. Compared to conventional humanized NOG mice, HTLV-1-infected humanized NOG-HLA-A02 Tg mice exhibited significantly reduced HTLV-1 proviral load (PVL), decreased expansion of infected CD4⁺ T cells, a trend toward increased frequencies of Tax-specific CD8⁺ T cells, and prolonged survival. These results demonstrate that the expression of HLA-A02:01 facilitates robust CTL-mediated immune control of HTLV-1. This model provides a powerful platform for dissecting HTLV-1 immunopathogenesis and evaluating CTL-targeted therapeutic strategies, including vaccines and immune checkpoint inhibitors.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the Impact of SARS-CoV-2 Spike Mutations on Antibody Binding: A Comparative Assessment of the Wuhan and JN.1 Variants' Full-Length Spikes in a Multiplex Luminex Assay.","authors":"Gerald Waweru, Ruth Nyakundi, Bernadette Kutima, Sharon Owuor, Gloria Konyino, John Gitonga, Doreen Lugano, Angela Maina, Jennifer Musyoki, Lucy Ochola, Martin Omondi, Christopher K Kariuki, Paul Ogongo, Christina Mwachari, Faiz Shee, Charles Agoti, Charles Sande, Sophie Uyoga, Eunice Kagucia, Ambrose Agweyu, Philip Bejon, J Anthony G Scott, George M Warimwe, L Isabella Ochola-Oyier, James Nyagwange","doi":"10.3390/v17091248","DOIUrl":"10.3390/v17091248","url":null,"abstract":"<p><p>Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) continues to evolve, with mutations leading to the emergence of new variants. JN.1, a subvariant of omicron BA.2.86, has demonstrated marked immune escape and is now included in updated vaccine formulations. While reduced sensitivity has been reported for antibody assays using ancestral spike protein subunits to detect omicron-induced responses, the performance of full-length spike-based assays against omicron sublineages remains unclear. We aimed to compare the sensitivity of ELISA and Luminex assays using full-length spike proteins from the ancestral Wuhan strain and the JN.1 variant.</p><p><strong>Methods: </strong>Wuhan and JN.1 full-length spike protein constructs were designed and expressed in Expi293F mammalian cells. In-house ELISAs based on previously validated protocols were used to measure anti-spike IgG levels. Additionally, a Luminex-based assay for anti-spike antibody detection was developed and validated. Both assays were applied to the following sample groups: pre-pandemic samples (designated \"gold standard negatives\"); PCR confirmed 2020 positives (\"gold standard wildtype positives\"); PCR confirmed 2024 positives (\"gold standard omicron positives\"); 2022 vaccinated individuals with verbal confirmed infection (\"gold standard hybrid positives\"); and 2024 household samples (\"unknowns\").</p><p><strong>Results: </strong>Wuhan spike protein showed a sensitivity of 100% (95% CI: 0.88-1.0) in detecting omicron-specific antibodies using gold standard omicron positives with JN.1 spike protein as a reference assay. Overall, across all samples, in ELISA, the Wuhan antigen had a sensitivity of 0.93 (95% CI: 0.89-0.95) and a specificity of 0.98 (95% CI: 0.94-0.99). The JN.1 antigen showed a sensitivity of 0.91 (95% CI: 0.87-0.94) and a specificity of 0.97 (95% CI: 0.93-0.99). In Luminex, sensitivity was 0.95 (95% CI: 0.91-0.97) for Wuhan and 0.94 (95% CI: 0.91-0.96) for JN.1. Specificity for both antigens in Luminex was 0.98 (95% CI: 0.94-0.99).</p><p><strong>Conclusions: </strong>Both ELISA and Luminex assays showed comparable sensitivity and specificity for both Wuhan and JN.1 antigens, indicating that mutations in the JN.1 variant do not significantly impact assay performance. This suggests preserved antigenic recognition across variants.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}