Romina Salpini, Lorenzo Piermatteo, Gian Paolo Caviglia, Ada Bertoli, Maurizia Rossana Brunetto, Bianca Bruzzone, Annapaola Callegaro, Cinzia Caudai, Daniela Cavallone, Luchino Chessa, Fernando Coghe, Nicola Coppola, Nunzia Cuomo, Stefano D'Anna, Mariantonietta Di Stefano, Floriana Facchetti, Claudio Farina, Donatella Ferraro, Elisa Franchin, Daniela Francisci, Silvia Galli, Anna Rosa Garbuglia, William Gennari, Valeria Ghisetti, Pietro Lampertico, Sergio Lo Caputo, Nadia Marascio, Stefano Menzo, Valeria Micheli, Grazia Anna Niro, Antonella Olivero, Pierpaolo Paba, Concetta Ilenia Palermo, Orazio Palmieri, Stefania Paolucci, Mariantonietta Pisaturo, Teresa Pollicino, Giuseppina Raffa, Teresa Santantonio, Giulia Torre, Ombretta Turriziani, Sergio Uzzau, Sara Colonia Uceda Renteria, Marialinda Vatteroni, Maurizio Zazzi, Antonio Craxì, Francesca Ceccherini-Silberstein, Valentina Svicher, Marco Arosio, Sabrina Bastianelli, Annamaria Gentile, Federica A M Giardina, Anna Gidari, Rosalba Govoni, Gabriele Ibba, Alessandro Loglio, Alessandra Lombardi, Chiara Mascarella, Fabrizio Maggi, Giovanni Matera, Chiara Mazzei, Maria Grazia Milia, Angela Quirino, Adriana Raddi, Rosetta Scioscia, Sara Tagliazucchi, Michele Totaro, Rea Valaperta
{"title":"临床实践中使用的HDV-RNA定量分析诊断性能的比较：来自一项国家质量控制多中心研究的结果。","authors":"Romina Salpini, Lorenzo Piermatteo, Gian Paolo Caviglia, Ada Bertoli, Maurizia Rossana Brunetto, Bianca Bruzzone, Annapaola Callegaro, Cinzia Caudai, Daniela Cavallone, Luchino Chessa, Fernando Coghe, Nicola Coppola, Nunzia Cuomo, Stefano D'Anna, Mariantonietta Di Stefano, Floriana Facchetti, Claudio Farina, Donatella Ferraro, Elisa Franchin, Daniela Francisci, Silvia Galli, Anna Rosa Garbuglia, William Gennari, Valeria Ghisetti, Pietro Lampertico, Sergio Lo Caputo, Nadia Marascio, Stefano Menzo, Valeria Micheli, Grazia Anna Niro, Antonella Olivero, Pierpaolo Paba, Concetta Ilenia Palermo, Orazio Palmieri, Stefania Paolucci, Mariantonietta Pisaturo, Teresa Pollicino, Giuseppina Raffa, Teresa Santantonio, Giulia Torre, Ombretta Turriziani, Sergio Uzzau, Sara Colonia Uceda Renteria, Marialinda Vatteroni, Maurizio Zazzi, Antonio Craxì, Francesca Ceccherini-Silberstein, Valentina Svicher, Marco Arosio, Sabrina Bastianelli, Annamaria Gentile, Federica A M Giardina, Anna Gidari, Rosalba Govoni, Gabriele Ibba, Alessandro Loglio, Alessandra Lombardi, Chiara Mascarella, Fabrizio Maggi, Giovanni Matera, Chiara Mazzei, Maria Grazia Milia, Angela Quirino, Adriana Raddi, Rosetta Scioscia, Sara Tagliazucchi, Michele Totaro, Rea Valaperta","doi":"10.1016/j.jcv.2025.105850","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>A reliable quantification of hepatitis D virus (HDV) RNA is of paramount importance for monitoring patients under antiviral therapy. This quality control study compares the diagnostic performances of quantitative HDV-RNA assays used in clinical practice.</p><p><strong>Methods: </strong>Two HDV-RNA sample panels were quantified in 30 centers by RoboGene (N = 9 laboratories), EurobioPlex (N = 7), RealStar (N = 4), AltoStar (N = 1), Bosphore (N = 3), Bosphore-on-InGenius (N = 1), Dia.Pro (N = 2), Nuclear-Laser-Medicine (N = 1) and 3 in-house assays. Panel A and B comprised 8 serial dilutions of WHO/HDV standard (range: 0.5-5.0 log10 IU/ml) and 20 clinical samples (range: 0.5-6.0 log10 IU/ml), respectively. The following parameters were determined: sensitivity by 95 % LOD (limit of detection), precision by intra- and inter-run CV (coefficient of variation), accuracy by the differences between expected-observed HDV-RNA, linearity by linear regression analysis.</p><p><strong>Results: </strong>95 % LOD varied across assays and centers underlining heterogeneous sensitivities: AltoStar had the lowest 95 % LOD (3 IU/ml) followed by RealStar (10 [min-max: 3-316] IU/ml), Bosphore-on-InGenius (10 IU/ml), RoboGene (31 [3-316] IU/ml), Nuclear-Laser-Medicine (31 IU/ml) and EuroBioplex (100 [100-316] IU/ml). Moreover, 6 assays (RoboGene, EurobioPlex, RealStar, AltoStar, Nuclear-Laser-Medicine and In-house) showed <0.5 log10 IU/ml differences between expected and observed HDV-RNA for all dilutions while other assays had >1 log10 IU/ml underestimations. RealStar, Bosphore-on-InGenius and EurobioPlex had the highest precision (mean intra-run CV < 20 %). Inter-run CV was higher for all assays, with CVs < 25 % for RealStar, AltoStar, Nuclear-Laser-Medicine and EurobioPlex. Seven assays (RoboGene/AltoStar/RealStar/EurobioPlex/Nuclear-Laser-Medicine/In-house) showed a good linearity (R<sup>2</sup> > 0.90), but for HDV-RNA < 1000 IU/ml only Bosphore-on-InGenius, AltoStar, RealStar and Robogene showed a R<sup>2</sup> > 0.85.</p><p><strong>Conclusions: </strong>This study underlines heterogeneous sensitivities (inter- and intraassays), that could hamper proper HDV-RNA quantification, particularly at low viral loads. This raises the need to improve the diagnostic performance of most assays for properly identifying virological response to anti-HDV drugs.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105850"},"PeriodicalIF":3.4000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparison of diagnostic performances of HDV-RNA quantification assays used in clinical practice: Results from a national quality control multicenter study.\",\"authors\":\"Romina Salpini, Lorenzo Piermatteo, Gian Paolo Caviglia, Ada Bertoli, Maurizia Rossana Brunetto, Bianca Bruzzone, Annapaola Callegaro, Cinzia Caudai, Daniela Cavallone, Luchino Chessa, Fernando Coghe, Nicola Coppola, Nunzia Cuomo, Stefano D'Anna, Mariantonietta Di Stefano, Floriana Facchetti, Claudio Farina, Donatella Ferraro, Elisa Franchin, Daniela Francisci, Silvia Galli, Anna Rosa Garbuglia, William Gennari, Valeria Ghisetti, Pietro Lampertico, Sergio Lo Caputo, Nadia Marascio, Stefano Menzo, Valeria Micheli, Grazia Anna Niro, Antonella Olivero, Pierpaolo Paba, Concetta Ilenia Palermo, Orazio Palmieri, Stefania Paolucci, Mariantonietta Pisaturo, Teresa Pollicino, Giuseppina Raffa, Teresa Santantonio, Giulia Torre, Ombretta Turriziani, Sergio Uzzau, Sara Colonia Uceda Renteria, Marialinda Vatteroni, Maurizio Zazzi, Antonio Craxì, Francesca Ceccherini-Silberstein, Valentina Svicher, Marco Arosio, Sabrina Bastianelli, Annamaria Gentile, Federica A M Giardina, Anna Gidari, Rosalba Govoni, Gabriele Ibba, Alessandro Loglio, Alessandra Lombardi, Chiara Mascarella, Fabrizio Maggi, Giovanni Matera, Chiara Mazzei, Maria Grazia Milia, Angela Quirino, Adriana Raddi, Rosetta Scioscia, Sara Tagliazucchi, Michele Totaro, Rea Valaperta\",\"doi\":\"10.1016/j.jcv.2025.105850\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>A reliable quantification of hepatitis D virus (HDV) RNA is of paramount importance for monitoring patients under antiviral therapy. This quality control study compares the diagnostic performances of quantitative HDV-RNA assays used in clinical practice.</p><p><strong>Methods: </strong>Two HDV-RNA sample panels were quantified in 30 centers by RoboGene (N = 9 laboratories), EurobioPlex (N = 7), RealStar (N = 4), AltoStar (N = 1), Bosphore (N = 3), Bosphore-on-InGenius (N = 1), Dia.Pro (N = 2), Nuclear-Laser-Medicine (N = 1) and 3 in-house assays. Panel A and B comprised 8 serial dilutions of WHO/HDV standard (range: 0.5-5.0 log10 IU/ml) and 20 clinical samples (range: 0.5-6.0 log10 IU/ml), respectively. The following parameters were determined: sensitivity by 95 % LOD (limit of detection), precision by intra- and inter-run CV (coefficient of variation), accuracy by the differences between expected-observed HDV-RNA, linearity by linear regression analysis.</p><p><strong>Results: </strong>95 % LOD varied across assays and centers underlining heterogeneous sensitivities: AltoStar had the lowest 95 % LOD (3 IU/ml) followed by RealStar (10 [min-max: 3-316] IU/ml), Bosphore-on-InGenius (10 IU/ml), RoboGene (31 [3-316] IU/ml), Nuclear-Laser-Medicine (31 IU/ml) and EuroBioplex (100 [100-316] IU/ml). Moreover, 6 assays (RoboGene, EurobioPlex, RealStar, AltoStar, Nuclear-Laser-Medicine and In-house) showed <0.5 log10 IU/ml differences between expected and observed HDV-RNA for all dilutions while other assays had >1 log10 IU/ml underestimations. RealStar, Bosphore-on-InGenius and EurobioPlex had the highest precision (mean intra-run CV < 20 %). Inter-run CV was higher for all assays, with CVs < 25 % for RealStar, AltoStar, Nuclear-Laser-Medicine and EurobioPlex. Seven assays (RoboGene/AltoStar/RealStar/EurobioPlex/Nuclear-Laser-Medicine/In-house) showed a good linearity (R<sup>2</sup> > 0.90), but for HDV-RNA < 1000 IU/ml only Bosphore-on-InGenius, AltoStar, RealStar and Robogene showed a R<sup>2</sup> > 0.85.</p><p><strong>Conclusions: </strong>This study underlines heterogeneous sensitivities (inter- and intraassays), that could hamper proper HDV-RNA quantification, particularly at low viral loads. This raises the need to improve the diagnostic performance of most assays for properly identifying virological response to anti-HDV drugs.</p>\",\"PeriodicalId\":15517,\"journal\":{\"name\":\"Journal of Clinical Virology\",\"volume\":\"180 \",\"pages\":\"105850\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Virology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jcv.2025.105850\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/8/6 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"VIROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Virology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jcv.2025.105850","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/6 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"VIROLOGY","Score":null,"Total":0}
Comparison of diagnostic performances of HDV-RNA quantification assays used in clinical practice: Results from a national quality control multicenter study.
Introduction: A reliable quantification of hepatitis D virus (HDV) RNA is of paramount importance for monitoring patients under antiviral therapy. This quality control study compares the diagnostic performances of quantitative HDV-RNA assays used in clinical practice.
Methods: Two HDV-RNA sample panels were quantified in 30 centers by RoboGene (N = 9 laboratories), EurobioPlex (N = 7), RealStar (N = 4), AltoStar (N = 1), Bosphore (N = 3), Bosphore-on-InGenius (N = 1), Dia.Pro (N = 2), Nuclear-Laser-Medicine (N = 1) and 3 in-house assays. Panel A and B comprised 8 serial dilutions of WHO/HDV standard (range: 0.5-5.0 log10 IU/ml) and 20 clinical samples (range: 0.5-6.0 log10 IU/ml), respectively. The following parameters were determined: sensitivity by 95 % LOD (limit of detection), precision by intra- and inter-run CV (coefficient of variation), accuracy by the differences between expected-observed HDV-RNA, linearity by linear regression analysis.
Results: 95 % LOD varied across assays and centers underlining heterogeneous sensitivities: AltoStar had the lowest 95 % LOD (3 IU/ml) followed by RealStar (10 [min-max: 3-316] IU/ml), Bosphore-on-InGenius (10 IU/ml), RoboGene (31 [3-316] IU/ml), Nuclear-Laser-Medicine (31 IU/ml) and EuroBioplex (100 [100-316] IU/ml). Moreover, 6 assays (RoboGene, EurobioPlex, RealStar, AltoStar, Nuclear-Laser-Medicine and In-house) showed <0.5 log10 IU/ml differences between expected and observed HDV-RNA for all dilutions while other assays had >1 log10 IU/ml underestimations. RealStar, Bosphore-on-InGenius and EurobioPlex had the highest precision (mean intra-run CV < 20 %). Inter-run CV was higher for all assays, with CVs < 25 % for RealStar, AltoStar, Nuclear-Laser-Medicine and EurobioPlex. Seven assays (RoboGene/AltoStar/RealStar/EurobioPlex/Nuclear-Laser-Medicine/In-house) showed a good linearity (R2 > 0.90), but for HDV-RNA < 1000 IU/ml only Bosphore-on-InGenius, AltoStar, RealStar and Robogene showed a R2 > 0.85.
Conclusions: This study underlines heterogeneous sensitivities (inter- and intraassays), that could hamper proper HDV-RNA quantification, particularly at low viral loads. This raises the need to improve the diagnostic performance of most assays for properly identifying virological response to anti-HDV drugs.
期刊介绍：
The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice.
The journal publishes on topics that include:
• new diagnostic technologies
• nucleic acid amplification and serologic testing
• targeted and metagenomic next-generation sequencing
• emerging pandemic viral threats
• respiratory viruses
• transplant viruses
• chronic viral infections
• cancer-associated viruses
• gastrointestinal viruses
• central nervous system viruses
• one health (excludes animal health)
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