Comparison of diagnostic performances of HDV-RNA quantification assays used in clinical practice: Results from a national quality control multicenter study
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. Two HDV-RNA sample panels were quantified in...
Saved in:
| Published in: | Journal of clinical virology Vol. 180; p. 105850 |
|---|---|
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Netherlands
Elsevier B.V
01.10.2025
|
| Subjects: | |
| ISSN: | 1386-6532, 1873-5967, 1873-5967 |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Abstract | 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.
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.
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.
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.
●The assays for HDV-RNA quantification need to optimize the performances at low HDV-RNA concentrations.●The laboratories should mitigate inter-laboratory and inter-assay variability by standardizing procedures and by favouring automation.●The use of sensitive assays is important for the proper monitoring of virological response to anti-HDV drugs and for optimizing therapeutical approaches aimed at setting-up a finite course of anti-HDV treatment. |
|---|---|
| AbstractList | 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.
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.
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.
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.
●The assays for HDV-RNA quantification need to optimize the performances at low HDV-RNA concentrations.●The laboratories should mitigate inter-laboratory and inter-assay variability by standardizing procedures and by favouring automation.●The use of sensitive assays is important for the proper monitoring of virological response to anti-HDV drugs and for optimizing therapeutical approaches aimed at setting-up a finite course of anti-HDV treatment. 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. 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. 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 > 0.90), but for HDV-RNA < 1000 IU/ml only Bosphore-on-InGenius, AltoStar, RealStar and Robogene showed a R > 0.85. 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. 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.INTRODUCTIONA 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.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.METHODSTwo 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.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.RESULTS95 % 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.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.CONCLUSIONSThis 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. |
| ArticleNumber | 105850 |
| Author | Ceccherini-Silberstein, Francesca Salpini, Romina Piermatteo, Lorenzo Caviglia, Gian Paolo Lo Caputo, Sergio Totaro, Michele Matera, Giovanni Brunetto, Maurizia Rossana Olivero, Antonella Coppola, Nicola Zazzi, Maurizio Bastianelli, Sabrina D'Anna, Stefano Scioscia, Rosetta Lampertico, Pietro Cavallone, Daniela Gentile, Annamaria Valaperta, Rea Paolucci, Stefania Menzo, Stefano Palmieri, Orazio Ibba, Gabriele Lombardi, Alessandra Franchin, Elisa Niro, Grazia Anna Mazzei, Chiara Francisci, Daniela Chessa, Luchino Milia, Maria Grazia Micheli, Valeria Raffa, Giuseppina Callegaro, Annapaola Arosio, Marco Santantonio, Teresa Giardina, Federica A.M. Ferraro, Donatella Loglio, Alessandro Vatteroni, Marialinda Caudai, Cinzia Torre, Giulia Maggi, Fabrizio Quirino, Angela Uceda Renteria, Sara Colonia Gennari, William Di Stefano, Mariantonietta Farina, Claudio Coghe, Fernando Pollicino, Teresa Paba, Pierpaolo Palermo, Concetta Ilenia Turriziani, Ombretta Govoni, Rosalba Mascarella, Chiara Bruzzone, Bianca Uzzau, Sergio Bertoli, Ada Raddi, Adriana Cuomo |
| Author_xml | – sequence: 1 givenname: Romina surname: Salpini fullname: Salpini, Romina organization: Department of Biology, University of Rome "Tor Vergata", Rome, Italy – sequence: 2 givenname: Lorenzo surname: Piermatteo fullname: Piermatteo, Lorenzo organization: Department of Biology, University of Rome "Tor Vergata", Rome, Italy – sequence: 3 givenname: Gian Paolo surname: Caviglia fullname: Caviglia, Gian Paolo organization: Department of Medical Sciences, University of Turin, Turin, Italy – sequence: 4 givenname: Ada surname: Bertoli fullname: Bertoli, Ada organization: Department of Experimental Medicine, University of Rome "Tor Vergata", Rome, Italy – sequence: 5 givenname: Maurizia Rossana surname: Brunetto fullname: Brunetto, Maurizia Rossana organization: Dept of Clinical and Experimental Medicine, University of Pisa and Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, Pisa University Hospital, Italy – sequence: 6 givenname: Bianca surname: Bruzzone fullname: Bruzzone, Bianca organization: Department of Health Sciences, University of Genoa, Genoa, Italy – sequence: 7 givenname: Annapaola surname: Callegaro fullname: Callegaro, Annapaola organization: Microbiology and Virology Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy – sequence: 8 givenname: Cinzia surname: Caudai fullname: Caudai, Cinzia organization: Microbiology and Virology Unit, Siena University Hospital, Siena, Italy – sequence: 9 givenname: Daniela surname: Cavallone fullname: Cavallone, Daniela organization: Dept of Clinical and Experimental Medicine, University of Pisa and Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, Pisa University Hospital, Italy – sequence: 10 givenname: Luchino surname: Chessa fullname: Chessa, Luchino organization: Department of Medical Sciences and Public Health, University of Cagliari, Liver Unit, University Hospital of Cagliari, Cagliari, Italy – sequence: 11 givenname: Fernando surname: Coghe fullname: Coghe, Fernando organization: Laboratory Clinical Chemical Analysis and Microbiology, University Hospital of Cagliari, Cagliari, Italy – sequence: 12 givenname: Nicola surname: Coppola fullname: Coppola, Nicola organization: Department of Mental Health and Public Medicine, Section of Infectious Diseases, University of Campania Luigi Vanvitelli, Caserta, Italy – sequence: 13 givenname: Nunzia surname: Cuomo fullname: Cuomo, Nunzia organization: Microbiology and Virology Unit, Domenico Cotugno Hospital, Naples, Italy – sequence: 14 givenname: Stefano surname: D'Anna fullname: D'Anna, Stefano organization: Department of Biology, University of Rome "Tor Vergata", Rome, Italy – sequence: 15 givenname: Mariantonietta surname: Di Stefano fullname: Di Stefano, Mariantonietta organization: Clinical and Surgical Sciences, Section of Infectious Diseases, University Hospital "Riuniti" of Foggia, Foggia, Italy – sequence: 16 givenname: Floriana surname: Facchetti fullname: Facchetti, Floriana organization: Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy – sequence: 17 givenname: Claudio surname: Farina fullname: Farina, Claudio organization: SC Clinical Microbiology and Virology, ASST "Papa Giovanni XXIII", Bergamo, Italy – sequence: 18 givenname: Donatella surname: Ferraro fullname: Ferraro, Donatella organization: Section of Microbiology and Clinical Microbiology, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, Palermo, Italy – sequence: 19 givenname: Elisa surname: Franchin fullname: Franchin, Elisa organization: Department of Molecular Medicine, University of Padova, Padova, Italy – sequence: 20 givenname: Daniela surname: Francisci fullname: Francisci, Daniela organization: Infectious Diseases Laboratory, Santa Maria della Misericordia Hospital, Perugia, Italy – sequence: 21 givenname: Silvia surname: Galli fullname: Galli, Silvia organization: Operative Unit of Clinical Microbiology, IRCCS S. Orsola-Malpighi University Hospital, Bologna, Italy – sequence: 22 givenname: Anna Rosa surname: Garbuglia fullname: Garbuglia, Anna Rosa organization: Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, IRCCS, Rome, Italy – sequence: 23 givenname: William surname: Gennari fullname: Gennari, William organization: Molecular Microbiology and Virology Unit, Department of Laboratory Medicine and Pathological Anatomy, Azienda Ospedaliero Universitaria di Modena, Modena, Italy – sequence: 24 givenname: Valeria surname: Ghisetti fullname: Ghisetti, Valeria organization: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, ASL Città di Torino, Turin, Italy – sequence: 25 givenname: Pietro surname: Lampertico fullname: Lampertico, Pietro organization: Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy – sequence: 26 givenname: Sergio surname: Lo Caputo fullname: Lo Caputo, Sergio organization: Clinical and Surgical Sciences, Section of Infectious Diseases, University Hospital "Riuniti" of Foggia, Foggia, Italy – sequence: 27 givenname: Nadia surname: Marascio fullname: Marascio, Nadia organization: Unit of Clinical Microbiology, Department of Health Sciences, "Magna Græcia" University, Catanzaro, Italy – sequence: 28 givenname: Stefano surname: Menzo fullname: Menzo, Stefano organization: Department of Biomedical Sciences and Public Health, Università Politecnica Delle Marche, Ancona, Italy – sequence: 29 givenname: Valeria surname: Micheli fullname: Micheli, Valeria organization: Laboratory of Clinical Microbiology, Virology and Bioemergencies, Ospedale Sacco, Milan, Italy – sequence: 30 givenname: Grazia Anna surname: Niro fullname: Niro, Grazia Anna organization: Division of Gastroenterology and Endoscopy, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy – sequence: 31 givenname: Antonella surname: Olivero fullname: Olivero, Antonella organization: Department of Medical Sciences, University of Turin, Turin, Italy – sequence: 32 givenname: Pierpaolo surname: Paba fullname: Paba, Pierpaolo organization: Unit of Virology, Tor Vergata Polyclinic Foundation, Tor Vergata University, Rome, Italy – sequence: 33 givenname: Concetta Ilenia surname: Palermo fullname: Palermo, Concetta Ilenia organization: Policlinico Universitario "Gaspare Rodolico", Catania, Italy – sequence: 34 givenname: Orazio surname: Palmieri fullname: Palmieri, Orazio organization: Division of Gastroenterology and Endoscopy, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy – sequence: 35 givenname: Stefania surname: Paolucci fullname: Paolucci, Stefania organization: Microbiology and Virology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy – sequence: 36 givenname: Mariantonietta surname: Pisaturo fullname: Pisaturo, Mariantonietta organization: Department of Mental Health and Public Medicine, Section of Infectious Diseases, University of Campania Luigi Vanvitelli, Caserta, Italy – sequence: 37 givenname: Teresa surname: Pollicino fullname: Pollicino, Teresa organization: Department of Clinical and Experimental Medicine, University Hospital "G. Martino" Messina, Messina, Italy – sequence: 38 givenname: Giuseppina surname: Raffa fullname: Raffa, Giuseppina organization: Department of Clinical and Experimental Medicine, University Hospital "G. Martino" Messina, Messina, Italy – sequence: 39 givenname: Teresa surname: Santantonio fullname: Santantonio, Teresa organization: Clinical and Surgical Sciences, Section of Infectious Diseases, University Hospital "Riuniti" of Foggia, Foggia, Italy – sequence: 40 givenname: Giulia surname: Torre fullname: Torre, Giulia organization: Department of Biology, University of Rome "Tor Vergata", Rome, Italy – sequence: 41 givenname: Ombretta surname: Turriziani fullname: Turriziani, Ombretta organization: Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy – sequence: 42 givenname: Sergio surname: Uzzau fullname: Uzzau, Sergio organization: Department of Biomedical Sciences, University of Sassari, Sassari, Italy – sequence: 43 givenname: Sara Colonia surname: Uceda Renteria fullname: Uceda Renteria, Sara Colonia organization: Microbiology and Virology Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy – sequence: 44 givenname: Marialinda surname: Vatteroni fullname: Vatteroni, Marialinda organization: Virology Unit, Pisa University Hospital, Pisa, Italy – sequence: 45 givenname: Maurizio surname: Zazzi fullname: Zazzi, Maurizio organization: Department of Medical Biotechnology, University of Siena, Siena, Italy – sequence: 46 givenname: Antonio surname: Craxì fullname: Craxì, Antonio organization: Section of Microbiology and Clinical Microbiology, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, Palermo, Italy – sequence: 47 givenname: Francesca surname: Ceccherini-Silberstein fullname: Ceccherini-Silberstein, Francesca organization: Department of Experimental Medicine, University of Rome "Tor Vergata", Rome, Italy – sequence: 48 givenname: Valentina surname: Svicher fullname: Svicher, Valentina email: valentina.svicher@uniroma2.it organization: Department of Biology, University of Rome "Tor Vergata", Rome, Italy – sequence: 49 givenname: Marco surname: Arosio fullname: Arosio, Marco organization: SC Clinical Microbiology and Virology, ASST "Papa Giovanni XXIII", Bergamo, Italy – sequence: 50 givenname: Sabrina surname: Bastianelli fullname: Bastianelli, Sabrina organization: Infectious Diseases Laboratory, Santa Maria della Misericordia Hospital, Perugia, Italy – sequence: 51 givenname: Annamaria surname: Gentile fullname: Gentile, Annamaria organization: Division of Gastroenterology and Endoscopy, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy – sequence: 52 givenname: Federica A.M. surname: Giardina fullname: Giardina, Federica A.M. organization: Microbiology and Virology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy – sequence: 53 givenname: Anna surname: Gidari fullname: Gidari, Anna organization: Infectious Diseases Laboratory, Santa Maria della Misericordia Hospital, Perugia, Italy – sequence: 54 givenname: Rosalba surname: Govoni fullname: Govoni, Rosalba organization: Department of Biomedical Sciences, University of Sassari, Sassari, Italy – sequence: 55 givenname: Gabriele surname: Ibba fullname: Ibba, Gabriele organization: Department of Biomedical Sciences, University of Sassari, Sassari, Italy – sequence: 56 givenname: Alessandro surname: Loglio fullname: Loglio, Alessandro organization: SC Clinical Microbiology and Virology, ASST "Papa Giovanni XXIII", Bergamo, Italy – sequence: 57 givenname: Alessandra surname: Lombardi fullname: Lombardi, Alessandra organization: Laboratory of Clinical Microbiology, Virology and Bioemergencies, Ospedale Sacco, Milan, Italy – sequence: 58 givenname: Chiara surname: Mascarella fullname: Mascarella, Chiara organization: Section of Microbiology and Clinical Microbiology, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, Palermo, Italy – sequence: 59 givenname: Fabrizio surname: Maggi fullname: Maggi, Fabrizio organization: Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, IRCCS, Rome, Italy – sequence: 60 givenname: Giovanni surname: Matera fullname: Matera, Giovanni organization: Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, IRCCS, Rome, Italy – sequence: 61 givenname: Chiara surname: Mazzei fullname: Mazzei, Chiara organization: Unit of Clinical Microbiology, Department of Health Sciences, "Magna Græcia" University, Catanzaro, Italy – sequence: 62 givenname: Maria Grazia surname: Milia fullname: Milia, Maria Grazia organization: Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, IRCCS, Rome, Italy – sequence: 63 givenname: Angela surname: Quirino fullname: Quirino, Angela organization: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, ASL Città di Torino, Turin, Italy – sequence: 64 givenname: Adriana surname: Raddi fullname: Raddi, Adriana organization: Microbiology and Virology Unit, Domenico Cotugno Hospital, Naples, Italy – sequence: 65 givenname: Rosetta surname: Scioscia fullname: Scioscia, Rosetta organization: Department of Medical Sciences and Public Health, University of Cagliari, Liver Unit, University Hospital of Cagliari, Cagliari, Italy – sequence: 66 givenname: Sara surname: Tagliazucchi fullname: Tagliazucchi, Sara organization: Molecular Microbiology and Virology Unit, Department of Laboratory Medicine and Pathological Anatomy, Azienda Ospedaliero Universitaria di Modena, Modena, Italy – sequence: 67 givenname: Michele surname: Totaro fullname: Totaro, Michele organization: SC Clinical Microbiology and Virology, ASST "Papa Giovanni XXIII", Bergamo, Italy – sequence: 68 givenname: Rea surname: Valaperta fullname: Valaperta, Rea organization: Medicina di Laboratorio, ASST Bergamo Est, Bergamo, Italy |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40784197$$D View this record in MEDLINE/PubMed |
| BookMark | eNqFkc1u1DAURi1URH_gAdggL9lksOPEjmFVTYEiVSBVwNZynGvkIbFT26mUZ-Fl8XRaFl2Ula91z7mL7ztFRz54QOg1JRtKKH-32-zM7aYmdVv-bdeSZ-iEdoJVreTiqMys4xVvWX2MTlPaEUJb1ogX6LghomuoFCfozzZMs44uBY-DxYPTv3xI2Rk8Q7QhTtobSPvV5cXP6vrrOb5ZtM_OOqOzK5JOSa8JLwkG7Dw2o_NlNeI5alPOwHt8DWkZc8I2hglr7O-8QpRDo8srNsHnGEY8FaoIPkPEKS_D-hI9t3pM8Or-PUM_Pn38vr2srr59_rI9v6pM03S5GmzdQ9N3RDaGUwOSMcKBt1Ya6JiwUtcUjOBgGTGi0LXmrO0F6SmxXAp2ht4e7s4x3CyQsppcMjCO2kNYkmI165paNi0t6Jt7dOknGNQc3aTjqh4CLQA9ACaGlCLYfwglal-a2qlSmtqXpg6lFUc8cozLdynlqN34pPnhYEKJ59ZBVMk4KI0NLoLJagjuSVs-sh_a-w3rf9y_RhDHOw |
| CitedBy_id | crossref_primary_10_3390_v17091220 |
| Cites_doi | 10.1016/j.jhep.2023.05.001 10.3390/biomedicines10040792 10.1111/liv.15795 10.1016/j.jhep.2017.03.021 10.1002/hep.28772 10.3389/fcimb.2024.1422299 10.1016/j.jcv.2021.104932 10.1016/S1473-3099(22)00318-8 10.1016/S0168-8278(25)00381-2 10.1136/gut.46.3.420 10.1016/j.jviromet.2019.113715 10.1111/liv.15410 10.1111/apt.16485 10.1016/j.jhep.2023.10.043 10.1136/gutjnl-2020-323888 10.1016/j.jhep.2020.06.038 10.1016/j.dld.2022.11.003 10.1056/NEJMoa2213429 10.1016/j.ijid.2023.11.005 10.1097/HEP.0000000000000642 |
| ContentType | Journal Article |
| Copyright | 2025 The Authors Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved. |
| Copyright_xml | – notice: 2025 The Authors – notice: Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved. |
| CorporateAuthor | HCV Virology Italian Resistance Network (VIRONET-C) |
| CorporateAuthor_xml | – name: HCV Virology Italian Resistance Network (VIRONET-C) |
| DBID | 6I. AAFTH AAYXX CITATION CGR CUY CVF ECM EIF NPM 7X8 |
| DOI | 10.1016/j.jcv.2025.105850 |
| DatabaseName | ScienceDirect Open Access Titles Elsevier:ScienceDirect:Open Access CrossRef Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed MEDLINE - Academic |
| DatabaseTitle | CrossRef MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) MEDLINE - Academic |
| DatabaseTitleList | MEDLINE MEDLINE - Academic |
| Database_xml | – sequence: 1 dbid: NPM name: PubMed url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: 7X8 name: MEDLINE - Academic url: https://search.proquest.com/medline sourceTypes: Aggregation Database |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Biology |
| EISSN | 1873-5967 |
| ExternalDocumentID | 40784197 10_1016_j_jcv_2025_105850 S1386653225000927 |
| Genre | Multicenter Study Journal Article Comparative Study |
| GroupedDBID | --- --K --M .1- .FO .GJ .~1 0R~ 1B1 1P~ 1RT 1~. 1~5 29K 4.4 457 4CK 4G. 53G 5GY 5VS 7-5 71M 8P~ AAAJQ AABNK AAEDT AAEDW AAIKJ AAKOC AALRI AAOAW AAQFI AAQXK AARKO AATTM AAXKI AAXUO AAYWO ABBQC ABFNM ABFRF ABJNI ABMAC ABMZM ABWVN ABXDB ACDAQ ACGFO ACGFS ACIEU ACIUM ACLOT ACRLP ACRPL ACVFH ADBBV ADCNI ADEZE ADMUD ADNMO ADVLN AEBSH AEFWE AEIPS AEKER AENEX AEUPX AEVXI AFJKZ AFPUW AFRHN AFTJW AFXIZ AGEKW AGHFR AGQPQ AGUBO AGYEJ AIEXJ AIGII AIIUN AIKHN AITUG AJRQY AJUYK AKBMS AKRWK AKYEP ALMA_UNASSIGNED_HOLDINGS AMRAJ ANKPU ANZVX APXCP ASPBG AVWKF AXJTR AZFZN BKOJK BLXMC BNPGV CJTIS CS3 D-I DU5 EBS EFJIC EFKBS EFLBG EJD EO8 EO9 EP2 EP3 F5P FDB FEDTE FGOYB FIRID FNPLU FYGXN G-Q GBLVA HVGLF HX~ HZ~ IHE J1W KOM LUGTX M41 MO0 N9A O-L O9- OAUVE OD- OO. OZT P-8 P-9 P2P PC. Q38 R2- ROL RPZ SCC SDF SDG SDP SEL SES SEW SPCBC SSH SSI SSZ T5K UNMZH Z5R ~G- ~HD 6I. AAFTH 9DU AAYXX CITATION AGCQF CGR CUY CVF ECM EIF NPM 7X8 |
| ID | FETCH-LOGICAL-c448t-df2be4b8094c61ce93306e65f9ce837f9a21ec76ef30c7df22a635b70b10f6973 |
| ISICitedReferencesCount | 2 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=001583952700002&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 1386-6532 1873-5967 |
| IngestDate | Thu Oct 02 21:53:56 EDT 2025 Wed Sep 10 03:23:12 EDT 2025 Tue Nov 18 21:09:00 EST 2025 Sat Nov 29 06:52:05 EST 2025 Sat Oct 04 17:00:38 EDT 2025 Sat Oct 11 07:35:16 EDT 2025 |
| IsDoiOpenAccess | true |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Keywords | HDV-RNA Hepatitis D Real-Time PCR |
| Language | English |
| License | This is an open access article under the CC BY license. Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved. |
| LinkModel | OpenURL |
| MergedId | FETCHMERGED-LOGICAL-c448t-df2be4b8094c61ce93306e65f9ce837f9a21ec76ef30c7df22a635b70b10f6973 |
| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
| OpenAccessLink | https://www.clinicalkey.com/#!/content/1-s2.0-S1386653225000927 |
| PMID | 40784197 |
| PQID | 3238429451 |
| PQPubID | 23479 |
| ParticipantIDs | proquest_miscellaneous_3238429451 pubmed_primary_40784197 crossref_primary_10_1016_j_jcv_2025_105850 crossref_citationtrail_10_1016_j_jcv_2025_105850 elsevier_sciencedirect_doi_10_1016_j_jcv_2025_105850 elsevier_clinicalkey_doi_10_1016_j_jcv_2025_105850 |
| PublicationCentury | 2000 |
| PublicationDate | 2025-10-01 |
| PublicationDateYYYYMMDD | 2025-10-01 |
| PublicationDate_xml | – month: 10 year: 2025 text: 2025-10-01 day: 01 |
| PublicationDecade | 2020 |
| PublicationPlace | Netherlands |
| PublicationPlace_xml | – name: Netherlands |
| PublicationTitle | Journal of clinical virology |
| PublicationTitleAlternate | J Clin Virol |
| PublicationYear | 2025 |
| Publisher | Elsevier B.V |
| Publisher_xml | – name: Elsevier B.V |
| References | Le Gal, Brichler, Sahli, Chevret, Gordien (bib8) 2016; 64 Razavi-Shearer, Child, Razavi-Shearer, Voeller, Razavi, Buti, Tacke, Terrault, Zeuzem, Abbas, Aghemo, Akarca, Al Masri, Alalwan, Blomé, Jerkeman, Aleman, Kamal, Alghamdi, Alghamdi, Alghamdi, Al-Hamoudi, Ali, Aljumah, Altraif, Amarsanaa, Asselah, Baatarkhuu, Babameto, Ben-Ari, Berg, Biondi, Braga, Brandão-Mello, Brown, Brunetto, Cabezas, Cardoso, Martins, Chan, Cheinquer, Chen, Yang, Chen, Chien, Chuang, Garza, Coco, Coffin, Coppola, Cornberg, Craxi, Crespo, Cuko, De Ledinghen, Duberg, Etzion, Ferraz, Ferreira, Forns, Foster, Fung, Gaeta, García-Samaniego, Genov, Gheorghe, Gholam, Gish, Glenn, Hamid, Hercun, Hsu, Hu, Huang, Idilman, Jafri, Janjua, Jelev, Jia, Kåberg, Kaita, Kao, Khan, Kim, Kondili, Lagging, Lampertico, Lázaro, Lazarus, Lee, Lim, Lobato, Macedo, Marinho, Marotta, Mendes-Correa, Méndez-Sánchez, Navas, Ning, Örmeci, Orrego, Osiowy, Pan, Pessoa, Piracha, Pop, Qureshi, Raimondo, Ramji, Ribeiro, Ríos-Hincapié, Rodríguez, Rosenberg, Roulot, Ryder, Saeed, Safadi, Shouval, Sanai, Sanchez-Avila, Santantonio, Sarrazin, Seto, Simonova, Tanaka, Tergast, Tsendsuren, Valente, Villalobos-Salcedo, Waheed, Wong, Wong, Yip, Wu, Yu, Yuen, Yurdaydin, Zuckerman (bib19) 2024; 80 Roulot, Brichler, Layese, BenAbdesselam, Zoulim, Thibault, Scholtes, Roche, Castelnau, Poynard, Chazouillères, Ganne, Fontaine, Gournay, Guyader, Le Gal, Nahon, Roudot-Thoraval, Gordien, Grangé, Landman, Hezode, Riachi, Lascoux-Combe, Loustaud-Ratti, Rosa, Mathurin, Nguyen-Khac, Causse, Naveau, Habersetzer, Metivier, Labadie, Sellier, Bottero, de Ledinghen, Alric, Calès, Goujard, Cadranel, Salmon, Hillaire (bib6) 2020; 73 Sandmann, Wedemeyer (bib21) 2023; 43 Urban, Neumann-Haefelin, Lampertico (bib1) 2021; 70 Pauly, Kamili, Hayden (bib14) 2019; 273 Lampertico, Agarwal, Berg, Buti, Janssen, Papatheodoridis, Zoulim, Tacke (bib3) 2017; 67 Aleman, Brunetto, Blank, Andreone, Bogomolov, Chulanov, Mamonova, Geyvandova, Morozov, Sagalova, Stepanova, Lichtman, Mercier, Manuilov, Arterburn, Wiesch, Cornberg, Zeuzem, Lampertico, Wedemeyer (bib20) 2025 Fattovich (bib2) 2000; 46 Palom, Sopena, Riveiro‐Barciela, Carvalho‐Gomes, Madejón, Rodriguez‐Tajes, Roade, García‐Eliz, García‐Samaniego, Lens, Berenguer‐Hayme, Rodríguez‐Frías, Hernandez‐Évole, Isabel Gil‐García, Barreira, Esteban, Buti (bib5) 2021; 54 Olivero, Rosso, Ciancio, Abate, Nicolosi, Troshina, Armandi, Ribaldone, Saracco, Bugianesi, Rizzetto, Caviglia (bib12) 2022; 10 Salpini, Piermatteo, Torre, D’Anna, Khan, Duca, Bertoli, La Frazia, Malagnino, Teti, Iannetta, Paba, Ciotti, Lenci, Francioso, Paquazzi, Lichtner, Mastroianni, Santopaolo, De Sanctis, Pellicelli, Galati, Moretti, Casinelli, Caterini, Iapadre, Parruti, Vecchiet, Paoloni, Marignani, Ceccherini-Silberstein, Baiocchi, Grelli, Sarmati, Svicher (bib17) 2024; 138 Stelzl, Ciesek, Cornberg, Maasoumy, Heim, Chudy, Olivero, Miklau, Nickel, Reinhardt, Dietzsch, Kessler (bib13) 2021; 142 Gish, Wong, Di Tanna, Kaushik, Kim, Smith, Kennedy (bib7) 2024; 79 Wedemeyer, Schöneweis, Bogomolov, Blank, Voronkova, Stepanova, Sagalova, Chulanov, Osipenko, Morozov, Geyvandova, Sleptsova, Bakulin, Khaertynova, Rusanova, Pathil, Merle, Bremer, Allweiss, Lempp, Port, Haag, Schwab, zur Wiesch, Cornberg, Haefeli, Dandri, Alexandrov, Urban (bib11) 2023; 23 Anolli, Renteria, Degasperi, Borghi, Facchetti, Sambarino, Perbellini, Monico, Ceriotti, Lampertico (bib16) 2024; 44 Illescas-López, Chaves-Blanco, de Salazar, Hernández-Febles, Carracedo, Lagarejos, Fuentes, Pereira, Cea, De La Iglesia, Freyre, Iborra, Odero, García-Barrionuevo, Aguilera, Pena, García (bib9) 2024; 14 Wedemeyer, Aleman, Brunetto, Blank, Andreone, Bogomolov, Chulanov, Mamonova, Geyvandova, Morozov, Sagalova, Stepanova, Berger, Manuilov, Suri, An, Da, Flaherty, Osinusi, Liu, Merle, Schulze zur Wiesch, Zeuzem, Ciesek, Cornberg, Lampertico (bib10) 2023; 389 Brunetto, Ricco, Negro, Wedemeyer, Yurdaydin, Asselah, Papatheodoridis, Gheorghe, Agarwal, Farci, Buti (bib4) 2023 Anolli, Uceda Renteria, Degasperi, Facchetti, Sambarino, Borghi, Perbellini, Soffredini, Monico, Callegaro, Lampertico (bib15) 2025; 7 Ricco, Coco, Colombatto, Oliveri, Cavallone, Bleve, Vianello, Romagnoli, Salvati, Surace, Bonino, Brunetto (bib18) 2023; 55 Wedemeyer (10.1016/j.jcv.2025.105850_bib10) 2023; 389 Le Gal (10.1016/j.jcv.2025.105850_bib8) 2016; 64 Roulot (10.1016/j.jcv.2025.105850_bib6) 2020; 73 Olivero (10.1016/j.jcv.2025.105850_bib12) 2022; 10 Stelzl (10.1016/j.jcv.2025.105850_bib13) 2021; 142 Razavi-Shearer (10.1016/j.jcv.2025.105850_bib19) 2024; 80 Lampertico (10.1016/j.jcv.2025.105850_bib3) 2017; 67 Gish (10.1016/j.jcv.2025.105850_bib7) 2024; 79 Aleman (10.1016/j.jcv.2025.105850_bib20) 2025 Fattovich (10.1016/j.jcv.2025.105850_bib2) 2000; 46 Wedemeyer (10.1016/j.jcv.2025.105850_bib11) 2023; 23 Pauly (10.1016/j.jcv.2025.105850_bib14) 2019; 273 Illescas-López (10.1016/j.jcv.2025.105850_bib9) 2024; 14 Anolli (10.1016/j.jcv.2025.105850_bib16) 2024; 44 Salpini (10.1016/j.jcv.2025.105850_bib17) 2024; 138 Palom (10.1016/j.jcv.2025.105850_bib5) 2021; 54 Sandmann (10.1016/j.jcv.2025.105850_bib21) 2023; 43 Anolli (10.1016/j.jcv.2025.105850_bib15) 2025; 7 Ricco (10.1016/j.jcv.2025.105850_bib18) 2023; 55 Brunetto (10.1016/j.jcv.2025.105850_bib4) 2023 Urban (10.1016/j.jcv.2025.105850_bib1) 2021; 70 |
| References_xml | – volume: 14 year: 2024 ident: bib9 article-title: Assessment of performance and comparison of three commercial HDV RNA detection assays: implications for diagnosis and treatment monitoring publication-title: Front. Cell. Infect. Microbiol. – volume: 389 start-page: 22 year: 2023 end-page: 32 ident: bib10 article-title: A phase 3, randomized trial of bulevirtide in chronic hepatitis D publication-title: N. Engl. J. Med. – volume: 138 start-page: 1 year: 2024 end-page: 9 ident: bib17 article-title: Prevalence of hepatitis D virus infection in central Italy has remained stable across the last 2 decades with dominance of subgenotypes 1 and characterized by elevated viral replication publication-title: Int. J. Infect. Dis. – volume: 142 year: 2021 ident: bib13 article-title: Reliable quantification of plasma HDV RNA is of paramount importance for treatment monitoring: a European multicenter study publication-title: J. Clin. Virol. – volume: 54 start-page: 462 year: 2021 end-page: 469 ident: bib5 article-title: One‐quarter of chronic hepatitis D patients reach HDV‐RNA decline or undetectability during the natural course of the disease publication-title: Aliment. Pharmacol. Ther. – volume: 67 start-page: 370 year: 2017 end-page: 398 ident: bib3 article-title: EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection publication-title: J. Hepatol. – volume: 73 start-page: 1046 year: 2020 end-page: 1062 ident: bib6 article-title: Origin, HDV genotype and persistent viremia determine outcome and treatment response in patients with chronic hepatitis delta publication-title: J. Hepatol. – volume: 10 start-page: 792 year: 2022 ident: bib12 article-title: Clinical application of droplet digital PCR for hepatitis delta virus quantification publication-title: Biomedicines – volume: 70 start-page: 1782 year: 2021 end-page: 1794 ident: bib1 article-title: Hepatitis D virus in 2021: virology, immunology and new treatment approaches for a difficult-to-treat disease publication-title: Gut – volume: 80 start-page: 232 year: 2024 end-page: 242 ident: bib19 article-title: Adjusted estimate of the prevalence of hepatitis delta virus in 25 countries and territories publication-title: J. Hepatol. – volume: 44 start-page: 831 year: 2024 end-page: 837 ident: bib16 article-title: Quantification of serum HDV RNA by robogene 2.0 in HDV patients is significantly influenced by the extraction methods publication-title: Liver Int. – year: 2023 ident: bib4 article-title: EASL clinical practice guidelines on hepatitis delta virus publication-title: J. Hepatol. – volume: 64 start-page: 1483 year: 2016 end-page: 1494 ident: bib8 article-title: First international external quality assessment for hepatitis delta virus RNA quantification in plasma publication-title: Hepatology – volume: 43 start-page: 69 year: 2023 end-page: 79 ident: bib21 article-title: Interferon‐based treatment of chronic hepatitis D publication-title: Liver Int. – volume: 79 start-page: 1129 year: 2024 end-page: 1140 ident: bib7 article-title: Association of hepatitis delta virus with liver morbidity and mortality: a systematic literature review and meta-analysis publication-title: Hepatology – start-page: S48 year: 2025 end-page: S49 ident: bib20 article-title: OS-066 predictors of undetectable hepatitis delta virus RNA at 48 weeks after end of treatment with bulevirtide monotherapy in the MYR 301 study publication-title: J. Hepatol. – volume: 7 year: 2025 ident: bib15 article-title: Comparing methods for plasma HDV RNA quantification in bulevirtide-treated and untreated patients with HDV publication-title: JHEP Rep. – volume: 46 start-page: 420 year: 2000 end-page: 426 ident: bib2 article-title: Influence of hepatitis delta virus infection on morbidity and mortality in compensated cirrhosis type B publication-title: Gut – volume: 55 start-page: 519 year: 2023 end-page: 526 ident: bib18 article-title: Highly dynamic changes of regional HBV epidemiology over two decades publication-title: Dig. Liver Dis. – volume: 23 start-page: 117 year: 2023 end-page: 129 ident: bib11 article-title: Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomised, parallel-group, open-label, phase 2 trial publication-title: Lancet Infect. Dis. – volume: 273 year: 2019 ident: bib14 article-title: Impact of nucleic acid extraction platforms on hepatitis virus genome detection publication-title: J. Virol. Methods – year: 2023 ident: 10.1016/j.jcv.2025.105850_bib4 article-title: EASL clinical practice guidelines on hepatitis delta virus publication-title: J. Hepatol. doi: 10.1016/j.jhep.2023.05.001 – volume: 10 start-page: 792 year: 2022 ident: 10.1016/j.jcv.2025.105850_bib12 article-title: Clinical application of droplet digital PCR for hepatitis delta virus quantification publication-title: Biomedicines doi: 10.3390/biomedicines10040792 – volume: 44 start-page: 831 year: 2024 ident: 10.1016/j.jcv.2025.105850_bib16 article-title: Quantification of serum HDV RNA by robogene 2.0 in HDV patients is significantly influenced by the extraction methods publication-title: Liver Int. doi: 10.1111/liv.15795 – volume: 67 start-page: 370 year: 2017 ident: 10.1016/j.jcv.2025.105850_bib3 article-title: EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection publication-title: J. Hepatol. doi: 10.1016/j.jhep.2017.03.021 – volume: 64 start-page: 1483 year: 2016 ident: 10.1016/j.jcv.2025.105850_bib8 article-title: First international external quality assessment for hepatitis delta virus RNA quantification in plasma publication-title: Hepatology doi: 10.1002/hep.28772 – volume: 14 year: 2024 ident: 10.1016/j.jcv.2025.105850_bib9 article-title: Assessment of performance and comparison of three commercial HDV RNA detection assays: implications for diagnosis and treatment monitoring publication-title: Front. Cell. Infect. Microbiol. doi: 10.3389/fcimb.2024.1422299 – volume: 7 year: 2025 ident: 10.1016/j.jcv.2025.105850_bib15 article-title: Comparing methods for plasma HDV RNA quantification in bulevirtide-treated and untreated patients with HDV publication-title: JHEP Rep. – volume: 142 year: 2021 ident: 10.1016/j.jcv.2025.105850_bib13 article-title: Reliable quantification of plasma HDV RNA is of paramount importance for treatment monitoring: a European multicenter study publication-title: J. Clin. Virol. doi: 10.1016/j.jcv.2021.104932 – volume: 23 start-page: 117 year: 2023 ident: 10.1016/j.jcv.2025.105850_bib11 article-title: Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomised, parallel-group, open-label, phase 2 trial publication-title: Lancet Infect. Dis. doi: 10.1016/S1473-3099(22)00318-8 – start-page: S48 year: 2025 ident: 10.1016/j.jcv.2025.105850_bib20 article-title: OS-066 predictors of undetectable hepatitis delta virus RNA at 48 weeks after end of treatment with bulevirtide monotherapy in the MYR 301 study publication-title: J. Hepatol. doi: 10.1016/S0168-8278(25)00381-2 – volume: 46 start-page: 420 year: 2000 ident: 10.1016/j.jcv.2025.105850_bib2 article-title: Influence of hepatitis delta virus infection on morbidity and mortality in compensated cirrhosis type B publication-title: Gut doi: 10.1136/gut.46.3.420 – volume: 273 year: 2019 ident: 10.1016/j.jcv.2025.105850_bib14 article-title: Impact of nucleic acid extraction platforms on hepatitis virus genome detection publication-title: J. Virol. Methods doi: 10.1016/j.jviromet.2019.113715 – volume: 43 start-page: 69 year: 2023 ident: 10.1016/j.jcv.2025.105850_bib21 article-title: Interferon‐based treatment of chronic hepatitis D publication-title: Liver Int. doi: 10.1111/liv.15410 – volume: 54 start-page: 462 year: 2021 ident: 10.1016/j.jcv.2025.105850_bib5 article-title: One‐quarter of chronic hepatitis D patients reach HDV‐RNA decline or undetectability during the natural course of the disease publication-title: Aliment. Pharmacol. Ther. doi: 10.1111/apt.16485 – volume: 80 start-page: 232 year: 2024 ident: 10.1016/j.jcv.2025.105850_bib19 article-title: Adjusted estimate of the prevalence of hepatitis delta virus in 25 countries and territories publication-title: J. Hepatol. doi: 10.1016/j.jhep.2023.10.043 – volume: 70 start-page: 1782 year: 2021 ident: 10.1016/j.jcv.2025.105850_bib1 article-title: Hepatitis D virus in 2021: virology, immunology and new treatment approaches for a difficult-to-treat disease publication-title: Gut doi: 10.1136/gutjnl-2020-323888 – volume: 73 start-page: 1046 year: 2020 ident: 10.1016/j.jcv.2025.105850_bib6 article-title: Origin, HDV genotype and persistent viremia determine outcome and treatment response in patients with chronic hepatitis delta publication-title: J. Hepatol. doi: 10.1016/j.jhep.2020.06.038 – volume: 55 start-page: 519 year: 2023 ident: 10.1016/j.jcv.2025.105850_bib18 article-title: Highly dynamic changes of regional HBV epidemiology over two decades publication-title: Dig. Liver Dis. doi: 10.1016/j.dld.2022.11.003 – volume: 389 start-page: 22 year: 2023 ident: 10.1016/j.jcv.2025.105850_bib10 article-title: A phase 3, randomized trial of bulevirtide in chronic hepatitis D publication-title: N. Engl. J. Med. doi: 10.1056/NEJMoa2213429 – volume: 138 start-page: 1 year: 2024 ident: 10.1016/j.jcv.2025.105850_bib17 article-title: Prevalence of hepatitis D virus infection in central Italy has remained stable across the last 2 decades with dominance of subgenotypes 1 and characterized by elevated viral replication publication-title: Int. J. Infect. Dis. doi: 10.1016/j.ijid.2023.11.005 – volume: 79 start-page: 1129 year: 2024 ident: 10.1016/j.jcv.2025.105850_bib7 article-title: Association of hepatitis delta virus with liver morbidity and mortality: a systematic literature review and meta-analysis publication-title: Hepatology doi: 10.1097/HEP.0000000000000642 |
| SSID | ssj0015347 |
| Score | 2.4617682 |
| Snippet | A reliable quantification of hepatitis D virus (HDV) RNA is of paramount importance for monitoring patients under antiviral therapy. This quality control study... |
| SourceID | proquest pubmed crossref elsevier |
| SourceType | Aggregation Database Index Database Enrichment Source Publisher |
| StartPage | 105850 |
| SubjectTerms | HDV-RNA Hepatitis D Hepatitis D - diagnosis Hepatitis D - virology Hepatitis Delta Virus - genetics Hepatitis Delta Virus - isolation & purification Humans Molecular Diagnostic Techniques - methods Molecular Diagnostic Techniques - standards Quality Control Real-Time PCR Reproducibility of Results RNA, Viral - blood RNA, Viral - genetics Sensitivity and Specificity Viral Load - methods Viral Load - standards |
| Title | Comparison of diagnostic performances of HDV-RNA quantification assays used in clinical practice: Results from a national quality control multicenter study |
| URI | https://www.clinicalkey.com/#!/content/1-s2.0-S1386653225000927 https://dx.doi.org/10.1016/j.jcv.2025.105850 https://www.ncbi.nlm.nih.gov/pubmed/40784197 https://www.proquest.com/docview/3238429451 |
| Volume | 180 |
| WOSCitedRecordID | wos001583952700002&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| journalDatabaseRights | – providerCode: PRVESC databaseName: Elsevier SD Freedom Collection Journals 2021 customDbUrl: eissn: 1873-5967 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0015347 issn: 1386-6532 databaseCode: AIEXJ dateStart: 20161001 isFulltext: true titleUrlDefault: https://www.sciencedirect.com providerName: Elsevier |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwtV1bb9MwFLa6DSReENcxLpOREA9UqdLcHPNWjY6BqjKNbupb5LgOalWS0qbVyl_hJ_GnOI4v6Rgb44GXqHLsOM35cs7JuSL0qs2pF4qMOi6PmAMMz3eYx6hDUhAGIwLcsOrWcNYj_X48HNLjRuOnyYVZTUmex-fndPZfSQ1jQGyZOvsP5LYXhQH4DUSHI5Adjjci_MFmZ0FpW5WhdLIs66zOEajiN47enTkn_Y7Mq1QRQwoLoE2z9aK5XAhZlqlOnTT5VCqEbrGclguVnMKa1qKoUjTXNgC-CleU8Z-yZrQtZHtZF7abyKy7TTv_ZzadjauuU82T4qtu9V2x8rEUKWWpTL29Yi7y70XtUFmNv-gw4PeSgx0zuKq1PIh5Wais8I62R2izhxfaADrDqWPiOyFVvTxa4g9jlr27Gwwa1MlYVbq9JDuUGWPSmvBVS-7YquderNPd_5QcnvZ6yaA7HLyefXNkCzPp6tf9XLbQjkdCCix2p_OhO_xonVqhX_W7s3dpnOxVuOFvu16lJl31GVSpQ4N76K6mHe4o_N1HDZE_QLdVZ9P1Q_SjRiEuMlyjEG-iUJ7SKMQXUYgVCrFEIR7n2AAEGxS-xRqDWGIQM2wwiDUGscYg3sAgrjD4CJ0edgcHR47uA-LwIIhLZ5R5qQjS2KUBj9pcSBtcJKIwo1zEPsko89qCk0hkvssJzPYYqNEpcdO2m0WU-I_Rdl7k4gnCfsrDLAhZHPgiYDxjIvJGni88MhIcPpX2kGsee8J1kXzZq2WamGjISQKUSiSlEkWpPfTGLpmpCjHXTfYMLRPz5EBYJ4DB6xYFdpHWi5W--7dlLw1YEpAZ0hHIclEsF4kPejqw5SCE_7urUGRvXfr1gzYlT2-w-hm6U7-az9F2OV-KF-gWX5XjxXwfbZFhvK9fgl-eOfQy |
| linkProvider | Elsevier |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Comparison+of+diagnostic+performances+of+HDV-RNA+quantification+assays+used+in+clinical+practice%3A+Results+from+a+national+quality+control+multicenter+study&rft.jtitle=Journal+of+clinical+virology&rft.au=Salpini%2C+Romina&rft.au=Piermatteo%2C+Lorenzo&rft.au=Caviglia%2C+Gian+Paolo&rft.au=Bertoli%2C+Ada&rft.date=2025-10-01&rft.issn=1873-5967&rft.eissn=1873-5967&rft.volume=180&rft.spage=105850&rft_id=info:doi/10.1016%2Fj.jcv.2025.105850&rft.externalDBID=NO_FULL_TEXT |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1386-6532&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1386-6532&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1386-6532&client=summon |