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...

Celý popis

Uloženo v:

Podrobná bibliografie
Vydáno v:	Journal of clinical virology Ročník 180; s. 105850
Hlavní autoři:	Salpini, Romina, Piermatteo, Lorenzo, Caviglia, Gian Paolo, Bertoli, Ada, Brunetto, Maurizia Rossana, Bruzzone, Bianca, Callegaro, Annapaola, Caudai, Cinzia, Cavallone, Daniela, Chessa, Luchino, Coghe, Fernando, Coppola, Nicola, Cuomo, Nunzia, D'Anna, Stefano, Di Stefano, Mariantonietta, Facchetti, Floriana, Farina, Claudio, Ferraro, Donatella, Franchin, Elisa, Francisci, Daniela, Galli, Silvia, Garbuglia, Anna Rosa, Gennari, William, Ghisetti, Valeria, Lampertico, Pietro, Lo Caputo, Sergio, Marascio, Nadia, Menzo, Stefano, Micheli, Valeria, Niro, Grazia Anna, Olivero, Antonella, Paba, Pierpaolo, Palermo, Concetta Ilenia, Palmieri, Orazio, Paolucci, Stefania, Pisaturo, Mariantonietta, Pollicino, Teresa, Raffa, Giuseppina, Santantonio, Teresa, Torre, Giulia, Turriziani, Ombretta, Uzzau, Sergio, Uceda Renteria, Sara Colonia, Vatteroni, Marialinda, Zazzi, Maurizio, Craxì, Antonio, Ceccherini-Silberstein, Francesca, Svicher, Valentina, Arosio, Marco, Bastianelli, Sabrina, Gentile, Annamaria, Giardina, Federica A.M., Gidari, Anna, Govoni, Rosalba, Ibba, Gabriele, Loglio, Alessandro, Lombardi, Alessandra, Mascarella, Chiara, Maggi, Fabrizio, Matera, Giovanni, Mazzei, Chiara, Milia, Maria Grazia, Quirino, Angela, Raddi, Adriana, Scioscia, Rosetta, Tagliazucchi, Sara, Totaro, Michele, Valaperta, Rea
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	Netherlands Elsevier B.V 01.10.2025
Témata:	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 HDV-RNA Hepatitis D Real-Time PCR
ISSN:	1386-6532, 1873-5967, 1873-5967
On-line přístup:	Získat plný text
Tagy:	Přidat tag Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!

Popis
Shrnutí:	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.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1386-6532 1873-5967 1873-5967
DOI:	10.1016/j.jcv.2025.105850