Comparison of diagnostic performances of HDV-RNA quantification assays used in clinical practice: Results from a national quality control multicenter study.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
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, HCV Virology Italian Resistance Network (VIRONET-C), 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
Аннотация
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.