PDF(Pubmed)
Abstract：
UNASSIGNED: Precise HDV-RNA detection and quantification are pivotal for diagnosis and monitoring of response to newly approved treatment. We evaluate the performance of three HDV RNA detection and quantification assays.
UNASSIGNED: Hepatitis Delta RT-PCR system kit, EurobioPlex HDV assay, and RoboGene HDV RNA Quantification kit 2.0 were used for testing 151 HBsAg-positive samples, 90 HDV-RNA negative and 61 HDV-RNA positive. We also evaluated serial dilutions of the WHO international standard for HDV, PEI 7657/12. All HDV-RNA positive samples were genotyped using a next-generation sequencing strategy.
UNASSIGNED: Qualitative results indicated a 100% concordance between tests. Quantitative results correlated well, r2 = 0.703 (Vircell-vs-Eurobio), r2 = 0.833 (Vircell-vs-RoboGene), r2 = 0.835 (Robogene-vs-Eurobio). Bias index was 2.083 (Vircell-vs-Eurobio), -1.283 (Vircell-vs-RoboGene), and -3.36 (Robogene-vs-Eurobio). Using the WHO IS, Vircell overestimated the viral load by 0.98 log IU/mL, Eurobio by 1.46 log IU/mL, and RoboGene underestimated it by 0.98 log IU/mL. Fifty-nine samples were successfully genotyped (Genotype 1, n=52; Genotype 5, n=7; Genotype 6, n=1), with similar results for correlation and bias.
UNASSIGNED: This study underscores the necessity of using reliable HDV-RNA detection and quantification assays, as evidenced by the high concordance rates in qualitative detection and the observed variability in quantitative results. These findings highlight the importance of consistent assay use in clinical practice to ensure accurate diagnosis and effective treatment monitoring of HDV infection.
UNASSIGNED: Hepatitis Delta RT-PCR system kit, EurobioPlex HDV assay, and RoboGene HDV RNA Quantification kit 2.0 were used for testing 151 HBsAg-positive samples, 90 HDV-RNA negative and 61 HDV-RNA positive. We also evaluated serial dilutions of the WHO international standard for HDV, PEI 7657/12. All HDV-RNA positive samples were genotyped using a next-generation sequencing strategy.
UNASSIGNED: Qualitative results indicated a 100% concordance between tests. Quantitative results correlated well, r2 = 0.703 (Vircell-vs-Eurobio), r2 = 0.833 (Vircell-vs-RoboGene), r2 = 0.835 (Robogene-vs-Eurobio). Bias index was 2.083 (Vircell-vs-Eurobio), -1.283 (Vircell-vs-RoboGene), and -3.36 (Robogene-vs-Eurobio). Using the WHO IS, Vircell overestimated the viral load by 0.98 log IU/mL, Eurobio by 1.46 log IU/mL, and RoboGene underestimated it by 0.98 log IU/mL. Fifty-nine samples were successfully genotyped (Genotype 1, n=52; Genotype 5, n=7; Genotype 6, n=1), with similar results for correlation and bias.
UNASSIGNED: This study underscores the necessity of using reliable HDV-RNA detection and quantification assays, as evidenced by the high concordance rates in qualitative detection and the observed variability in quantitative results. These findings highlight the importance of consistent assay use in clinical practice to ensure accurate diagnosis and effective treatment monitoring of HDV infection.
摘要：
■精确的HDV-RNA检测和定量对于诊断和监测对新批准的治疗的反应至关重要。我们评估了三种HDVRNA检测和定量测定的性能。
■丁型肝炎RT-PCR系统试剂盒，EurobioPlexHDV测定，和RoboGeneHDVRNA定量试剂盒2.0用于检测151HBsAg阳性样品，90个HDV-RNA阴性,61个HDV-RNA阳性。我们还评估了WHOHDV国际标准的系列稀释度，PEI7657/12.使用下一代测序策略对所有HDV-RNA阳性样品进行基因分型。
■定性结果表明测试之间100%一致。定量结果相关性很好，r2=0.703（Vircell-vs-Eurobio），r2=0.833（Vircell-vs-RoboGene），r2=0.835(Robogene-vs-Eurobio)。偏差指数为2.083（Vircell-vs-Eurobio），-1.283（Vircell-vs-RoboGene），和-3.36（Robogene-vs-Eurobio）。使用WHOIS，Vircell高估了病毒载量0.98logIU/mL，Eurobio的1.46logIU/mL，RoboGene低估了0.98logIU/mL。59个样本成功地进行了基因分型(基因型1,n=52;基因型5,n=7;基因型6,n=1),相关性和偏差的结果相似。
■这项研究强调了使用可靠的HDV-RNA检测和定量测定的必要性，定性检测的高一致性率和观察到的定量结果的可变性证明了这一点。这些发现强调了在临床实践中使用一致的测定以确保HDV感染的准确诊断和有效治疗监测的重要性。
■丁型肝炎RT-PCR系统试剂盒，EurobioPlexHDV测定，和RoboGeneHDVRNA定量试剂盒2.0用于检测151HBsAg阳性样品，90个HDV-RNA阴性,61个HDV-RNA阳性。我们还评估了WHOHDV国际标准的系列稀释度，PEI7657/12.使用下一代测序策略对所有HDV-RNA阳性样品进行基因分型。
■定性结果表明测试之间100%一致。定量结果相关性很好，r2=0.703（Vircell-vs-Eurobio），r2=0.833（Vircell-vs-RoboGene），r2=0.835(Robogene-vs-Eurobio)。偏差指数为2.083（Vircell-vs-Eurobio），-1.283（Vircell-vs-RoboGene），和-3.36（Robogene-vs-Eurobio）。使用WHOIS，Vircell高估了病毒载量0.98logIU/mL，Eurobio的1.46logIU/mL，RoboGene低估了0.98logIU/mL。59个样本成功地进行了基因分型(基因型1,n=52;基因型5,n=7;基因型6,n=1),相关性和偏差的结果相似。
■这项研究强调了使用可靠的HDV-RNA检测和定量测定的必要性，定性检测的高一致性率和观察到的定量结果的可变性证明了这一点。这些发现强调了在临床实践中使用一致的测定以确保HDV感染的准确诊断和有效治疗监测的重要性。
