METHODS: Frozen sera from untreated and BLV-treated CHD patients were tested in a single-centre study for HDV RNA levels (Robogene 2.0, Roboscreen GmbH, Leipzig, Germany; LOD 6 IU/mL) with two extraction methods: manual (INSTANT Virus RNA/DNA kit; Roboscreen GmbH, Leipzig, Germany) versus automated (EZ1 DSP Virus Kit; Qiagen, Hilden, Germany). BLV-treated patients were sampled at baseline and during therapy.
RESULTS: Two hundred sixty-four sera collected from 157 CHD (139 untreated, 18 BLV-treated) patients were analysed: age 51 (28-78), 59% males, 90% of European origin, 60% cirrhotics, ALT 85 (17-889) U/L, HBsAg 3.8 (1.7-4.6) Log IU/mL, 81% HBV DNA undetectable, 98% HDV genotype 1. Median HDV RNA was 4.53 (.70-8.10) versus 3.77 (.70-6.93) Log IU/mL by manual versus automated extraction (p < .0001). Manual extraction reported similar HDV RNA levels in 31 (20%) patients, higher in 119 (76%) [+.5 and +1 log10 in 60; > +1 log10 in 59] and lower in 7 (4%). Among 18 BLV-treated patients, rates of HDV RNA < LOD significantly differed between the two assays at Weeks 16 and 24 (0% vs. 22%, p = .02; 11% vs. 44%, p = .03), but not at later timepoints. By contrast, virological response rates were similar.
CONCLUSIONS: Quantification of HDV RNA by Robogene 2.0 is influenced by the extraction method, the manual extraction being 1 Log more sensitive.
方法:在单中心研究中测试了未经治疗和BLV治疗的CHD患者的冷冻血清的HDVRNA水平(Robogene2.0,莱比锡,德国;LOD6IU/mL),具有两种提取方法:手动(INSTANT病毒RNA/DNA试剂盒;RoboscreenGmbH,莱比锡,德国)与自动(EZ1DSP病毒试剂盒;Qiagen,希尔登,德国)。BLV治疗的患者在基线和治疗期间取样。
结果:从157例冠心病(139例未经处理,对18例BLV治疗的)患者进行了分析:年龄51岁(28-78岁),59%的男性,90%的欧洲血统,60%肝硬化,ALT85(17-889)U/L,HBsAg3.8(1.7-4.6)LogIU/mL,81%HBVDNA检测不到,98%HDV基因型1。手动与自动提取的HDVRNA中位数为4.53(.70-8.10)对3.77(.70-6.93)LogIU/mL(p<.0001)。手工提取在31(20%)患者中报告了相似的HDVRNA水平,119人中较高(76%)[60人中+5和+1log10;59人中>+1log10],7人中较低(4%)。在18名接受BLV治疗的患者中,在第16周和第24周,两种检测方法的HDVRNA