Abstract：
The vulnerability of immunocompromised patients to common or opportunistic viral infections is particularly high. The quantitation of viral load in clinical specimens is important for the diagnosis and management of the infection and reactivation in this patient population, particularly transplant recipients. As the new regulation \"IVDR\" regarding in vitro diagnosis methods is about to come into effect in France, diagnostic laboratories have to implement methods and systems compatible with this new regulation. Technical performance of the AltoStar® Adenovirus (AdV), Cytomegalovirus (CMV) and human Herpesvirus-6 (HHV-6) DNA PCR Kits 1.5 was assessed on the AltoStar Automation system AM16 using reference kits in 146 clinical samples. Overall agreement in clinical specimens was 87.5 % (28/32), 96.8 % (62/64), 100 % (22/22), 100 % (28/28) and 92.8 % (26/28) for AdV, CMV (WB samples and other matrices), HHV-6 A&B respectively. Quantitative results were highly correlated and estimated to be equivalent within a 0.057-0.648 log-amount difference.We found that altona kits on The AltoStar AM16 system are suitable for clinical monitoring of AdV, CMV and HHV-6 in immunocompromised hosts.
摘要：
免疫功能低下的患者对普通或机会性病毒感染的脆弱性特别高。临床标本中病毒载量的定量对于该患者人群的感染和再激活的诊断和管理很重要。特别是移植接受者。随着关于体外诊断方法的新法规“IVDR”即将在法国生效，诊断实验室必须实施与这一新法规兼容的方法和系统。AltoStar®腺病毒（AdV）的技术性能，巨细胞病毒(CMV)和人疱疹病毒-6(HHV-6)DNAPCR试剂盒1.5在AltoStar自动化系统AM16上使用146个临床样品中的参考试剂盒进行评估。临床标本的总体一致性为87.5%(28/32)，96.8%（62/64），100%(22/22),ADV的100%(28/28)和92.8%(26/28)，CMV(WB样本和其他矩阵)，分别为HHV-6A和B。定量结果高度相关，估计在0.057至0.648对数差异内等效。我们发现AltoStarAM16系统上的altona试剂盒适用于AdV的临床监测，免疫受损宿主中的CMV和HHV-6。
