AP-HP, hôpital Paul Brousse, Laboratoire de virologie, Villejuif 94800, France.
AP-HP, hôpital Paul Brousse, Laboratoire de virologie, Villejuif 94800, France; Division of Virology, WHO Rubella National Reference Laboratory, Dept of Biology Genetics, Paul Brousse Hospital, Paris Saclay University Hospital, APHP, Villejuif, France.
J Virol Methods. 2024 Sep;329:114982. doi: 10.1016/j.jviromet.2024.114982. Epub 2024 Jul 4.
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.
免疫功能低下患者极易受到常见或机会性病毒感染。定量检测临床标本中的病毒载量对于此类患者人群（尤其是移植受者）的感染和再激活的诊断和管理非常重要。由于关于体外诊断方法的新法规“IVDR”即将在法国生效，诊断实验室必须采用与该新法规兼容的方法和系统。使用参考试剂盒在 146 份临床样本中对 AltoStar 自动化系统 AM16 上的 AltoStar 腺病毒（AdV）、巨细胞病毒（CMV）和人类疱疹病毒-6（HHV-6）DNA PCR 试剂盒 1.5 的技术性能进行了评估。在临床标本中总体符合率分别为 87.5%（28/32）、96.8%（62/64）、100%（22/22）、100%（28/28）和 92.8%（26/28），分别用于 AdV、CMV（WB 样本和其他基质）、HHV-6 A&B。定量结果高度相关，估计在 0.057-0.648 对数数量级的差异内等效。我们发现，在 AltoStar AM16 系统上的 altona 试剂盒适用于免疫功能低下宿主中 AdV、CMV 和 HHV-6 的临床监测。
