Detection & Viral Load Monitoring of Adenovirus

I期项目描述（由申请人提供）：腺病毒（AdVs）越来越被认为是一种病毒性病原体，可导致显著的发病率和死亡率，特别是在免疫功能低下的患者中。据报道，免疫功能低下患者的肺炎死亡率高达60%，肝炎死亡率高达50%，总体死亡率高达25%。这些患者严重AdV感染的管理需要早期诊断，与其他疾病区分开来，以及在治疗后监测感染的能力。不幸的是，目前尚不存在快速、准确和定量的AdV诊断技术。ViraCor希望为临床医生提供一种新的诊断工具，它将彻底改变AdV感染的诊断和管理方式，从而降低死亡率。该项目的目的是揭示定量、实时PCR技术是否可以应用于AdV，以产生一种诊断测试，可以提供准确和早期的病毒检测。

DESCRIPTION OF PHASE I PROJECT (provided by applicant): Adenoviruses (AdVs) are increasingly recognized as viral pathogens that can cause significant morbidity and mortality, especially in the immunocompromised patient. Mortality rates in the immunocompromised patient have been reported to be as high as 60 percent for pneumonia, 50 percent for hepatitis and 25 percent overall. Management of serious AdV infections in these patients requires early diagnosis, differentiation from other conditions and the ability to monitor the infection after treatment. Unfortunately, rapid, accurate and quantitative diagnostic techniques for AdV do not exist at this time. ViraCor would like to offer the clinician a new diagnostic tool that will revolutionize the way AdV infections are diagnosed and managed, thereby reducing mortality rates. The aim of the project is to uncover whether quantitative, real-time PCR technology can be applied to AdV to produce a diagnostic test that can provide accurate and early detection of the virus. The applicants' preliminary work indicates that primers against the hexon region of the AdV genome, which is shared by all the AdVs, will be highly sensitive and specific for the molecular detection of the virus. Upon completion of the studies showing that the primers can detect most, if not all the AdV strains, the investigators will proceed to optimization of specimen types, specimen processing and DNA isolation methods. There are potentially significant differences in these areas, which could change the overall impression of total viral load in the patient. Concurrently, the applicants will be establishing performance characteristics of the assay: range, linearity, reproducibility, and coefficient of variation for intra-assay and inter-assay conditions. After meeting these goals the investigators will go to their study collaborators and obtain retrospective specimens from patients with culture proven AdV infections to begin correlation of quantitative laboratory data with clinical presentation. The goal is to show total viral load from optimized specimens correlates with severity and progression of the clinical picture.