Detection &Viral Load Monitoring of Adenovirus

Period of Performance: 08/01/2003 - 01/31/2004

$100K

Phase 2 SBIR

Recipient Firm

Viracor Holdings
Lee'S Summit, MO 64086
Principal Investigator

Abstract

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.