VIRUS INACTIVATION OF HUMAN BLOOD BEFORE CLINICAL ASSAYS

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DESCRIPTION: The objective of this proposal is to develop a practical method for virus inactivation in blood samples for clinical laboratory testing. The method represents a significant commercial opportunity and is applicable to specimens contaminated with pathogenic viruses like HIV or hepatitis C (HCV). Viral inactivation is achieved by a novel class of agents, InactineSTM, highly selective for the nucleic acid, that do not modify hematological and clinical chemistry analyses. Preliminary studies have shown that certain InactineSTM inactivate Venezuelan equine encephalitis, Ebola, and other viruses at up to 2 logs/hour. Serum enzymes and hematological tests were preserved under conditions that efficiently inactivated these viruses. In this proposal, a series of InactineSTM will be synthesized for use in vacuum blood tubes. The most active compound will be selected using a standardized assay, and optimal conditions for inactivation determined in human serum and whole blood. Inactivation kinetics will be defined for HIV and a model virus for HCV. Finally, the stability of hematological and clinical chemistry analyses in blood samples will be measured under optimal conditions for viral inactivation. PROPOSED COMMERCIAL APPLICATION: The commercial application is for the inactivation of viruses in blood collected in evacuated blood collection tubes for laboratory analysis. The goal is to provide an increased level of safety for the employees who will be handling and processing the blood.