REFINEMENT OF NEW ASSAYS FOR DIRECT DETECTION OF NUCLEIC

Gen-Probe, Inc., San Diego CA

Investigators

Linked publications & trials

Abstract

The objective of the study are: 1) to refine for use in blood bank laboratories, organ donor centers, and hospital laboratories, an amplification and detection system which will simultaneously identify the presence of human immunodeficiency virus (HIV-1) and hepatitis C virus (HCV) nucleic acids in donors of organs for transplantation and close the window period between infectivity and detection to the shorted possible time; and 2) to file for investigational new drug exemption (INDs) with Food and Drug Administration and submit and obtain approval for product license applications (PLAs).