Since the identification and molecular characterization of the non-A, non-B
hepatitis virus (HCV) in 1989, a variety of diagnostic tests based on the
detection of hepatitis virus antibodies or HCV RNA in the serum have been d
eveloped and refined. The enzyme-linked immunosorbent assays (ELISAs) and t
he recombinant immunoblot assays (RIBAs) exhibit improved sensitivity and s
pecificity for HCV antibodies compared with their predecessors, and the ELI
SA-3 is at the forefront of HCV screening. Furthermore, the advent of molec
ular assays that employ quantitative reverse-transcriptase polymerase chain
reaction to detect HCV RNA has allowed clinicians to track the natural his
tory of HCV and to monitor the progress of therapy. A role for further refi
nement of an HCV diagnosis using tests to determine genotype, subtype, and
quasispecies is explored. In addition, the role of liver biopsy and noninva
sive markers of histologic status are placed into the context of patient pr
ognosis. This article reviews the state-of-the-art tests and assays develop
ed for the diagnosis and management of HCV infection.