FAILURE TO DETECT HEPATITIS-C VIRUS (HCV) GENOME BY POLYMERASE CHAIN-REACTION IN HUMAN ANTI-HCV-POSITIVE INTRAVENOUS IMMUNOGLOBULINS

The prevalence of HCV antibodies was determined by a second-generation ELISA and a four-antigen recombinant immunoblot assay in nine intrave nous immunoglobulin (IVIG) preparations commercially available in Ital y. In addition, the clinical safety of six of them was ascertained by polymerase chain reaction (PCR) of HCV RNA and a prospective study in 14 patients with immunodeficiency disorders. Results indicated that al l IVIG preparations were anti-HCV-positive. However, there were substa ntial variations in their anti-HCV antibody titres. The preparations r etained IgG subclass reactivities to HCV-associated structural (C22-3) and non-structural (C33c, C100-3) proteins. Our sensitive and specifi c PCR assay was unable to detect HCV RNA in the six preparations teste d. Clinical surveillance of IVIG-treated patients prospectively evalua ted over a mean period of 8.3 months failed to detect clinical and/or biochemical evidence of hepatitis.