Detection of antibodies to hepatitis C virus: false-negative results in an automated chemiluminescent microparticle immunoassay (ARCHITECT Anti-HCV) compared to a microparticle enzyme immunoassay (AxSYM HCV Version 3.0).

Background: Following an accidental observation of reduced sensitivity for detection of antibodies to hepatitis C virus (HCV) with a novel commercially available automated chemiluminescent microparticle immunoassay (CMIA, ARCHITECT Anti-HCV) compared to a well-established microparticle enzyme immunoassay (MEIA, AxSYM HCV Version 3.0), we wanted to explore whether this could be explained by a variation in marginal sensitivity, to be expected between highly sensitive assays of different formats, or represented a reduced sensitivity of the CMIA to certain antibody profiles.

Objectives: To evaluate the ability of the CMIA to detect low concentrations of anti-HCV antibodies as defined by various patterns in the recombinant immunoblot assay (RIBA) and already detected in the MEIA system.