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Title: Evaluation of the use of a combined hcv antigen/antibody assay in routine laboratory practice
Authors: Vermeersch, Pieter ×
Van Ranst, Marc
Lagrou, Katrien #
Issue Date: Jul-2010
Publisher: Acta clinica belgica
Series Title: Acta Clinica Belgica vol:65 issue:4 pages:245-247
Abstract: BACKGROUND: Combined hepatitis C virus (HCV) antigen/antibody (Ag/Ab) assays offer the advantage of a shorter window phase compared to traditional anti-HCV antibody assays. These assays have been extensively evaluated for the screening of healthy blood donors, but not in routine laboratory practice.

METHODS: We evaluated the performance of the combined HCV Ag/Ab assay Monolisa Ultra and compared it to Monolisa anti-HCV Plus (which only detects anti-HCV antibodies) in 61 HCV RNA-positive patients (genotypes 1 to 5) and in 276 consecutive AxSYM HCV-reactive patients. Discordant sera were tested with immunoblot and PCR.

RESULTS: All 61 PCR-positive sera were positive with AxSYM, Monolisa Ultra, and Monolisa Plus. Of the 276 consecutive AxSYM-reactive patients, 177 were confirmed as HCV-positive, 78 were HCV-negative and 21 were HCV-indeterminate. There were 4 false-positive results with Monolisa Ultra compared to 1 false-positive result with Monolisa PLus. The signal/cut-off ratio in immunoblot-negative sera was significantly higher with HCV Ultra compared to HCV Plus (p < 0.01). Sensitivity and specificity in AxSYM-reactive sera were 99.4% and 94.9% for Monolisa Ultra and 99.4% and 98.7% for Monolisa Plus.

CONCLUSION: When used as a secondary test, the sensitivity of the combined HCV Ag/Ab assay Monolisa Ultra was excellent, but specificity was reduced in AxSYM-reactive sera compared to Monolisa Plus.
ISSN: 1784-3286
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Clinical Bacteriology and Mycology
Laboratory of Clinical and Epidemiological Virology (Rega Institute)
Cardiology
× corresponding author
# (joint) last author

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