Analysis of sera indeterminate by Ortho-HCV RIBA-2 by using three confirmatory assays for anti-hepatitis C virus antibody

J Clin Microbiol. 1994 Sep;32(9):2071-5. doi: 10.1128/jcm.32.9.2071-2075.1994.

Abstract

The diagnostic performances of three commercially available recombinant immunoblot assays (RIBAs) for anti-hepatitis C virus antibody were evaluated on 50 ORTHO-HCV RIBA-2 (RIBA-2)-indeterminate serum samples. Concordant interpretations were obtained with the three tests in 60% of the samples, with 56% positive, 2% indeterminate, and 2% negative results. Considering test performance in regard to the number of remaining indeterminate results, analyzing sera by RIBA-3, INNO-LIA HCV Ab III, and DECISCAN HCV reduced the number of samples reacting indeterminately to 40, 6, and 8%, respectively. The three serum samples classified as indeterminate in the INNO-LIA HCV Ab III as well as three of four serum samples interpreted as indeterminate in the DECISCAN HCV and 16 of 20 samples classified as indeterminate in the RIBA-3 were hepatitis C virus RNA positive by PCR. This study clearly shows the good performance of the three tests as confirmatory assays compared with that of the RIBA-2. However, according to the manufacturers' criteria of positivity, the INNO-LIA HCV Ab III and DECISCAN HCV appeared to be more suitable than the RIBA-3 for interpreting serum samples found indeterminate in the RIBA-2.

Publication types

  • Comparative Study

MeSH terms

  • Antigens, Viral / immunology
  • Evaluation Studies as Topic
  • Hepacivirus / immunology*
  • Hepacivirus / isolation & purification
  • Hepatitis Antibodies / blood*
  • Hepatitis C / blood
  • Hepatitis C / diagnosis*
  • Hepatitis C Antibodies
  • Humans
  • Immunoblotting*
  • Polymerase Chain Reaction
  • Predictive Value of Tests
  • RNA, Viral / blood
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity
  • Viremia / microbiology

Substances

  • Antigens, Viral
  • Hepatitis Antibodies
  • Hepatitis C Antibodies
  • RNA, Viral
  • Reagent Kits, Diagnostic