African Journal of
Microbiology Research

  • Abbreviation: Afr. J. Microbiol. Res.
  • Language: English
  • ISSN: 1996-0808
  • DOI: 10.5897/AJMR
  • Start Year: 2007
  • Published Articles: 5232

Full Length Research Paper

Ortho VITROS enhanced chemiluminescence assay for detection of hepatitis C virus (HCV) antibodies: Determination of a “borderline” range

Arnolfo Petruzziello1*, Nicola Coppola2, Maurizio Fraulo1 , Giovanna Loquercio1, Rosa Azzaro1, Anna Maria Diodato1, Vincenzo Iervolino1, Gaetano Di Costanzo1, Catia Addolorata Di Macchia1, Tommaso Di Meo1, Rosario Ferro3, Pasquale Giuliano3, Giuseppe Pasquale2 and Carmela Cacciapuoti1
1Laboratory of Virology and Molecular Biology “V. Tridente”, Transfusion Service, Department of Haematology, Istituto Nazionale Tumori - Fondazione G. Pascale, Naples, Italy. 2Department of Public Medicine, Section of Infectious Diseases, SUN - Second University of Naples, Naples, Italy. 3ASL Na2 Nord Public Health Company, Sanitary District 43, Casoria, Italy.
Email: [email protected]

  •  Accepted: 26 April 2013
  •  Published: 14 May 2013

Abstract

The diagnostic efficacy of Ortho VITROS chemiluminescence assay (CIA) in detecting antibodies to the hepatitis C virus (HCV) and the clinical significance of specimens with low sample-to-cut off (S/Co) ratio was analysed, comparing the positive rate for CIA in 5,550 consecutive outpatients with enzyme-immunoassay (EIA). In parallel testing, 43 samples (0.8%) were low positive by CIA (S/Co ratio from 1.0 to 8.0) but negative by EIA. No samples CIA negative/EIA positive were found. Among EIA negative results we found 22 RIBA positive or indeterminate, yielding CIA sensitivities of 100% and EIA sensitivity of 97.8%. None of the 33 samples with CIA S/Co ratios of ≤ 2.0 and only 3 (10.7%) with S/Co ratios of between 2.1 and 8.0 were found to be RIBA positive. Instead, the majority of samples with S/Co ratios ≤ 8.0 (55.7%) were recombinant immunoblotting assay (RIBA) negative.  HCV RNA and/ or clinical evidence of HCV infection was not found in any of the 12 indeterminate cases examined with S/Co ratios ≤ 2. We suggest to report them as “Borderline”, with the recommendation to follow up in the future.

 

Key words: HCV infection, RIBA, HCV-RNA, CIA, EIA.