title: Sensitivity of a modified version of the ARCHITECT Anti-HCV test in detecting samples with immunoblot-confirmed, low-level antibody to hepatitis C virus.
abstract: OBJECTIVE
  Compliance with current regulations regarding the prevention of hepatitis C virus (HCV) transmission in the blood transfusion setting requires the use of sensitive assays for HCV antibody (anti-HCV) detection, which should, ideally, identify any donor having had prior contact with the virus. Therefore, low-level anti-HCV positive blood units should be detected by the screening assays, even those reflecting a past and resolved infection. To assess the sensitivity of two versions of an automated chemiluminescent microparticle immunoassay (CMIA) for anti-HCV screening (ARCHITECT Anti-HCV), 113 single serum samples containing low levels of anti-HCV, assessed by two immunoblot tests, were selected from 3686 samples received for confirmation of HCV infection by a reference laboratory over a 2-year period.
  
  
  METHODS
  The panel included 17 samples with HCV RNA detected by the polymerase chain reaction (PCR) and 96 PCR negative samples with either positive or indeterminate (anti-Core and anti-NS3 alone) results by immunoblot.
  
  
  RESULTS
  All but 13 specimens (100/113, 88.5%) were detected by the current version of the ARCHITECT Anti-HCV assay and 10 additional samples (110/113, 97.3%) tested positive in a modified version of the test.
  
  
  CONCLUSIONS
  The results showed that the modification introduced in the ARCHITECT Anti-HCV assay achieves a significant sensitivity improvement including samples with low-level anti-HCV which are either PCR positive or negative.
authors.affiliation: Service of Diagnostic Microbiology, National Centre of Microbiology, Instituto de Salud Carlos III, Majadahonda, 28220 Madrid, Spain. jmecheva@isciii.es
authors.forename: José M
authors.initials: JM
authors.lastname: Echevarría
authors.forename: Ana
authors.initials: A
authors.lastname: Avellón
authors.forename: Gesa
authors.initials: G
authors.lastname: Jonas
authors.forename: Michael
authors.initials: M
authors.lastname: Hausmann
authors.forename: Angela
authors.initials: A
authors.lastname: Vockel
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Kapprell
mesh_terms: D001331:Automation; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay; D015151:Immunoblotting; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D018937:Hepatitis C Antibodies; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic