title: Evaluation of blood donors with equivocal hepatitis C serological results.
abstract: OBJECTIVE
  To characterise blood donors with equivocal hepatitis C serological results and to develop an algorithm for their diagnosis and follow-up.
  
  
  METHODS
  Prospective case survey.
  
  
  METHODS
  100 consecutive blood donors referred to the St Vincent's Hospital Liver Clinic, Victoria, with equivocal hepatitis C serological results (positive result for second generation Abbott Enzyme Immunoassay 2.0, but at least one negative result on supplemental testing by first generation Abbott neutralisation assay and Abbott Supplemental Assay for antibody to specific viral antigens).
  
  
  METHODS
  Percutaneous risk factors for hepatitis C exposure, peak serum alanine aminotransferase (ALT) levels, results of alternative immunoassay (Monolisa) and polymerase chain reaction (PCR) to detect hepatitis C viraemia.
  
  
  RESULTS
  Thirty subjects had positive results for alternative immunoassay. A risk factor was identified for 32 subjects and was significantly associated (P < 0.01) with positive results for alternative immunoassay (23/32) and PCR (11/32), abnormal ALT levels (7/32), and strong reactivity on initial immunoassay (23/32). Presence of antibodies to both structural and non-structural antigens was also associated with risk factors and positive alternative immunoassay results.
  
  
  CONCLUSIONS
  A definitive diagnosis was possible in 87% of subjects. A diagnosis of hepatitis C infection was based on positive alternative immunoassay results together with positive PCR results or presence of a risk factor. Hepatitis C was excluded for 60% of patients. The diagnosis for the remaining 13% remained indeterminate, indicating the need for a definitive diagnostic test for hepatitis C.
authors.affiliation: Department of Gastroenterology, St Vincent's Hospital, Melbourne, VIC.
authors.forename: S I
authors.initials: SI
authors.lastname: Strasser
authors.forename: B C
authors.initials: BC
authors.lastname: Smith
authors.forename: K J
authors.initials: KJ
authors.lastname: Watson
authors.forename: P J
authors.initials: PJ
authors.lastname: Coghlan
authors.forename: S A
authors.initials: SA
authors.lastname: Locarnini
authors.forename: P V
authors.initials: PV
authors.lastname: Desmond
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000465:Algorithms; D001782:Blood Donors; D005260:Female; D016174:Hepacivirus / Q000276:immunology; D006508:Hepatitis Antibodies / Q000032:analysis; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D009500:Neutralization Tests; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D012307:Risk Factors; D012698:Serologic Tests; D014766:Viremia / Q000175:diagnosis
chemical_list: D006508:Hepatitis Antibodies; D018937:Hepatitis C Antibodies; D000410:Alanine Transaminase