title: Cost-effective analysis of different algorithms for the diagnosis of hepatitis C virus infection.
abstract: We compared the cost-benefit of two algorithms, recently proposed by the Centers for Disease Control and Prevention, USA, with the conventional one, the most appropriate for the diagnosis of hepatitis C virus (HCV) infection in the Brazilian population. Serum samples were obtained from 517 ELISA-positive or -inconclusive blood donors who had returned to Fundação Pró-Sangue/Hemocentro de São Paulo to confirm previous results. Algorithm A was based on signal-to-cut-off (s/co) ratio of ELISA anti-HCV samples that show s/co ratio > or =95% concordance with immunoblot (IB) positivity. For algorithm B, reflex nucleic acid amplification testing by PCR was required for ELISA-positive or -inconclusive samples and IB for PCR-negative samples. For algorithm C, all positive or inconclusive ELISA samples were submitted to IB. We observed a similar rate of positive results with the three algorithms: 287, 287, and 285 for A, B, and C, respectively, and 283 were concordant with one another. Indeterminate results from algorithms A and C were elucidated by PCR (expanded algorithm) which detected two more positive samples. The estimated cost of algorithms A and B was US$21,299.39 and US$32,397.40, respectively, which were 43.5 and 14.0% more economic than C (US$37,673.79). The cost can vary according to the technique used. We conclude that both algorithms A and B are suitable for diagnosing HCV infection in the Brazilian population. Furthermore, algorithm A is the more practical and economical one since it requires supplemental tests for only 54% of the samples. Algorithm B provides early information about the presence of viremia.
authors.affiliation: Departamento de Análises Clínicas e Toxicológicas, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brasil. amegydio@uol.com.br
authors.forename: A M E C
authors.initials: AM
authors.lastname: Barreto
authors.forename: K
authors.initials: K
authors.lastname: Takei
authors.forename: Sabino
authors.initials: S
authors.lastname: E C
authors.forename: M A O
authors.initials: MA
authors.lastname: Bellesa
authors.forename: N A
authors.initials: NA
authors.lastname: Salles
authors.forename: C C
authors.initials: CC
authors.lastname: Barreto
authors.forename: A S
authors.initials: AS
authors.lastname: Nishiya
authors.forename: D F
authors.initials: DF
authors.lastname: Chamone
mesh_terms: D000465:Algorithms; D001782:Blood Donors; D001938:Brazil; D003362:Cost-Benefit Analysis; D004797:Enzyme-Linked Immunosorbent Assay / Q000191:economics; D016174:Hepacivirus / Q000235:genetics* / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis* / Q000191:economics; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D015151:Immunoblotting / Q000191:economics; D016133:Polymerase Chain Reaction / Q000191:economics; D012367:RNA, Viral / Q000032:analysis*; D011933:Reagent Kits, Diagnostic / Q000191:economics; D012680:Sensitivity and Specificity
chemical_list: D018937:Hepatitis C Antibodies; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic