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 ≥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.

The significance of repeat testing in Turkish blood donors screened with HBV, HCV and HIV immunoassays and the importance of S/CO ratios in the interpretation of HCV/HIV screening test results and as a determinant for further confirmatory testing

“…In addition, through the use of a lesser number of test kits, blood banks could gain further cost reductions by using a lesser amount of ancillary laboratory material as well as through decreased personnel time. Somewhat similar to our cost-saving findings, Barreto et al have reported that the use of S/CO value as a determinant for further confirmation testing would be practical as well as more economical in anti-HCV testing (Barreto et al, 2008).…”

Analysis of sample‐to‐cutoff ratios on chemiluminescent immunoassays used for blood donor screening highlights the need for serologic confirmatory testing

“…The data presented in this study demonstrated that high s/co ratios on the PRISM HCV ChLIA were predictive of confirmed‐positive results in our donor population, a finding that has previously been observed with other anti‐HCV screening IAs 1‐14 . A similar correlation between high s/co ratios and confirmed‐positive results was also found for the PRISM HBsAg, HIV O Plus, and HTLV‐I/II ChLIAs.…”

“…The data presented in this study demonstrated that high s/co ratios on the PRISM HCV ChLIA were predictive of confirmed-positive results in our donor population, a finding that has previously been observed with other anti-HCV screening IAs. [1][2][3][4][5][6][7][8][9][10][11][12][13][14] A similar correlation between high s/co ratios and confirmed-positive results was also found for the PRISM HBsAg, HIV O Plus, and HTLV-I/II ChLIAs. However, for all four PRISM assays there was a varying degree of overlap between the s/co ratio distributions for BFR and confirmed-positive results so that high s/co ratios were sometimes attributable to BFR results and, conversely, confirmed-positive samples sometimes gave low s/co ratios.…”

“…A number of reports have shown that relatively high sample-to-cutoff (s/co) ratios on screening immunoassays (IAs) for antibodies to hepatitis C virus (anti-HCV) are predictive of confirmed-positive results in both blood donor [1][2][3][4][5][6][7][8] and nondonor populations. [9][10][11][12][13][14][15][16] As well, it has been suggested that an anti-HCV status can be assigned solely on the basis of screening IA s/co ratios.…”

One or two serological assay testing strategy for diagnosis of HBV and HCV infection? The use of predictive modelling

“…Systematic reviews were commissioned for the development of the WHO guidance on viral hepatitis testing services, described in detail in Amini et al [ 6 ] and Tang et al [ 2 ]. Those reviews identified only one study that had compared the diagnostic accuracy of different testing strategies and this was only for detection of anti-HCV [ 7 ]. As the published literature was unable to provide direct evidence to answer the question of a one-assay versus a two-assay testing strategy for HBsAg and for anti-HCV respectively, a model was developed using the principles of Bayesian statistics.…”