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. 2014 Apr:199:119-23.
doi: 10.1016/j.jviromet.2014.01.002. Epub 2014 Jan 30.

Screening for hepatitis C virus infection in a high prevalence country by an antigen/antibody combination assay versus a rapid test

Claude Tayou Tagny  1 , Dora Mbanya  1 , Edward L Murphy  2 , Jean-Jacques Lefrère  3 , Syria Laperche  4
Affiliations

Screening for hepatitis C virus infection in a high prevalence country by an antigen/antibody combination assay versus a rapid test

Claude Tayou Tagny et al. J Virol Methods. 2014 Apr.

Abstract

In low-income-countries, screening for hepatitis C virus (HCV) infection is often based on rapid tests (RT). Their lower sensitivity compared to enzyme immunoassay (EIA) suggests that newer HCV Antigen/Antibody (Ag/Ab) combination assays might have a role in such countries. To test this idea, 1998 blood donors were tested at the University Teaching Hospital blood bank in Yaoundé, Cameroon simultaneously with a RT (HCV rapid test, Human Diagnostics, Berlin, Germany) according to standard practice (S1) and with an Ag/Ab assay (Monolisa HCV Ag/Ab Ultra, Biorad, France) (S2). All discordant, borderline and reactive samples were submitted to confirmatory testing by immunoblot and/or HCV-RNA. Of the 86 (4.3%) samples positive with one or both strategies, 29 were confirmed negative, 37 positive and 20 were false positive or resolved infection. There was a significant difference in test sensitivity (p=0.01) between S1 (70.3%) and S2 (91.9%) but not in test specificity (99.4% and 98.6%, respectively). The benefit of the Ag/Ab assay in the detection of recent HCV seronegative infections could not be evaluated since no Antigen-only donations were identified. However, better Ag/Ab test sensitivity compared to RT supports the implementation of these newer immunoassays for HCV screening in the African blood bank setting.

Keywords: Africa; Ag/Ab combination assay; Blood donors; HCV; Rapid tests.

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Conflict of interest statement

The authors who have taken part in this study declared that they do not have conflict of interest with respect of this manuscript.

Figures

Fig. 1
Fig. 1
Screening algorithm and classification of the 1998 tested blood donations according to results obtained with confirmatory investigations. The number of samples included in each category were divided according to groups (g1–g4) to which they belonged after the screening. S1: Hexagon HCV, Human Diagnostics, Berlin, Germany; S2: Monolisa HCV Ag–Ab Ultra, BioRad, Marnes La Coquette, France; RIBA: RIBA 3, Ortho Clinical Diagnostics, Issy les Moulineaux, France; HCV-RNA: Cobas TaqMan HCV, Roche Diagnostic, Meylan, France
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