Analytical evaluation of HCV core antigen and interest for HCV screening in haemodialysis patients

Background: It is important to diagnose a hepatitis C virus infection in the acute phase in order to reduce the incidence of this infection in high-risk populations like haemodialysis patients. But detection systems for serum HCV antibodies are insensitive in the acute phase because of the long serological window. Previous studies showed that the HCV core antigen (HCV Ag) may be an alternative to HCV RNA in this context.

Objectives: To evaluate the performances of the new Abbott ARCHITECT((R)) HCV Ag test and its usefulness in screening for HCV infections in haemodialysis patients.

Study design: The serum HCV Ag titre was compared to the HCV RNA viral load in 98 samples from HCV-infected patients to determine the correlation between the two markers and the influence of genotype. We screened 2752 patients from 37 French haemodialysis units who tested negative for HCV antibodies using the HCV Ag and RNA assays.

Results: The HCV Ag titre was correlated with the HCV RNA (Spearman test coefficient 0.9041, p<0.0001) and all genotypes and subtypes were detected. The HCV Ag and HCV RNA results agreed well for haemodialysis patients. Diagnostic specificity of HCV Ag was high (99.2%) considering HCV RNA as the reference. The two seronegative patients (of 2752) who were HCV RNA positive were also HCV Ag positive.

Conclusions: The ARCHITECT HCV Ag test is a reliable, highly specific assay for screening acute HCV infections in haemodialysis units. It is a robust alternative to HCV RNA testing.