Objective:

The aim of this study is to evaluate an immunoenzymatic antigenic detection for early diagnosis of hepatitis C virus (HCV) infection in dialysis patients.

Patients and Methods:

We used the enzyme-linked immunosorbent assay (Ortho HCV 3.0 ELISA test System; Ortho-Clinical Diagnostics) for the detection of antibody to HCV in 144 patients with chronic renal failure treated in the haemodialysis department of our hospital. Total HCV Core Antigen was determined by an immunoassay (Track-C, Ortho Total HCV Antigen Assay, Ortho-Clinical Diagnostics) and compared with measures obtained by Cobas Amplicor HCV test version 2.0 (Cobas Amplicor and Cobas Amplicor Monitor HCV, Roche Molecular Systems). All assays were performed according to the manufacturer's instructions. The cut-off value for HCV Antigen was 1.5 pg/mL. The cut-off value for the Cobas Amplicor HCV test was 50 UI/mL and for the Amplicor HCV Monitor test was 600 UI/mL.

Results:

The patients with anti HCV antibody-positive (25) showed a global correlation between the HCV Core Antigen and the Amplicor HCV test of 92% (Table 1) and the patients with anti HCV antibody-negative (119) showed a global correlation of 95.8% (Table 2).

Conclusions:

There was a good correlation between the HCV-PCR and the HCV Core Antigen. This assay is a new useful test for early detection of HCV infection in this study group.

Table 1.