High Prevalence of Hepatitis C Virus (HCV) RNA in Dialysis Patients: Failure of Commercially Available Antibody Tests to Identify a Significant Number of Patients with HCV Infection

Abstract

Results of serologic tests were correlated with hepatitis C virus (HCV) viremia, determined by a cDNA polymerase chain reaction assay to detect HCV RNA, in 340 Danish dialysis patients; of these, 28 (8.2%) were positive for antibodies to HCV (anti-HCV) with second-generation ELI-SAs. HCV RNA was found in sera from 27 of these 28 anti-HCV-positive patients. However, 8 dialysis patients had detectable levels of HCV RNA but were anti-HCV-negative with second-generation ELISAs. Among the 35 HCV-infected dialysis patients 16 were positive, 7 indeterminate, and 12 negative with the second-generation RIBA. More than 60% of patients with evidence of ongoing liver disease had HCV infection. Thus, current commercially available antibody tests did not accurately reflect the HCV status in dialysis patients. A relatively high prevalence (> 10%) of HCV RNA, closely associated with liver disease, was found among dialysis patients in a low-prevalence area of the world.

Novel Assay Using Total Hepatitis C Virus (HCV) Core Antigen quantification for Diagnosis of HCV Infection in Dialysis Patients

“…HCV viremia can be demonstrated in a small but significant minority of dialysis patients who are negative by anti-HCV serological testing (4,15,18,19,32). Immunocompromise due to chronic uremia may limit the ability of dialysis patients to mount an antibody response to viral antigens.…”

Role of hepatitis C virus in chronic liver disease occurring after orthotopic liver transplantation.

“…These false positive results in antihepatitis C virus assays have been previously reported23 24 and may lead to overestimation of the prevalence of hepatitis C virus infection. RIBA negativity does exclude hepatitis C virus inlfection.25 26 Conclusion Systematic screening of patients and donors for hepatitis C virus is mandatory, before and after transplantation. Negative antihepatitis C virus assays do not exclude hepatitis C virus infection, and positive tests must be confirmed by RIBA test and detection of serum hepatitis C virus RNA.…”

Relevance of Reactivity in Commercially Available Hepatitis C Virus Antibody Assays

“…These patients are especially hard to advise. Immunological disorders may contribute to a low or absent antibody response, as has been described for patients on chronic hemodialysis (2,13). However, we have no evidence that underlying immunosuppression was the cause of a weak immune response in those 35 patients with indeterminate test results.…”