SUMMARYBackground: The epidemiology and clinical significance of occult hepatitis B virus infection (serum hepatitis B surface antigen-negative patients with detectable hepatitis B virus viraemia in serum) remains controversial with only limited information about its prevalence in patients on long-term dialysis. Aim: To address the epidemiology of occult HBV infection in a large cohort of dialysis patients. Methods: We screened a large cohort (n ¼ 585) of Italian chronic dialysis patients; from this population, a group of hepatitis B virus surface antigen seronegative patients (n ¼ 213) was tested by Amplicor hepatitis B virus Monitor Test to detect hepatitis B virus viraemia (hepatitis B virus-DNA) in serum. Results: Occult hepatitis B virus infection was absent (zero of 213 ¼ 0%). Persistent hepatitis B virus surface antigen carriage was less frequent than anti-hepatitis B virus core antibody (anti-hepatitis B core antigen) seropositive status in this study group [1.88% (11 of 585) vs. 36% (216 of 585), P ¼ 0.0001]. No dialysis
Dialysis patients remain a high-risk group for hepatitis C virus (HCV) infection. The current diagnosis of HCV infection among dialysis patients includes serological assays and nucleic acid amplification technology (NAT) for assessing serum anti-HCV antibody and HCV viremia, respectively. However, current NAT techniques are expensive and labor-intensive and often lack standardization. An assay prototype designed to detect and quantify total HCV core antigen (total HCV core Ag) protein in serum and plasma in the presence or absence of anti-HCV antibodies has been recently developed. A comparison between a total anti-HCV core Ag enzyme-linked immunosorbent assay (ELISA) and a quantitative HCV RNA assay based on reverse transcription-PCR (RT-PCR) (Amplicor HCV Monitor test) was performed using a large (n ؍ 305) cohort of ELISA HCV 3.0 HCV-negative and -positive patients on maintenance dialysis. The concentrations of HCV core Ag and HCV RNA levels (measured by RT-PCR) were significantly correlated (r ؍ 0.471, P ؍ 0.0001) over a wide range of HCV RNA levels and were maintained among different HCV genotypes (HCV genotype 1, r ؍ 0.862, P ؍ 0.0001; HCV genotype 2, r ؍ 0.691, P ؍ 0.0001). We estimated that 1 pg of total HCV core Ag per ml is equivalent to approximately 19.952 IU of HCV RNA per ml, even if the wide range in the ratio of core Ag to HCV RNA (95% confidence intervals, 2.8 ؋ 10 3 to 1.6 ؋ 10 5 IU/ml) precluded definitive conclusions. In summary, total HCV core Ag proved to be useful for performing HCV RNA measurement among dialysis patients in routine laboratories without the need for special equipment or training. The present study supports the use of the total anti-HCV core Ag ELISA for assessing viral load among dialysis patients with HCV infection.Dialysis patients remain a high-risk group for hepatitis C virus (HCV) infection (11). The Centers for Disease Control and Prevention, Atlanta, Ga., have recently included semiannual anti-HCV testing for anti-HCV-negative patients in their infection control practices for hemodialysis units (6, 7).Routine diagnosis of HCV is based on detection of anti-HCV antibody. However, due to the absence of an efficient in vitro culture system for HCV or assays capable of detecting viral antigens, direct detection of HCV has depended on nucleic acid amplification technology (NAT) techniques. Indeed, serological assays for detecting anti-HCV antibody cannot distinguish between patients with active infection and those who have cleared the virus (29). NAT tests are based on nucleic acid amplification (PCR and transcription-mediated amplification) (16, 37) or signal amplification (branched-chain DNA assay) and are currently used to detect viremia (2, 36). Recently both assay systems have become semiautomated. Several problems still persist with these methods; PCR requires considerable skill and has limited reproducibility, while the branched-chain DNA assay requires a long incubation period. Both assays are also expensive. An assay prototype designed to detect and ...
Our data show that detectable HCV RNA in serum is a strong independent predictor of raised aminotransferase values in chronic dialysis patients; the relationship between serum aminotransferase values and anti-HCV antibody was exclusively related to the association between raised aminotransferase values and HCV viraemia; HCV RNA positive patients show higher hepatic enzyme levels than dialysis patients with no detectable HCV RNA; no association between HCV genotype and serum aminotransferase activity was apparent.
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