Evaluation of a total core antigen assay for the diagnosis of hepatitis C virus infection in hemodialysis patients

Abstract

Hemodialysis patients are recognized as a group at high risk of infection with hepatitis C virus (HCV). Therefore, such a population should be screened routinely for the presence of HCV viremia. Since nucleic acid techniques remain expensive and largely unavailable in many laboratories in the developing world, the present study assesses the clinical usefulness of the HCV core antigen enzyme immunoassay for the diagnosis of HCV infection in dialysis patients. One hundred seventy-five dialysis patients were screened for the presence of anti-HCV antibodies and HCV RNA in the serum. One hundred twenty-eight serum samples were collected from the 76 patients who were anti-HCV antibody- and/or HCV RNA-positive. These were evaluated for total HCV core antigen. Of these samples, 55 had sufficient volume to be further tested to quantify HCV RNA by reverse transcription polymerase chain reaction (RT-PCR). Genotyping of the HCV strains showed that the majority belonged to genotype 1b (77%). The HCV core antigen assay showed a sensitivity and specificity of 84% and 89%, respectively. The use of core antigen assay has enabled the early detection of three patients who developed an acute hepatitis C infection during the period of study. A correlation study was undertaken between the quantitative values of viral load, expressed as pg/ml of HCV core antigen in serum, and viral RNA in UI/ml. A significant correlation was observed (Pearson's correlation coefficient: 0.552; P<0.001). In conclusion, detection of HCV core antigen in serum is an inexpensive, reliable, and highly specific assay that can be useful in most laboratory settings to diagnose HCV infection, and especially in laboratories where nucleic acid technologies are not yet available.

Analytical Performance Characteristics and Clinical Utility of a Novel Assay for Total Hepatitis C Virus Core Antigen Quantification

“…The detection and quantification of HCV core antigen in the serum or plasma of infected patients by using different assay formats were previously shown to narrow the preseroconversion (window) phase of acute HCV infections (26,30) and to be a useful marker of viral replication (4,5,11,13,23,34,42,47).…”

Hepatitis C in Hemodialysis Patients: Current Global Magnitude, Natural History, Diagnostic Difficulties, and Preventive Measures

“…1, 2, 3 summarize the details of published reports since 1999 on HCV prevalence in Asian (table 1), US and European (table 2), and African and non-US American (table 3) HD patients. Reports of high (>40%) HCV seroprevalence in HD patients were from Brazil [73], Peru [76], Bosnia and Herzegovina [42], Senegal [63], Syria [38], Tunisia [66], Pakistan [33], Saudi Arabia [21], Iran [27], and Moldavia [51]. However, reports from these countries were not congruent.…”

“…The efficacy of HCVcAg ELISA ranged from 81.9 [23] to 95.9% [103]. However, one should note that HCVcAg has low sensitivity for diagnosis of HCV infection in patients with low HCV viral loads (below 4.1 log 10 IU/ml) [66, 103]. In one study, there were no HCV RNA-positive patients who tested negative for both HCVcAg and anti-HCV antibody [66].…”

“…However, one should note that HCVcAg has low sensitivity for diagnosis of HCV infection in patients with low HCV viral loads (below 4.1 log 10 IU/ml) [66, 103]. In one study, there were no HCV RNA-positive patients who tested negative for both HCVcAg and anti-HCV antibody [66]. Thereupon, it is reasonable to assume that a combination of anti-HCV antibody and HCVcAg ELISA assays would add to the sensitivity of a screening program.…”

Management of hepatitis C virus infection in hemodialysis patients

“…Mello Lde et al [23] , 2007 Lopes et al [24] , 2006 Albuquerque et al [25] , 2005 Carneiro et al [26] , 2001 China Maintain 7.01%-37.34% Ren et al [27] , 2011 Qi et al [28] , 2003 Greece 10%-29% Garinis et al [29] , 1999 Rigopoulou et al [30] , 2005 Sypsa et al [31] , 2005 Sweden 11.0% Almroth et al [32] , 2002 Iran 13.2% Alavian et al [33] , 2003 France 16.3% Salama et al [34] , 2000 Tunisia 19%-41.7% Bouzgarrou et al [35] , 2005 Ayed et al [36] , 2003 Libya 20.5% Daw et al [37] , 2002…”