Abstract
Quantitative tests for the detection of hepatitis C virus ribonucleic acid (HCV-RNA) levels and HCV core antigen have been mainly used for the management of patients with HCV infection. The aim of this study was to evaluate the correlation between HCV core antigen and HCV RNA levels in patients reactive for anti-HCV antibodies. Three hundred and twenty-five anti-HCV reactive sera samples were included in the study. HCV core antigen and HCV RNA levels were determined using the Architect HCV Ag test and Abbott RealTimeTM HCV RNA test (RT-PCR), respectively. The correlation coefficient between the levels of HCV core antigen and HCV RNA test results was calculated using Spearman’s rank test, and linear regression analysis was applied. One hundred and sixteen of the 325 samples were detected positive by both methods. Three additional samples by RT-PCR, and 4 samples by Architect HCV Ag, the negative samples were found positive by the other method. All of these contradictory results were obtained from the low level HCV RNA or HCV core antigen including samples. A correlation coefficient (r) was determined as 0.899 between the levels of HCV core antigen and HCV RNA (p<0.0001). The sensitivity, specificity, positive predictive value and negative predictive value of the HCV core antigen test were 97.48, 98.06, 96.67 and 98.54%, respectively, using the HCV RNA test as a reference. The Architect HCV core antigen test exhibits a good correlation with the HCV RNA test. It can be used as an alternative method, especially when the HCV RNA test is unavailable. Key words: Anti- hepatitis C virus, Architect hepatitis C virus Ag test, hepatitis C virus RNA.
Highlights
The most frequently used screening method in the diagnosis of hepatitis C virus (HCV) infections is the detection of anti-HCV antibodies in serum or plasma
The purpose of this study was to compare the results of the architect HCV core antigen test, which has newly been introduced in Turkey with the HCV RNA results obtained from the Abbott RealTimeTM HCV RNA test (Abbott Molecular Inc., Des Plaines, IL, USA) and to determine the correlation between the two
When the HCV RNA test was regarded as a reference test, HCV core antigen test sensitivity, specificity, PPV and NPV rates were calculated as described by Akobeng AK (2007), and found as 97.48, 98.06, 96.67 and 98.54%, respectively
Summary
The most frequently used screening method in the diagnosis of hepatitis C virus (HCV) infections is the detection of anti-HCV antibodies in serum or plasma. Anti-HCV antibodies reached detectable levels in the serum after a long window period of HCV infection. Even if the virus is eliminated from the blood its presence may persist for many years, for which reason this method cannot be used for the differentiation of active or past infection or for monitoring antiviral therapy. Tests used for determining anti-HCV antibodies can give false positive results for various reasons (Chevaliez, 2011; Richter 2002; Alter et al, 2003)
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