Improving Diagnosis of Hepatitis C Virus Infection Using Hepatitis C Core Antigen Testing in a Resource-Poor Setting

Abstract INTRODUCTION: We compared the hepatitis C virus (HCV) core antigen test with the HCV RNA assay to confirm anti-HCV results to determine whether the HCV core antigen test could be used as an alternative confirmatory test to the HCV RNA test. METHODS: Sera from 156 patients were analyzed for anti-HCV and HCV core antigen using a chemiluminescent microparticle immunoassay (Architect i2000SR) and for HCV RNA using the artus HCV RG RT-PCR Kit (QIAGEN) in a Rotor-Gene Q instrument. RESULTS: The diagnostic sensitivity, specificity, and positive and negative predictive values of the HCV core antigen assay compared to the HCV RNA test were 77.35%, 100%, 100%, and 89.38%, respectively. HCV core antigen levels showed a good correlation with those from HCV RNA quantification (r =0.872). However, 13 samples with a viral load of less than 4000 IU/mL were negative in the HCV core antigen assay. All gray-zone reactive samples were also RNA positive and were positive on repeat testing. CONCLUSIONS: The Architect HCV core antigen assay is highly specific and has an excellent positive predictive value. At the present level of sensitivity (77%), the study is still relevant in a low-income setting in which most of the HCV-positive patients would go undiagnosed, since HCV RNA testing is not available and/or not affordable. HCV core antigen testing can also help determine the true burden of infection in a population, considering the fact that almost 50% of the anti-HCV positive cases are negative for HCV RNA.

Evaluation of HCV-IgG,HCV-cAg and HCV-RNA in the diagnosis of Hepatitis C / 国际检验医学杂志

Objective To evaluate the diagnostic value of hepatitis C virus core antigen(HCV-cAg),hepatitis C virus(HCV-IgG) and hepatitis C virus(HCV-RNA) in the laboratory diagnosis of Hepatitis C.Methods HCV-cAg and HCV-IgG were detected by enzyme-linked immunosorbent assay(ELISA),HCV-RNA was detected by real-time fluorescent quantitative polymerase chain reaction(RT-PCR) in 84 suspected HCV patients and 87 healthy control subjects.Results In 84 suspected HCV patients,the HCV-IgG positive rate was 84.5%,HCV-cAg positive rate was 13.1%,HCV-RNA positive rate was 52.4%.Among 71 cases of HCV-IgG positive patients,there were 35 cases with negative HCV-RNA,the false positive rate was 49.3%.In 11 cases of HCV-cAg positive patients,there were 5 cases with negative HCV-RNA,the false positive rate was 45.5%.In 44 cases of HCV-RNA positive diagnosis of hepatitis C patients,HCV-IgG false negative rate was 18.2%,HCV-cAg false negative rate was 86.4%.The false negative rate of combined detection of HCV-cAg and HCV-IgG was 13.6%,and the true positive rate was 100.0%.Conclusion HCV-cAg and HCV-IgG have certain false negative and false positive in laboratory diagnosis of HCV,combine these two methods,or joint with HCV-RNA detection,could reduce the rate of missed diagnosis.

Application of hepatitis C virus core antigen detection in hepatitis C Screening / 国际检验医学杂志

Objective To investigate the clinical significance of HCV core antigen (HCV-cAg )in hepatitis C screening. Methods From October 2014 to October 2015 ,a total of 8000 serum samples were collected from the outpatient and inpatient. HCV-cAg and hepatitis C antibody (HCV-Ab) were detected by using ELISA.The positive samples of HCV-cAg or HCV-Ab were performed the confirmative diagnostic detection by PCR.Results Among 8000 serum samples ,82 positive samples were screened out ,in which 73 cases were HCV-RNA positive by elementary screening with the standard of HCV-cAg or HCV-Ab positive ,a-mong which 72 were HCV-RNA positive and and 9 cases were HCV-RNA negative by HCV-RANA confirmation.The sensitivity and specificity of HCV-cAg were 45.83% and 99.98% ,sensitivity and specificity of HCV-Ab were 94.44% and 99.90% ,which of HCV-cAg and HCV-Ab combined detection were 100.00% and 98.86% respectively.Conclusion HCV-cAg and HCV-Ab play complementary role in HCV screening.Their combined detecting contributes to increase the screening rate of HCV.

Comparison the clinical value of three methods for diagnosis for hepatitis C / 国际检验医学杂志

Objective To compare the clinical value of hepatitis C virus (HCV)antibody(HCV-Ab),hepatitis C virus core anti-gen (HCV-cAg),hepatitis C virus ribonucleic acid (HCV-RNA)in diagnosis for hepatitis C.Methods A total of 258 patients with hepatitis C were recruited in this study,HCV-RNA was detected by fluorescence quantitative PCR detection,HCV-Ab and HCV-cAg were detected by the double antigen sandwich ELISA statutory,and the test data was analyze.Results The result of HCV-Ab detection was significant difference with those of HCV-cAg and HCV-RNA detection respectively(P 0.05).Conclusion The coincidence rate of HCV-cAg detection and HCV-RNA detection was high,and complement with HCV-Ab,the early detection could be done to prevent the omission of HCV infection and to improve the detection rate.