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

  • Kannan, Ayswarya1
  • Biswas, Lalitha2
  • Kumar, Anil1
  • Kurian, Jessy3
  • S.Nair, Anjaly4
  • Suresh, Parasmal2
  • Sadasivan, Shine5
  • Biswas, Raja2
  • 1 Amrita Vishwa Vidyapeetham, Amrita Institute of Medical Sciences, Department of Microbiology, Ponekara, Kochi, Kerala, India.
  • 2 Amrita Vishwa Vidyapeetham, Center for Nanoscience and Molecular Medicine, Ponekara, Kochi , Kerala, India.
  • 3 Amrita Vishwa Vidyapeetham, Amrita Institute of Medical Sciences, Molecular biology laboratory, Ponekara, Kochi , Kerala, India.
  • 4 Amrita Vishwa Vidyapeetham, Amrita Institute of Medical Sciences, Department of Biostatistics, Ponekara, Kochi, Kerala, India.
  • 5 Amrita Vishwa Vidyapeetham, Amrita Institute of Medical Sciences, Department of Gastroenterology, Ponekara, Kochi, Kerala, India.
Published Article
Revista da Sociedade Brasileira de Medicina Tropical
Sociedade Brasileira de Medicina Tropical - SBMT
Publication Date
Feb 10, 2021
DOI: 10.1590/0037-8682-0253-2020
PMID: 33605377
PMCID: PMC7891558
PubMed Central


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.

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