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Hepatitis C virus core antigen: A diagnostic and treatment monitoring marker of hepatitis C virus in Indian population

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Abstract

Background

The diagnosis and treatment monitoring of hepatitis C is quite challenging. The screening test, i.e. antibody assay, is unable to detect acute cases, while the gold standard hepatitis C virus (HCV) reverse transcriptase polymerase chain reaction (RTPCR) assay is not feasible in resource-limited countries such as India due to high cost and infrastructure requirement. European Association for the Study of the Liver and World Health Organization have approved a new marker, i.e. HCV core antigen (HCVcAg) assay, as an alternative to molecular assay. In this study, we have evaluated HCVcAg assay for diagnosis and treatment monitoring follow-up in Indian population infected with hepatitis C.

Methods

Blood specimen of 90 clinically suspected cases of acute hepatitis C were tested simultaneously for anti-HCV antibody assay via ELISA (enzyme-linked immunoassay), HCVcAg assay by chemiluminescence immune assay (CLIA) and HCV RTPCR VL (viral load) assay. Thirty-four HCV RTPCR positive patients were further enrolled in treatment monitoring group whose blood samples were tested at the beginning of treatment, two weeks, four weeks and 12 weeks via HCV core Ag assay and HCV RTPCR Viral Load assay.

Results

Considering HCV RTPCR as gold standard, diagnostic performance of HCV core Ag assay and anti-HCV antibody assay was evaluated. The sensitivity and specificity of HCV core Ag assay were higher than that of anti-HCV Antibody assay, i.e. 88.3% and 100% vs. 23.3% and 83.3%, respectively. The overall diagnostic accuracy of HCV core Ag assay was 92.20%. Among treatment follow-up group, HCV core Ag levels correlated well with HCV viral load levels, at the beginning of treatment (baseline) till 12 weeks showing highly significant Spearman rank correlation coefficient of > 0.9 with HCV viral load levels.

Conclusions

HCV core Ag assay is a cost-effective, practically feasible substitute of HCV RTPCR viral load assay for diagnosis as well as long duration treatment monitoring of hepatitis C infection in resource-limited settings.

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Acknowledgements

We would like to acknowledge Dr Vikram Singh, Additional Professor, Department of Medicine, Dr RMLIMS, Lucknow, for his administrative help in conducting the study.

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Authors and Affiliations

  1. Department of Microbiology, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, 226 010, India

    Jaya Garg, Anupam Das & Jyotsna Agarwal

  2. Department of Gastromedicine, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, 226 010, India

    Prashant Verma

  3. Department of Medicine, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, 226 010, India

    Mridu Singh

  4. Department of Community Medicine, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, 226 010, India

    Anurag Pathak

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  1. Jaya Garg
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Contributions

Jaya Garg: conceptualized and did overall supervision of the study. Prashant Verma: clinical analysis of admitted patients. Mridu Singh: helped in clinical evaluation and follow-up of enrolled patients. Anupam Das: laboratory testing and analysis. Anurag Pathak: compiled the data and calculated the statistical results of the study. Jyotsna Agarwal: helped in treatment monitoring of patients. I/we affirm that the submission represents original work that has not been published previously and is not currently being considered or submitted to another journal, until a decision has been made. Also, we confirm that each author has seen and approved the contents of the submitted manuscript. This manuscript has the permission from the institutional IRB.

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Correspondence to Jaya Garg.

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Competing interests

JG, PV, MS, AD, AP and JA  declare no competing interests. 

Ethics statement

The study was performed conforming to the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.

Ethical approval

Ethical approval has been granted by Institute ethical committee(IEC-No 26/19).

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All subjects enrolled in the study have given written consent to participate in study.

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All authors have seen and approved the contents of the submitted manuscript and given the consent for publication.

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The authors are solely responsible for the data and the content of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members, the Indian Society of Gastroenterology or the printer/publishers are responsible for the results/findings and content of this article.

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Garg, J., Verma, P., Singh, M. et al. Hepatitis C virus core antigen: A diagnostic and treatment monitoring marker of hepatitis C virus in Indian population. Indian J Gastroenterol (2024). https://doi.org/10.1007/s12664-024-01549-7

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