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Performance evaluation of TRUPCR® HBV Real-time PCR assay for Hepatitis B virus DNA quantification in clinical samples: report from a tertiary care liver centre

  • Sujata Lall
  • Manish C. Choudhary
  • Supriya Mahajan
  • Guresh Kumar
  • Ekta GuptaEmail author
Original Article
  • 6 Downloads

Abstract

Quantitative Real-time PCR (qPCR) based Hepatitis B virus (HBV) DNA load estimation is crucial for the initiation of treatment and serves as a strong predictor of liver disease progression in HBV infected individuals. HBV DNA quantification has been ever evolving with the addition of new qPCR based kits on a regular basis. The study was carried with an objective to evaluate the performance characteristics of a commercially available qPCR kit (TRUPCR®, 3B Black Bio Biotech, India Ltd.) and compare with CE approved qPCR kit (Artus HBV Real-time PCR, Qiagen, Germany). 121 HBV infected patients were prospectively enrolled from July to December 2016. Aliquots of serum samples were tested in parallel by TRUPCR® and Artus for HBV DNA levels. Genotype D was most predominant genotype in 36.9% (38/121) of patients followed by genotype A in 14.6% (15/121) patients. Median viral load as seen by Artus was log10IU/ml 3.37 (interquartile range log10IU/ml 2.10–10.89) as compared to TRUPCR® where it was log10IU/ml 3.54 (interquartile range log10IU/ml 2.67–11.52). A very good correlation was seen between the two assays (R2 = 0.964) with a concordance rate of 92.6% (112/121). The TRUPCR® qPCR HBV kit is capable of providing reliable and rapid HBV DNA quantitation and together with its much lower costs, presents itself as a good alternative.

Keywords

HBV DNA quantification TRUPCR® Real-time PCR 

Notes

Acknowledgements

Dr. Tarun and Mr. Prateek from Black biotech for technical support; Mr. Gaurav Singh for performance of various tests. This research received no specific Grant from any funding agency, commercial or not-for profit sectors.

Compliance with ethical standards

Conflict of interest

None declared.

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Copyright information

© Indian Virological Society 2019

Authors and Affiliations

  • Sujata Lall
    • 1
  • Manish C. Choudhary
    • 1
  • Supriya Mahajan
    • 1
  • Guresh Kumar
    • 2
  • Ekta Gupta
    • 1
    Email author
  1. 1.Department of Clinical VirologyInstitute of Liver and Biliary SciencesNew DelhiIndia
  2. 2.Department of Clinical ResearchInstitute of Liver and Biliary SciencesNew DelhiIndia

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