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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

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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.

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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.

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Authors and Affiliations

  1. Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, 110070, India

    Sujata Lall, Manish C. Choudhary, Supriya Mahajan & Ekta Gupta

  2. Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, 110070, India

    Guresh Kumar

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  1. Sujata Lall
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  2. Manish C. Choudhary
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  3. Supriya Mahajan
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  5. Ekta Gupta
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Correspondence to Ekta Gupta.

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Lall, S., Choudhary, M.C., Mahajan, S. et al. 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. VirusDis. 30, 186–192 (2019). https://doi.org/10.1007/s13337-018-0502-0

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