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.

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.