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 logIU/ml 3.37 (interquartile range logIU/ml 2.10-10.89) as compared to TRUPCR where it was logIU/ml 3.54 (interquartile range logIU/ml 2.67-11.52). A very good correlation was seen between the two assays (R = 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.