HBV Viral Load

Quantitative Real-Time PCR Assay for HBV DNA

The TRUPCR^® HBV Viral Load Kit is a high-precision in-vitro nucleic acid amplification assay designed for the quantitative detection of Hepatitis B Virus (HBV) DNA. Utilizing advanced Real-Time PCR technology, this assay is a critical tool for clinical diagnosis, treatment initiation, and therapeutic monitoring.

By targeting the highly conserved S gene, the assay provides comprehensive coverage across all HBV genotypes, from A to J. The kit features a dual-channel multiplex design, processing two independent reactions in parallel: the viral target is detected in the FAM/Green channel, while an endogenous internal control is monitored in the HEX/VIC/Yellow channel to validate both extraction efficiency and PCR amplification.

Key Features and Performance

• Superior Sensitivity: Provides a Lower Limit of Detection (LoD) of 2.5 IU/ml.
• Broad Genotypic Coverage: Accurately quantifies HBV genotypes A, B, C, D, E, F, G, H, I, and J.
• Standardized Calibration: Calibrated against the 5^th WHO International Standard (NIBSC code: 22/120) for consistent Hepatitis B Virus DNA NAT reporting.
• Advanced PCR Chemistry:
• Hot-Start Technology: Minimizes non-specific amplification to maximize sensitivity and specificity.
• Contamination Control: Includes Uracil-N-Glycosylase (UNG) in the master mix to prevent carry-over contamination.
• Robust Quality Assurance: The endogenous internal control provides a comprehensive check for both the extraction process and PCR inhibition.
• Streamlined Workflow: Designed for ease of use and validated for compatibility with a wide range of leading Real-Time PCR instruments.
• High Specificity: Demonstrated zero cross-reactivity with other common pathogenic viruses, bacteria, or fungi.

Selected Peer-Reviewed Publications

·      Bag S, Ghosh S, Lalwani R, Vishnoi P, Gupta S, Dubey D. Real-Time Polymerase Chain Reaction-Based Detection and Quantification of Hepatitis B Virus DNA. J Vis Exp. 2023 Dec 15;(202). doi: 10.3791/66249. PMID: 38163269.

·      Lall S, Choudhary MC, Mahajan S, Kumar G, Gupta E. 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. Virusdisease. 2019 Jun;30(2):186-192. doi: 10.1007/s13337-018-0502-0. Epub 2019 Jan 5. PMID: 31179355; PMCID: PMC6531600.

·      Garg G, Meenu MN, Patel K, Singh R, Gupta P, Purwar S, Mukhopadhyay S, Mishra N, Gupta S, Rawat SK, Goel H, Kumar R, Tanwar P, Singh J, Nema S, Biswas D, Trehanpati N, Singh AK, Vyas AK. Presence of entry receptors and viral markers suggest a low level of placental replication of hepatitis B virus in a proportion of pregnant women infected with chronic hepatitis B. Sci Rep. 2022 Oct 22;12(1):17795. doi: 10.1038/s41598-022-22699-8. PMID: 36272995; PMCID: PMC9588053.