HBV-Q Real-Time PCR Kit

Product Overview

Hepatitis B Virus (HBV) is a major global public health concern and one of the leading causes of chronic liver disease, cirrhosis, and hepatocellular carcinoma. Accurate viral load monitoring plays a critical role in assessing disease progression, guiding antiviral therapy, and evaluating treatment response.

The HBV-Q Real-Time PCR Kit from Genes2Me is a highly sensitive and specific molecular assay designed for the detection and quantification of HBV DNA in human serum and plasma samples. The assay provides precise viral load measurements, enabling laboratories to support disease monitoring and therapeutic decision-making with confidence.

Targets:
Hepatitis B Virus (HBV DNA)
Technology:
Quantitative Real-Time PCR (qPCR)
Detection:
Quantitative (Viral Load in Copies/mL and IU/mL)
Sample Type:
Serum, Plasma
Certification:
Research Use Only (RUO)
HBV-Q RT-PCR Kit

How the Assay Works

The HBV-Q assay utilizes quantitative Real-Time PCR (qPCR) technology with highly specific primers and fluorescent probes targeting conserved regions of the HBV genome. HBV-specific amplification is detected through the Texas Red channel, while a built-in Internal Control monitored in the Cy5 channel validates nucleic acid extraction, amplification efficiency, and overall assay performance.

The kit includes four Quantification Standards (QS1–QS4) with predefined concentrations to generate a robust standard curve, enabling accurate calculation of HBV viral load across a wide dynamic range. Ready-to-use reagents and a streamlined workflow ensure consistent and reliable results.

Why Molecular Viral Load Testing Matters

HBV infection may remain asymptomatic for years while progressively damaging the liver. Quantitative molecular testing provides direct measurement of circulating viral DNA, offering valuable insights into infection activity and treatment effectiveness.
Regular HBV viral load monitoring supports:

  • Assessment of antiviral therapy response
  • Early detection of virological breakthrough
  • Monitoring disease progression
  • Risk stratification for chronic HBV patients
  • Longitudinal patient management and clinical research

Sample Type & Reporting Output

Sample Type:
Serum, Plasma
Reporting Output:
Quantitative HBV DNA Viral Load
Targets Detected:
Hepatitis B Virus DNA
Detection Channels:
Texas Red (HBV), Cy5 (Internal Control)

Key Features & Benefits

Accurate viral load quantification

Accurate viral load quantification Enables precise measurement of HBV DNA levels in copies/mL and IU/mL for treatment monitoring.

High analytical performance

High analytical performance Delivers 100% analytical sensitivity and specificity, ensuring reliable detection across diverse viral loads.

Sensitive low-level detection

Sensitive low-level detection Detects as low as 70 copies/mL (12 IU/mL), supporting early identification of active viral replication.

Integrated internal control

Integrated internal control Cy5-channel internal control verifies extraction quality and PCR efficiency while reducing the risk of false-negative results.

Quantification standards

Quantification standards included Four ready-to-use standards facilitate accurate standard curve generation and viral load calculation.

Excellent reproducibility

Excellent reproducibility Precision studies demonstrate repeatability and reproducibility with coefficient of variation below 4%.

No cross-reactivity observed

No cross-reactivity observed Validated against HIV, HCV, and HSV with no cross-reactivity, ensuring high assay specificity.

Broad platform compatibility

Broad platform compatibility Validated on RapiCycler 96, Bio-Rad CFX96, QuantStudio™ 5, and LightCycler® 480 systems.

Applications

  • Clinical & Molecular Diagnostic Laboratories: Supports accurate quantification of HBV DNA for routine viral load monitoring and disease management studies.
  • Antiviral Therapy Monitoring: Enables assessment of treatment efficacy and longitudinal monitoring of patients receiving antiviral therapy.
  • Chronic Hepatitis B Research: Facilitates studies evaluating viral kinetics, disease progression, and therapeutic outcomes.
  • Liver Disease Management Programs: Provides quantitative data supporting risk assessment and monitoring of patients with chronic liver disease.
  • Public Health & Epidemiological Studies: Supports HBV surveillance programs and population-based viral hepatitis research initiatives.
  • Academic & Translational Research: Generates reliable quantitative molecular data for HBV pathogenesis, virology, and therapeutic research.

Analytical Performance

  • Analytical sensitivity & specificity: 100%
  • Clinical accuracy: 99%
  • Limit of Detection (LOD): 70 copies/mL (12 IU/mL)
  • Measuring range: 10–10⁹ copies/reaction
  • Linearity: R² = 0.999
  • Quantification standard slope: -3.47
  • Repeatability: CV < 4%
  • Ct cut-off: ≤ 35
  • Reproducibility: CV < 3.5%
  • No cross-reactivity with HIV, HCV, and HSV
  • 12-month shelf life under recommended storage conditions

    • Data Analysis and Report

    HBV-Q Real-Time PCR Kit

    HBV-Q Real Time PCR specific amplification plot of HBV Positive Control (TEXAS RED Channel) along with Internal Control (Cy5 Channel)

    Ordering Information

    Commercial Name Old Cat No. New Cat No. Pack Size
    HBV-Q Real-Time PCR Kit G2MBR4-0006 50 Tests

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    Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

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