HCV-Q Real-Time PCR Kit

Product Overview

Hepatitis C Virus (HCV) is a blood-borne pathogen that primarily affects the liver and can progress from acute infection to chronic hepatitis, cirrhosis, liver failure, and hepatocellular carcinoma. Since a significant proportion of infected individuals remain asymptomatic for years, accurate molecular testing is essential for early detection, disease monitoring, and treatment evaluation.

The HCV-Q Real-Time PCR Kit from Genes2Me is a highly sensitive and specific molecular assay designed for the detection and quantification of HCV RNA in human serum and plasma samples. The assay provides reliable viral load measurements, supporting clinicians and researchers in monitoring disease progression and assessing antiviral treatment efficacy.

Targets:
Hepatitis C Virus (HCV RNA)
Technology:
One-Step Quantitative Real-Time RT-PCR (qRT-PCR)
Detection:
Quantitative (Viral Load in Copies/mL and IU/mL)
Sample Type:
Serum, Plasma
Certification:
Research Use Only (RUO)
HCV-Q RT-PCR Kit

How the Assay Works

The HCV-Q assay utilizes quantitative Reverse Transcription Real-Time PCR (qRT-PCR) technology with highly specific primers and fluorescent probes targeting conserved regions of the HCV genome. HCV-specific amplification is detected through the FAM channel, while an Internal Control monitored in the Cy5 channel validates nucleic acid extraction, amplification efficiency, and overall assay integrity.

The kit includes four Quantification Standards (QS1–QS4) with predefined copy numbers to generate a standard curve, enabling precise viral load quantification across a broad dynamic range. Ready-to-use reagents and a streamlined workflow ensure reproducible and dependable results.

Why Molecular Viral Load Testing Matters

HCV infection often remains undiagnosed until significant liver damage has occurred. Quantitative molecular testing provides direct measurement of circulating HCV RNA, offering the most reliable indicator of active infection and treatment response.
Regular HCV viral load monitoring supports:

  • Assessment of antiviral therapy effectiveness
  • Monitoring treatment response and viral clearance
  • Detection of virological relapse
  • Disease progression studies
  • Clinical and translational research applications

Sample Type & Reporting Output

Sample Type:
Serum, Plasma
Reporting Output:
Quantitative HCV RNA Viral Load
Targets Detected:
Hepatitis C Virus RNA
Detection Channels:
FAM (HCV), Cy5 (Internal Control)

Key Features & Benefits

Accurate viral load quantification

Accurate viral load quantification Enables precise measurement of HCV RNA levels in copies/mL and IU/mL for treatment monitoring and disease management.

Exceptional analytical performance

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

Sensitive low-level detection

Sensitive low-level detection Detects as low as 50 copies/mL (18.5 IU/mL), supporting early identification of active viral replication.

Built-in internal control

Built-in internal control Cy5-channel internal control validates extraction quality and amplification efficiency while minimizing false-negative results.

Quantification standards

Quantification standards included Four ready-to-use standards facilitate robust standard curve generation for accurate viral load determination.

High reproducibility

High reproducibility Precision studies demonstrate repeatability below 5% CV and reproducibility below 4% CV for consistent results.

No cross-reactivity observed

No cross-reactivity observed Validated against HIV, HBV, and HSV, ensuring high assay specificity and confidence in differential diagnosis.

Broad instrument compatibility

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

Applications

  • Clinical & Molecular Research Laboratories: Supports sensitive detection and quantification of HCV RNA for viral load monitoring and disease management studies.
  • Antiviral Therapy Monitoring: Provides accurate assessment of treatment response and supports evaluation of sustained virological response (SVR).
  • Chronic Hepatitis C Research: Facilitates longitudinal monitoring of viral kinetics and disease progression in HCV-infected populations.
  • Liver Disease & Hepatology Programs: Supports research involving chronic liver disease, fibrosis progression, and treatment outcome evaluation.
  • Public Health & Epidemiological Surveillance: Enables large-scale HCV monitoring initiatives and supports viral hepatitis elimination programs.
  • Academic & Translational Research: Generates reliable quantitative molecular data for HCV pathogenesis, virology, and therapeutic development studies.

Analytical Performance

  • Analytical sensitivity & specificity: 100%
  • Accuracy: 99%
  • Limit of Detection (LOD): 70 copies/mL (12 IU/mL)
  • Measuring range: 10–10⁹ copies/reaction
  • Linearity: R² = 0.991
  • Quantification standard slope: -3.56
  • Repeatability: CV < 5%
  • Reproducibility: CV < 4%
  • Ct cut-off: ≤ 35
  • No cross-reactivity with HIV, HBV, and HSV
  • 12-month shelf life under recommended storage conditions

    • Data Analysis and Report

    HCV-Q Real Time PCR Kit

    HCV-Q Real Time PCR specific amplification plot of HCV Positive Control (FAM Channel) along with Internal Control (Cy5 Channel)

    Ordering Information

    Commercial Name Old Cat No. New Cat No. Pack Size
    HCV-Q Real-Time PCR Kit G2MBR4-0076 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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