Sansure HBV Ultra Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit, for 48 Rxns

The Sansure HBV Ultra Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit is a high-performance in vitro nucleic acid amplification test designed for the quantification of HBV DNA in human serum or plasma. By employing advanced magnetic beads technology and a robust PCR fluorescence probing method, this kit delivers reliable, sensitive, and accurate results for HBV diagnosis and monitoring treatment efficacy.

Key Features

1. Advanced Magnetic Beads Technology:

• Efficient and precise extraction of HBV DNA from plasma using advanced magnetic bead technology.
• Ensures high sensitivity and wide linear range detection to support clinical diagnostic and follow-up needs.

2. Highly Conservative Primer and Probe Design:

• Targets the highly conserved S gene of HBV, enabling accurate detection across A–H genotypes.
• Reduces the risk of missed detection in diverse patient populations.

3. Comprehensive Quality Control System:

• Incorporates a UNG enzyme + dUTP system to eliminate carry-over contamination, minimizing false-positive results.

4. Internal Control Integration:

• Uses pseudoviruses as an Internal Control to monitor the entire HBV extraction and amplification process.
• Ensures reliable detection by reducing the risk of false-negative results.

Product Performance

Applications and Use Cases

1. Clinical Diagnostics:

• HBV Infection Detection:
  • Quantify HBV DNA levels for diagnosing active infections.
• Genotype Coverage:
  • Comprehensive detection across all A–H genotypes ensures reliability in diverse patient groups.

2. Treatment Monitoring:

• Therapeutic Efficacy Assessment:
  • Measure HBV DNA viral load to monitor the response to antiviral therapies.
• Long-Term Patient Follow-Up:
  • Evaluate disease progression and the risk of complications such as liver cirrhosis or hepatocellular carcinoma.

3. Public Health and Research:

• Epidemiological Studies:
  • Monitor HBV prevalence and transmission dynamics across populations.
• Clinical Research:
  • Assess the effectiveness of new therapeutic agents targeting HBV replication.

Advantages of Sansure HBV Ultra

1. High Sensitivity and Precision:
   • Detects as low as 5 IU/mL, providing accurate quantification even at low viral loads.
2. Wide Linear Detection Range:
   • Offers a dynamic range from 20 IU/mL to 2.0 × 10⁹ IU/mL, suitable for both acute and chronic HBV infections.
3. Minimized Contamination Risks:
   • UNG enzyme and dUTP system prevent carry-over contamination, ensuring result accuracy.
4. Comprehensive Quality Control:
   • Internal Control ensures the reliability of the entire process, from DNA extraction to amplification.
5. User-Friendly Design:
   • Compatible with widely used PCR instruments, including SLAN-96P, ABI7500, and Roche Cobas 480, simplifying integration into existing workflows.
6. Regulatory Compliance:
   • CE-certified, meeting stringent quality and performance standards for clinical diagnostics.

Procedure Workflow

1. Sample Collection:
   • Use human plasma as the specimen type.
2. DNA Extraction:
   • Employ advanced magnetic beads technology to extract HBV DNA efficiently.
3. PCR Amplification:
   • Perform amplification using compatible instruments, such as SLAN-96P or ABI7500.
4. Quantitative Analysis:
   • Measure fluorescence signals to calculate HBV DNA levels based on the standard curve.

Storage and Stability

• Store the kit components as per the manufacturer’s instructions to ensure performance reliability.
• Avoid repeated freeze-thaw cycles for reagents to maintain integrity.

The Sansure HBV Ultra Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit combines cutting-edge magnetic beads technology, robust primer/probe design, and comprehensive quality controls to deliver accurate, sensitive, and reproducible results. It is an invaluable tool for diagnosing HBV infections, monitoring disease progression, and assessing therapeutic efficacy.