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DI Hepatitis B Virus - Viral Load Quantification (DIHBV-VLQ)
- Duplex real-time qPCR A viral load quantification kit and an exogenous internal control.
- Viral load quantification Supplied with a 4-point calibration curve (2×10⁶ IU/mL to 2×10³ IU/mL), calibrated against the WHO international standard and quantified by digital PCR. LoD: 10 IU/mL.
- Various sample types For blood samples (serum or plasma).
- Aligned with WHO thresholds Enables identification of patients requiring treatment (≥ 2,000 IU/mL) as well as pregnant women at risk of transmission (≥ 200,000 IU/mL).
- Accessible Developed with the constraint of delivering a high-performance test at an affordable cost.
- Flexible Easy to use and rapid (1 hour after extraction). Room-temperature transportable (lyophilized). Compatible with different thermocyclers (validated on CFX and QS5/7 Pro).
Learn more
The DI HBV Duplex Viral Load Quantification Kit (DIHBV-VLQ) is an in vitro diagnostic medical device, based on real-time PCR technology, intended for the quantification of hepatitis B virus (HBV) DNA (genotypes A to G).
This test is designed for use with human EDTA plasma or serum samples, following prior extraction of nucleic acids (NA) using validated methods, either described in this instructions for use or validated internally by the laboratory. It can be implemented on open real-time PCR platforms validated for this purpose.
It is intended for use in monitoring viral load in patients with confirmed chronic hepatitis B virus infection in the following situations:
- Quantification of viral load to assess viral activity
- Evaluation of the risk of perinatal (mother-to-child) transmission
- Monitoring and assessment of the effectiveness of anti-hepatitis B treatment
Results are expressed in International Units per milliliter (IU/mL) in accordance with WHO international standards.
Features
| Samples | EDTA Plasma and serum |
| Targets | HBV andNTPC |
| Controls | Target Positive Amplification Control (PAC) and Exogenous control |
| Duration | ~ 1h00 |
| Equipment | Validated on CFX and QS5 |
| Stability | 24 monthes |
| Storage temperature | From -16°C to -26°C |
| Shipment temperature | Ambiant |
| Reference | DIHBV-VLQ-50 |
