This assay is intended for the in vitro quantitative detection of hepatitis B virusdeoxyribonucleic acid (HBV DNA) in human plasma/serum. This product can be used toevaluate the response to antiviral therapy and monitor treatment effectiveness by monitoringthe baseline level of HBV nucleic acid in the blood of patients with hepatitis B and changes inhepatitis B virus nucleic acid levels during treatment.The test results of this product should not be used as the sole indicator for assessing thepatient's condition and must be analyzed in combination with the patient's clinicalmanifestations and other laboratory tests. This assay is not intended for donor screening.
Ease of use
World's first ready‑to‑use lyophilized reagent for viral load testing
Quant by Internal Control
No additional reagent consumption required, with traceability to International Standards
Dual Anti‑Contamination System
UNG/dUTP carryover prevention & Mineral oil seal
Dual‑Target Detection
Dual‑target (S + preC/C gene) detection reduces false negatives and covers all 9 HBV genotypes (A‑I).
| Method | Real‑time PCR (Fluorescent Probe) |
| Target | HBV DNA (S gene + preC/C gene, dual target) |
| Linear Range | 10 IU/mL – 2.00×10⁸ IU/mL |
| Limit of Detection (LoD) | 5 IU/mL (200 μL sample); 3 IU/mL (500 μL sample) |
| Limit of Quantitation (LoQ) | 10 IU/mL |
| Detectable Genotypes | A, B, C, D, E, F, G, H, I (9 genotypes) |
| Sample Type | Plasma (EDTA) / Serum |
| Sample Volume | 200 μL / 500 μL |
| Precision (CV) | ≤5% |
| Storage Conditions | 2‑8°C, protected from light |
| Shelf Life | 24 months |
Cat. No. | Product Name | Spec. | Certificate |
M1041 | Molvizon HBV | 48 Tests/Kit | NMPA |
M1042 | 96 Tests/Kit | NMPA | |
M1043 | 192 Tests/Kit | NMPA |
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