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QuantPrime HBV
Intended Use

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.

Features

Ultra-High Sensitivity

Achieves an exceptional limit of detection down to 3 IU/mL to ensure precise monitoring of low-level viremia.


Dual Target Genes

Targets highly conserved regions of both the S and preC/C genes to significantly minimize the risk of false-negative results.


Comprehensive Genotype Coverage

Robustly detects all major HBV genotypes from A - I for broad global clinical applicability.


Advanced Anti-Contamination

Integrates a UNG enzyme system and a WHO-traceable internal standard to deliver highly reliable and contamination-free quantitative results.


Specifications

Name

QuantPrime HBV

Technology / Methodology

PCR Fluorescent Probe / Magnetic particles extraction

Specimen Type

Plasma, Serum

Sample Input Volume

200 μL/ 500 μL

Genotype

Genotypes A, B, C, D, E, F, G, H, and I

Limit of Detection (LoD)

5 IU/mL (200 μL extraction)

3 IU/mL (500 μL extraction)

Linear Range

10 IU/mL to 2.00E+08 IU/mL

Precision

CV ≤ 5%

Internal Control

Yes

Storage Conditions

2-8°C


Ordering Information

Cat. No.

Product Name

Spec.

Certificate

M1041

QuantPrime HBV

48 Tests/Kit

NMPA

M1042

96 Tests/Kit

NMPA

M1043

192 Tests/Kit

NMPA