AccuPower® HBV Quant Kit (ExiStation™ FA 96)

AccuPower® HBV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of hepatitis B virus (HBV) DNA in human samples such as Serum and EDTA-plasma through Real-Time PCR.

Product Description

AccuPower® HBV Quant Kit (ExiStation™ FA 96) is an in vitro diagnostic kit designed for the quantification of HBV DNA in EDTA-plasma or Serum samples using Real-Time PCR, and is fully compatible with ExiStation™ FA 96.

When used with ExiStation™ FA 96, the system enables the processing of up to 96 samples within 120 minutes, supporting high-throughput testing.

The kit provides sensitive and reliable quantification of HBV DNA, developed based on Bioneer's technology and experience.

Cat. No. HBV-3116 (for ExiStation™ FA 96): Asia's first CE-IVDR Class D

Features and Benefits

Various HBV Genotype Detection: HBV Genotype A, B, C, D, E, F, G, H are detectable with high sensitivity
Broad Quantification Range: Enables quantification of HBV Genotype DNA from 10 IU/mL to 10⁸ IU/mL
High Sensitivity & Specificity: Bioneer’s proprietary Dual-HotStart™ technology with UDG ensures high detection performance
Enhanced Convenience & Stability: Ready-to-use premixed kit with extended shelf life, enabling room temperature shipping
System Compatibility: Compatible with the fully automated molecular diagnostic system, ExiStation™ FA 96, improving workflow efficiency

Specifications

Specimen Type	EDTA-plasma, Serum
Kit Contents	PCR Premix, SPC, LPC, HPC, NTC, Sealing film
Instrumentation	ExiStation™ FA 96
Tests/kit	96

Performances

AccuPower® HBV Quant Kit (ExiStation™ FA 96) includes negative control and positive controls to verify the validity of the experiment.

HBV-3116 SPC

AccuPower® HBV Quant Kit (ExiStation™ FA 96) includes calibrator to verify the linearity of the experiment

HBV-3116 Targetgraph

AccuPower® HBV Quant Kit (ExiStation™ FA 96) test results for clinical samples. An internal Positive control is used to validate the PCR results of each specific sample

HBV-3116 Software

AccuPower® HBV Quant Kit (ExiStation™ FA 96) test results for clinical samples. An internal Positive control is used to validate the PCR results of each specific sample

HBV-3116 ClinicalEvaluation

Clinical Sensitivity = 100.0% (95% CI: 97.0 to 100.0)
Clinical Specificity = 99.2% (95% CI: 95.6 to 99.9)

Clinical evaluation of the AccuPower® HBV Quant Kit (ExiStation™ FA 96) was conducted using 250 residual clinical specimens collected in Europe.

Ordering Information

Cat. No.	Product Description	Certification
HBV-3116	AccuPower® HBV Quant Kit (ExiStation™ FA 96)	CE-IVDR Class D

Related Products

Cat. No.	Instrument
A-2500-1	ExiStation™ FA 96
Cat. No.	Nucleic Acid Extraction Kit
K-4814	ExiStation™ FA DNA/RNA Kit(V2)

Quality Assurance

Bioneer is the holder of Quality Management System Certificates for the following standards.

ISO 13485 - certificate

Contact Us

E-mail : sales@bioneer.com

v0.0 / 2019-03-05