AccuPower® HIV-1 Quant Kit (ExiStation™ FA 96)

AccuPower® HIV-1 Quant Kit (ExiStation™ FA 96) is an in vitro diagnostic kit designed for the quantification of HIV-1 RNA in EDTA-plasma samples using Real-Time PCR.

Product Description

AccuPower® HIV-1 Quant Kit (ExiStation™ FA 96) is an in vitro diagnostic kit designed for the quantification of HIV-1 RNA in EDTA-plasma 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 HIV-1 RNA, developed based on Bioneer's technology and experience from WHO Prequalification HIV-1 Kit :

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

Features and Benefits

Reliable Viral Load Monitoring: Enables quantification of HIV-1 RNA from 50 IU/mL to 10⁸ IU/mL
True Full Automation: Compatible with ExiStation™ FA 96, delivering a streamlined workflow from de-capping & re-capping through extraction to PCR
Fast Turnaround Time: 96 results/hour after initial 120 mins run
Comprehensive HIV-1 Subtypes Coverage: HIV-1 subtype Group M (A-H, and several CRFs), Group N and Group O are detectable with high sensitivity
High Sensitivity & Specificity: Bioneer’s proprietary Dual-HotStart™ technology with UDG ensures high detection performance
Enhanced Convenience & Stability: Ready-to-use premixed kit with 24 months shelf life, enabling room temperature shipping

Specifications

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

Performances

HIV-3116 NTCPC Graph_1

AccuPower® HIV-1 Quant Kit (ExiStation™ FA 96) enables quantitative detection of HIV-1 RNA from 50 IU/mL to 10⁸ IU/mL.

HIV-3116 Clinical evaluation

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

The clinical evaluation of the AccuPower® HIV-1 Quant Kit (ExiStation™ FA 96) was conducted using 250 residual clinical specimens collected in Europe.

Ordering Information

Cat. No.	Product Description	Certification
HIV-3116	AccuPower® HIV-1 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