AccuPower® HIV-1 Quantitative RT-PCR Kit

AccuPower® HIV-1 Quantitative RT-PCR Kit is an in vitro diagnostic kit designed for the quantification of HIV-1 RNA in EDTA-plasma samples using Real-Time PCR.

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Cat. No.

HIV-1211

Product Description

AccuPower® HIV-1 Quantitative RT-PCR Kit is an in vitro diagnostic assay designed for the quantitative detection of HIV-1 RNA in EDTA plasma samples using real-time RT-PCR. Monitoring HIV-1 viral load is essential for establishing treatment strategies and evaluating therapeutic response in infected patients.

The kit provides sensitive and reliable quantification of HIV-1 RNA across diverse subtypes and has been internationally validated through regulatory certifications:

Cat. No. HIV-1111: WHO Prequalified
Cat. No. HIV-1211: CE List A certified

With these certifications, the AccuPower® HIV-1 Quantitative RT-PCR Kit is recognized for both global health program use (WHO PQ) and clinical diagnostic applications in Europe (CE-IVD List A).

The kit is intended for use on the ExiStation™ Universal Molecular Diagnostic System.

The standard workflow includes the AccuLoader™, a guided sample loader for contamination control.

Features and Benefits

HIV-1 Subtype Detection: HIV-1 subtype group M (A, B, C, D, AE, F, AG, G, H and several CRFs), N and O are detectable with high sensitivity.
Signature Convenience: One-step RT-PCR premix type. All components for the assay are contained within a tube.
Enhanced Sensitivity & Specificity: Bioneer’s proprietary Dual HotStart technology accomplishes high sensitivity and specificity
Remarkable Stability: Vacuum-dried premix allows stable and reproducible results
High Quality: Manufactured under strict quality control guidelines, and the product is certified WHO Prequalification for reliable and globally recognized diagnostics

Specifications

Specimen Type	EDTA-plasma
Kit Contents	PCR Premix, SPC 1~5, LPC, HPC, NTC, SL buffer, DEPC D.W.
Instrumentation	ExiStation™ Universal Molecular Diagnostic System
Tests	96

Performances

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AccuPower^® HIV-1 Quantitative RT-PCR Kit includes serially diluted Standard Positive Control (SPC) 1~5 for the quantification of HIV-1.

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AccuPower^® HIV-1 Quantitative RT-PCR Kit test results using clinical samples. The kit employs IPC in all wells to confirm correct PCR amplification.

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User centric ExiStation Manager software automatically analyzes the test results based upon the Ct (threshold cycle) value.

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The clinicla evaluation of AccuPower® HIV-1 Quantitative RT-PCR Kit in Cerba Specimen Services(France). Total 254 samples(234 ea HIV-1 positive/negative European specimens & 20 additional samples) were used.

Ordering Information

Cat. No.	Product Description	Certification
HIV-1211	AccuPower® HIV-1 Quantitative RT-PCR Kit (96 tests)	CE List A
HIV-1111	AccuPower® HIV-1 Quantitative RT-PCR Kit (96 tests)	WHO PQ

Related Products

Cat. No.	Instrument
A-5251	AccuLoader™
A-2060	Exicycler™ 96 Real-Time Quantitative Thermal Block
A-2200	ExiStation™ Universal Molecular Diagnostic System
A-5050	ExiPrep™16 Dx Automated Nucleic Acid Extraction System (16 tests)
Cat. No.	Nucleic Acid Extraction Kit
K-4471	ExiPrep™ Dx Viral DNA/RNA Kit (96 tests)
K-4473	ExiPrep™ Dx Viral RNA Kit (96 tests)

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