Human immunodeficiency virus (HIV) is recognized as a known viral agent that causes Acquired Immune Deficiency Syndrome (AIDS). Thus, monitoring of viral load in HIV-1 infection patients is an essential test for establishment of therapeutic strategy and determination of therapeutic progress. A RT (Reverse transcriptase) PCR test is used to measure the amount of HIV RNA. Because this test looks for HIV directly in a person's blood instead of detecting antibodies, it is used by researchers and health care providers to identify infections during the window period.

 

Intended Use

The AccuPower® HIV-1 Quantitative RT-PCR Kit is an in vitro diagnostic kit designed for the quantification of human immunodeficiency virus type 1 (HIV-1) RNA in human samples such as EDTA-plasma through real-time PCR using ExiStation™ Molecular Diagnostic System.

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. Just add sample!
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:	All diagnostic kits manufactured by Bioneer are under strict quality control guidelines.

 

Specifications

Target	Human immunodeficiency virus type 1 (integrase region of polymerase gene)
Specimen Type	EDTA-plasma
Sensitivity	LoD: 33.9 IU/ml (subtype B) LoQ: 100 IU/ml
Kit Contents	PCR Premix, SPC 1~5, LPC, HPC, NTC, SL buffer, DEPC D.W.
Instrumentation	ExiStation™ Universal Molecular Diagnostic System
Tests	96

 

Experimental Data

Fig 1. Standard Positive Control (flu. graph)

Fig 2. Standard Curve

 

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

 

Fig 3. Positive Sample (flu. graph)

Fig 4. Negative Sample (flu. graph)

 

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

 

Fig 5. Final Results

 

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