Hepatitis C is a liver disease caused by hepatitis C virus (HCV). HCV infection is generally asymptomatic during the acute phase and about 85% of them become chronically infected. However, most instances of acute infection are clinically undetectable. In rare cases, acute hepatitis is accompanied by jaundice, malaise, weakness and anorexia. Since HCV cannot be grown in the clinical laboratory, more sensitive molecular testing is needed to confirm the presence of the virus such as quantitative real-time PCR.

 

Intended Use

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

Features and Benefits

HCV Genotype Detection:	HCV genotype 1, 2, 3, 4, 5 and 6 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	Hepatitis C virus (5’ UTR)
Specimen Type	Serum, EDTA-plasma
Sensitivity (LoD)	20 IU/ml (genotype 1)
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® HCV Quantitative RT-PCR Kit includes serially diluted Standard Positive Control (SPC) 1~5 for the quantification of HCV.

 

Fig 3. Positive Sample (flu. graph)

Fig 4. Negative Sample (flu. graph)

 

AccuPower® HCV 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.