• Sample Type: Human Plasma, Serum, Whole blood, tissue biopsy and other body fluids
• Fast: The extraction process completes in 1 hr 20 mins
• Compatibility: The DiAGSure® Hepatitis C Viral Load Kit is compatible with a broad range of real-time PCR platforms
• Specificity: The target sequences detected in this kit specifically targets the conserved 5’-UTR of HCV covering all 6 genotypes (1-6)
• Sensitivity: The analytical sensitivity of the assay was obtained using a dilution series of quantified in-vitro transcribed HCV 5’-UTR RNA spiked in negative plasma sample as a template for detection
• Precision: It is calculated based on intra-assay and inter-assay variability of the lowest copy number kit quantitative standard
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. The virus can cause both acute and chronic hepatitis, ranging in severity from a mild illness to a serious, lifelong illness including liver cirrhosis and cancer. The symptoms can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine and yellowing of the skin or eyes (jaundice). The hepatitis C virus is a bloodborne virus and most infection occur through exposure to blood from unsafe injection practices, unsafe health care, unscreened blood transfusions, injection drug use and sexual practices that lead to exposure to blood. Globally, an estimated 58 million people have chronic hepatitis C virus infection, with about 1.5 million new infections occurring per year. There are an estimated 3.2 million adolescents and children with chronic hepatitis C infection. There is no vaccine for hepatitis C, but it can be treated with antiviral medications. Early detection and treatment can prevent serious liver damage and improve long-term health. HCV has six genotypes, labeled 1 through 6. HCV genotype 1 may represent a more aggressive strain and one that is less likely to respond to interferon treatment than HCV genotype 2 or 3.
The DiAGSure® Hepatitis-C Viral Load Kit is an in vitro diagnostic (IVD) real-time reverse transcriptase polymerase chain reaction (qRT-PCR) test involving TaqMan chemistry intended for the quantitative detection of Hepatitis C virus RNA in human serum or plasma. A highly conserved region in the viral 5’ UTR sequence has been targeted. The kit covers HCV genotypes 1-6. This two-plex PCR includes an RNase-P internal control (IC) in a single- tube reaction.
Cap | Contents | Description | GDQ2042- 20R | GDQ2042- 50R | GDQ2042- 100R |
Red | UNG+ OS Master Mix | Enzyme Mix | 100 µL | 240 µL | 500 µL |
Amber | Primer-Probe Mix | Amplification Reagent | 50 µL | 120 µL | 250 µL |
Yellow | HCV Standard 1 | Quantification Standard | 50 µL | 100 µL | 200 µL |
Yellow | HCV Standard 2 | Quantification Standard | 50 µL | 100 µL | 200 µL |
Yellow | HCV Standard 3 | Quantification Standard | 50 µL | 100 µL | 200 µL |
Yellow | HCV Standard 4 | Quantification Standard | 50 µL | 100 µL | 200 µL |
Blue | Negative Control (NC) | Negative Control | 200 µL | 500 µL | 1 mL |
White | RNA Dilution Buffer | Tris-based buffer | 200 µL | 500 µL | 1 mL |
There are four quantification standards provided with the kit with viral RNA copies as follows:
Standard | IU/μL |
HCV Standard 1 | 104 |
HCV Standard 2 | 103 |
HCV Standard 3 | 102 |
HCV Standard 4 | 101 |
Fig: HCV standard curve plotted using DiAGSure HCV quantitation standards
A plot of Ct value vs DNA IU of the standards will fetch an equation wherefrom the viral copy number of an unknown sample can be deduced from its Ct value. The quantification standards exhibit linearity when Ct values are plotted against log (IU/ μL) with R2 value>0.99. The efficiency of amplification should be above 80% with the slope of the standard curve in the range -3.1 to -3.8.
The quantitation standards are defined as IU/μL prepared in accordance with 6th WHO International Standard for HCV DNA for NAT (NIBSC Code: 18/184). The following equation has to be applied to convert the values determined using the standard curve into IU/ml of sample material:
The conversion factor between HCV RNA copies/mL and HCV International Units/mL (IU/mL) is 4.4 copies/IU.
25 Reaction
₹ POR
50 Reaction
₹ POR
100 Reaction
₹ POR
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