Sample Type: Human Plasma, Serum, Whole blood, tissue biopsy and other body fluids
Fast: The extraction process completes in 1 hr 10 mins
Compatibility: The DiAGSure® Hepatitis B Viral Load Kit is compatible with a broad range of real-time PCR platforms
Specificity: The target sequences detected in this kit specifically target HBV’s pre-core/core gene.
Sensitivity: The analytical sensitivity of the assay was obtained using a dilution series of quantified cloned DNA spiked in a negative plasma sample as a template for detection
Precision: Precision was calculated based on intra-assay and inter-assay variability of the lowest copy number kit quantitative standard (HBV Standard 4) for HBV detection (FAM channel).
Hepatitis B is a serious liver infection caused by the hepatitis B virus (HBV). For some people, hepatitis B infection becomes chronic, meaning it lasts more than six months. Having chronic hepatitis B increases the risk of developing liver failure, liver cancer or cirrhosis — a condition that permanently scars the liver. Hepatitis B is a major global health problem. The burden of infection is highest in the WHO Western Pacific Region and the WHO African Region, where 116 million and 81 million people, respectively, are chronically infected. Sixty million people are infected in the WHO Eastern Mediterranean Region, 18 million in the WHO South-East Asia Region, 14 million in the WHO European Region and 5 million in the WHO Region of the Americas. The symptoms of HBV infection include jaundice, dark urine, fatigue, nausea, vomiting and abdominal pain. HBV has 10 genotypes termed A-J of which A-H (only 8) are found to infect humans. HBV genotypes are involved in different transmission rates: genotypes B and C are more frequent in Asia while genotypes A, D, and E are more frequent in sub-Saharan Africa.
The HBV PCR assay can detect the Hepatitis B virus and is a much more sensitive and fast detection method over conventional antibody-based and histopathological methods for the detection of viral infection or for describing the natural history of viral infection. The DiAGSure® Hepatitis B Viral Load Kit is an in vitro diagnostic (IVD) real-time polymerase chain reaction (qPCR) test involving TaqMan chemistry intended for the detection of viral DNA in human clinical and viral culture samples. The kit can detect HBV genotypes A-H. This two-plex PCR detects the precore/core protein gene of the viral genome and includes an RNase-P internal control (IC) reference gene in a single-tube reaction.
Color Coding (Caps) | Contents | Description | GDQ2039- 20R | GDQ2039- 50R | GDQ2039- 100R |
Red | WRTaqMan Master Mix | Amplification Mix | 350 µL | 800 µL | 1.4 mL |
Amber | Primer-Probe Mix | Amplification Reagent | 50 µL | 120 µL | 250 µL |
Yellow | HBV Standard 1 | Quantification Standard | 50 µL | 100 µL | 200 µL |
Yellow | HBV Standard 2 | Quantification Standard | 50 µL | 100 µL | 200 µL |
Yellow | HBV Standard 3 | Quantification Standard | 50 µL | 100 µL | 200 µL |
Yellow | HBV Standard 4 | Quantification Standard | 50 µL | 100 µL | 200 µL |
Blue | Negative Control (NC) | Negative Control | 200 µL | 500 µL | 1 mL |
White | DNA Dilution Buffer | Tris-based buffer | 200 µL | 500 µL | 1 mL |
There are four quantification standards provided with the kit with viral DNA copies as follows:
Standard | IU/μL |
HBV Standard 1 | 104 |
HBV Standard 2 | 103 |
HBV Standard 3 | 102 |
HBV Standard 4 | 101 |
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 4th WHO International Standard for HBV DNA for NAT (NIBSC Code: 10/266). 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 HBV DNA copies/mL and HBV International Units/mL (IU/mL) is 5.6 copies/IU.
20 Reaction
₹ POR
50 Reaction
₹ POR
100 Reaction
₹ POR
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