Hepatitis B virus

Hepatitis B virus (HBV) is divided into four major serotypes (adr, adw, ayr, ayw) based on antigenic epitopes present on its envelope proteins and into eight genotypes (labeled A through H) according to overall nucleotide sequence variation of the genome. The genotypes have a distinct geographical distribution and are used in tracing the evolution and transmission of the virus. Differences between genotypes affect the disease severity, course and likelihood of complications and response to treatment and possibly vaccination. A possible new „I“ genotype has been described, but acceptance of this notation is not universal. Different genotypes may respond to treatment in different ways.

HBV is one of a few known non-retroviral viruses which use reverse transcription as a part of its replication process. Hepatitis B is an infectious illness that infects the liver and causes an inflammation called hepatitis. Transmission of HBV results from exposure to infectious blood or body fluids such as semen and vaginal fluids, while viral DNA has been detected in the saliva, tears and urine of chronic carriers with high titer DNA in serum. Perinatal infection is a major route of infection in endemic countries. Other risk factors for developing HBV infection includes working in a health care setting, transfusions and dialysis. Acute infection with HBV is associated with acute viral hepatitis - an illness that begins with general ill-health, loss of appetite, nausea, vomiting, body aches, mild fever, dark urine and then progresses to development of jaundice. It has been noted that itchy skin has been an indication of a possible symptom of all hepatitis virus types. The illness lasts for a few weeks and then gradually improves in most affected people. A few patients may have more severe liver disease (fulminant hepatic failure) and may die as a result. The infection may be entirely asymptomatic and may go unrecognized. Chronic infection with HBV may be either asymptomatic or may be associated with a chronic inflammation of the liver, leading to cirrhosis over a period of several years. This type of infection dramatically increases the incidence of hepatocellular carcinoma.

AmpliSens® HBV-FRT PCR kit is an amplification test for qualitative detection of HBV DNA in the clinical materials (blood plasma). The Internal Control is present in order to check all detection steps - DNA extraction and amplification. The analytical sensitivity depends on the DNA extraction kit as well as on the initial sample volume (50 IU/ml if the sample volume is 100 μl, 5 IU/ml if the sample volume is 1 ml).

AmpliSens® HBV-Monitor-FRT PCR kit is a test for quantitative detection of HBV DNA in clinical material (blood plasma). The linear measurement range of kit is 15–100.000.000 IU/ ml (1 ml sample), or 150–100.000.000 IU/ml (100 μl sample). In both kits, Internal Control amplification product is detected on the FAM/Green channel and HBV amplification product is detected on the JOE/Yellow/HEX channel.  HBV Genotype FRT PCR kit allows us to differentiate A, B, C and D genotypes of HBV.

Catalog   number	Description	Detection	Format	# of reactions	Certifi- cation	Assay detail	Shelf life	Fluorescent channels	Availa- bility
R-V5-Mod (RG,iQ,Mx,Dt)-CE	AmpliSens® HBV-FRT			112		qualitative	12  months
R-V5-MC (RG,iQ,Mx,Dt)-CE	AmpliSens® HBV-Monitor-FRT			80		quantitative	12  months
H-4021-1-14-CE	AmpliSens® HBV Monitor-L PCR kit variant FRT-L			480		quantitative	12 months
H-4022-1-14-CE	AmpliSens® HBV-Monitor-L PCR kit variant FRT-L			96		quantitative	12 months
NEW CE IVD H-1982-1-3-CE	AmpliSens® HBV-genotype-FRT PCR kit			55		genotyping	12 months

  Real-Time     Reverse transcription    Fluorescent End-Point     Reagents in stock tubes    Ready-to-use PCR tubes   
 on request     available