ampliCube HEV 2.0 Quant
Real-time RT-PCR for detection and quantification of Hepatitis E virus (HEV) RNA in human plasma, serum or stool.
Hepatitis E virus is one of the most common viral causes of acute hepatitis worldwide. An infection can have an inapparent to fulminant clinical manifestation. The acute hepatitis E infection is comparable to that of a hepatitis A infection. It causes flu-like symptoms, nausea, vomiting / diarrhea, fever, joint and headaches and is associated by an increase in liver enzymes. A HEV infection is usually self-limiting.
There are four human pathogenic HEV genotypes (1–4) described that differ in their geographical distribution, transmission and possible complications.
The HEV genotypes 1 and 2 occur primarily in developing countries and the transmission is usually fecal-oral via contaminated drinking water. During pregnancy a high percentage of these HEV infections can have a fulminant progression with a high fatality rate (~20%). In industrial countries the HEV genotypes 3 and 4 are widespread and are usually transmitted by infected pork that has not been adequately cooked. Cases involving transmission by blood products or transplants have also been described. For this reason and due to the partly high seroprevalences described (up to 50%), some European countries have already included HEV in the universal blood donor screening using nucleic acid testing (NAT). Most cases in Europe are caused by HEV genotype 3 and are often asymptomatic. Immunosuppressed patients are a risk group in this regard because more than 50% of these patients develop chronic HEV disease and a rapid progression to liver cirrhosis is possible. Determination of the viral load using quantitative NAT-assays is necessary to monitor such patients and their therapy. Mainly in the context of HEV Genotype 3 infections, also extrahepatic manifestations have been described, such as neurological injuries like neuralgic amyotrophy (NA) or the Guillain-Barré syndrome (GBS).
The ampliCube HEV 2.0 Quant is a highly sensitive and flexible real-time RT-PCR test system for the detection of the four human pathogenic HEV genotypes in human plasma, serum or stool. The test can deliver qualitative and/or quantitative results and its performance is suitable for blood donor screening.
Product Advantages for Your Benefit
- High sensitivity (LoD: 36.13 IU/ml), suitable for single sample testing (ID-NAT) and sample pool testing (MP-NAT)
- Detection of all four human pathogenic genotypes occurring worldwide
- Qualitative and/or quantitative evaluation, determination of viral load (IU/ml) possible
- Validated for various types of sample material (human plasma, serum and stool)
- Easy to use: enzyme mix is coloured blue for visual control
- Complete: positive and negative control, internal control (extraction and inhibition control) as well as standards for quantification
- High flexibility: use of different extraction methods and real-time PCR cycler possible
- CE label: The ampliCube HEV 2.0 Quant test meets the high standards of the European Directive 98/79/EC on in vitro diagnostic medical devices
Evaluation
The ampliCube HEV 2.0 Quant has been fully validated with LightCycler Instrument 480 II (Roche). For extraction of nucleic acid the MagNAPure Compact (Roche) and the Total Nucleic Acid Kit I (Roche) were used.
(A compatibility list is available for additional extraction and detection methods.)
