Epstein-Barr Virus (CE)
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- Rapid detection of all clinically relevant subtypes
- High priming efficiency
- Accurate controls to confirm extraction, and assay validity
- Lyophilised components for ambient shipping
- Highly specific detection profile
The genesig Real-Time PCR Epstein-Barr Virus Kit (CE) is CE-IVD marked and intended for in vitro diagnostic use in Europe.
Available for direct shipping to United Kingdom
ABOUT THIS PRODUCT
The genesig Real-Time PCR EBV Kit (CE) is intended to be used on the Applied Biosystems 7500 Real-Time PCR System, Bio-Rad CFX Real-Time PCR Detection System, and Roche LightCycler 480 Instrument II, to achieve quantitative detection of EBV DNA extracted from whole blood and blood plasma from immunocompromised patients in association with the designated extraction instrument and kits:
- Automated extraction - Roche MagNA Pure 24 and Roche MagNA Pure 24 Total NA Isolation Kit
- Manual extraction - QIAGEN QIAamp® DNA Mini Kit
Quantification Standards in the kits are calibrated against the First World Health Organization International Standards for Virus Nucleic Acid Amplification Techniques (NIBSC code 14/212), and demonstrate the kit has strong levels of sensitivity and specificity performance, as well as allowing harmonisation of results across labs.
Background to EBV
The EBV infection is very common and in most of cases is asymptomatic; however, if symptomatic it commonly presents itself with mononucleosis (glandular fever). Due to the ease of spreading EBV infection through bodily fluids, around 90% of people contract EBV infection at some point in their lives.The virus will remain latent and the hosts immune system should be able to keep the virus persistently latent.
For immunocompromised patients including post-transplantation individuals, the virus can cause serious damage while the patient is in their vulnerable state. Its known to cause and be associated with malignant lymphoproliferation, specifically B-Cell lymphoproliferative disorder or ‘post-transplant lymphoproliferative disease’ (PTLD). Primary EBV infection is a major risk factor for development of these tumors, however, PTLD can occur via reactivated virus. Infections for immunosuppressed patients can be a cause organ transplant rejection.Therefore, monitoring of viral load alongside medication regimes is of the upmost importance for patients’ health and well-being.
The genesig Real-Time PCR EBV Kit (CE) is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of Epstein-Barr virus (EBV) DNA. The probe system is based on standard hydrolysis probe system known as TaqMan® Technology. The EBV specific probe will be labelled with the FAM fluorophore and the internal control will be labelled with VIC fluorophore.
The assay includes an Internal Control to identify possible PCR inhibition, to measure extraction purity and to confirm the integrity of PCR run.
Quantification Standards (QS) are included that contain standardised concentrations of EBV specific DNA. These Quantification Standards were calibrated against the 1st World Health Organisation International Standard for Epstein-Barr virus for Nucleic Acid Amplification Techniques (NAT) (NIBSC code 14/212).The Quantification Standards can be used as positive controls, or to generate a standard curve, which can be used to determine the concentration of EBV specific DNA in a sample.
The analytical sensitivity was defined as the lowest concentration of analyte that could be reliably detected with 95% confidence. This was assessed across 3 clinical specimens over 3 days producing at least 30 replicates for each sample type plus extraction system combination:
- The analytical sensitivity for plasma samples extracted with the MagNA Pure 24 Total NA Isolation Kit was found to be 337.5 IU/ml.
- The analytical sensitivity for blood samples extracted with the MagNA Pure 24 Total NA Isolation Kit was found to be 168.8 IU/ml.
- The analytical sensitivity for plasma samples extracted with the QIAamp DNA Mini Kit was found to be 213.13 IU/ml.
- The analytical sensitivity for blood samples extracted with the QIAamp DNA Mini Kit was found to be 426.25 IU/ml.