REALQUALITY RQ-EBV is an in vitro diagnostic (IVD) test kit for the detection and quantification of Epstein-Barr virus (EBV) DNA by Real-Time PCR.
Professional Note
Please read the instructions for use (IFU) carefully before performing the test. Contact a Viet Huy technical specialist for on-site validation support in your laboratory.
Epstein-Barr virus (EBV) is a Gammaherpesvirus with a linear, double-stranded DNA genome; it infects more than 90% of the world's population and is known as the causative agent of infectious mononucleosis (IM).
In a small proportion of immunocompromised individuals, an association has been reported between EBV infection and two types of malignant tumors: Burkitt lymphoma and undifferentiated nasopharyngeal carcinoma.
Moreover, recent studies show that EBV plays a role in the pathogenesis of various tumors in people with acquired or congenital immunodeficiency, such as people living with HIV and organ or bone marrow transplant recipients. These tumors mainly include B-cell lymphomas (both Hodgkin and non-Hodgkin), post-transplant lymphoproliferative disorder (PTLD) and T-cell lymphomas (e.g., nasal NK/T-cell lymphoma).
Detection and quantification of the viral genome provide a prognostic indicator for patients with EBV-related diseases, as the amount of viral DNA in peripheral blood, cerebrospinal fluid and biopsy samples correlates with the clinical outcome of the disease. In addition, studying viral presence in the blood (viremia) can be a useful tool for evaluating the efficacy of different treatments.
Contact the Viet Huy technical team for more information.
| Pre-mixed PCR master mix containing ROX reference dye for instrument normalization, and dUTP/UNG to prevent the risk of carryover contamination from previous amplifications | |
| Quality standards | CE-IVD, marketing authorization from the Ministry of Health (MOH), Class C, country of origin: G7 |
| Input samples | peripheral whole blood, plasma, serum, cerebrospinal fluid and lymphocyte pellets |
| Analytical sensitivity (Limit of Detection - LoD) | 3.65 viral genome copies/reaction |
| Linear range | 5 to 10^7 viral genome copies/reaction |
| Diagnostic specificity | 100% |
| Target gene | gene region of glycoprotein gp 350 |
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