EBV Real Time PCR Kit 1.0

Epstein-Barr Virus (EBV) is a member of the herpesvirus family and is one of the most common human viruses. The virus occurs worldwide, and most people become infected with EBV sometime during their lives. Infants become susceptible to EBV as soon as maternal antibody protection (present at birth) disappears. Many children become infected with EBV, and these infections usually cause no symptoms or are indistinguishable from the other mild, brief illnesses of childhood. In developed countries, many persons are not infected with EBV in their childhood years. When infection with EBV occurs during adolescence or young adulthood, it causes infectious mononucleosis 35% to 50% of the time. Symptoms of infectious mononucleosis are fever, sore throat, and swollen lymph glands. Sometimes, a swollen spleen or liver involvement may develop. Heart problems or involvement of the central nervous system occurs only rarely, and infectious mononucleosis is almost never fatal. Although the symptoms of infectious mononucleosis usually resolve in 1 or 2 months, EBV remains dormant or latent in a few cells in the throat and blood for the rest of the person’s life. Periodically, the virus can reactivate and is commonly found in the saliva of infected persons. This reactivation usually occurs without symptoms of illness. EBV also establishes a lifelong dormant infection in some cells of the body’s immune system. A late event in a very few carriers of this virus is the emergence of Burkitt’s lymphoma and nasopharyngeal carcinoma. EBV appears to play an important role in these malignancies, but is probably not the sole cause of disease

ViroGene EBV 1.0 Real-Time PCR Kit is based on the real-time PCR principle. The pathogen is detected using fluorescent dyes that are incorporated into oligonucleotide probes. The assay utilizes the 5’ exonuclease activity of Taq Polymerase to cleave a dual-labeled fluorescent hydrolysis probe during the extension phase of PCR

• Dual Probe Assay
  The highly mutable nature of pathogens often proves challenging in molecular assay design. Traditional qPCR assays are designed so that a single primer and probe set targets one location within the pathogen genome. However, these single-target assays often prove inadequate to detect and quantify viral targets. Sequence polymorphisms in the assay target region can cause impaired primer or probe binding, which may result in significant under-quantification or a false negative result. To eliminate this possibility, the ViroGene EBV qPCR assay targets two regions within the pathogen genome, utilizing unique primer and probe sets for each target site. The driving principle behind our multiple-target assay design is that when a polymorphism occurs in one assay target, the additional sets of primers and probes for the alternate target region will still detect and accurately quantify the pathogen and thus reduces the likelihood of under-quantification or a false negative result.

• All kit Components are Liquid Ready to use with enhanced freeze thaw stability (> 30 times)
• Using the highest standards for choice of enzymes on our kits which can tolerates all types of inhibitors found usually in clinical samples with no effect on result quality 

• Common Internal control a wide variety of Assays.    
• Common Reagents and common protocols which ensures running more than one test type on the same run

• Kit components enough to perform 110 Tests, to perform calibration and QC at no Extra cost

Item Name	EBV
Technology	Real-Time PCR
Type of Analysis	qualitative and quantitative
Target Sequence	DNA sequence of the single copy gene encoding the nuclear antigen 1 (EBNA1)
Specificity	Epstein-Barr virus, 100 %
Sensitivity (LoD)	reaches up to 150.0 IU/ml with the probability of 95 % (on NIBSC EBV 09/260) reaches up to 75 IU/ml with the probability of 95 % (on NIBSC EBV 09/260 using automatic extraction MagCore NA16 Nucleic Acid Extraction System)
Linear Range	1010 – 20 copy/ml with precision of ± 0.5 log
Reporting Units	copy/µl
Conversion Factor	1 IU = 1 cp
Metrological Traceability	NIBSC EBV 09/260
Extraction/Inhibition Control	Exogenous Internal Control
Validated Specimen *	plasma, serum
Storage	-20 ± 5 °C
Validated Extraction Method	ViroGene Viral RNA/DNA Extraction Kit & MagCore NA Extractor
Validated Instruments *	Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System DTlite Real-Time PCR System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus QuantStudio™ 3 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System
Required Detection Channels	FAM, HEX
Certification	CE IVD