CMV Real Time PCR Kit

Cytomegalo Virus, a member of the Herpesviridae, is an enveloped virus with a double-stranded linear DNA genome. Infection is common and usually asymptomatic. The most severe form is congenital with severe generalized infection involving central nervous system and liver accompanied by lethargy, convulsions, jaundice, pneumonitis and encephalitis. For severely affected infants neonatal case fatality rate is high. Inapparent infections can be observed later in life, which are mononucleosis-like but without pharyngitis. Reactivation, infection, or reinfection may occur in immunocompromised patients (bone marrow and other transplants). Pneumonitis, hepatitis and retinitis are most common manifestations in this group. The distribution of the infection is worldwide. It is acquired early in developing countries. In developed areas serum antibodies is observed in 40% of adults, and in developing countries, the occurrence is 100%. The infection rate is higher in women. Immunodeficient patients (fetus, newborn, immunocompromised) are at higher risk. The mode of transmission is through intimate exposure by cutaneous or mucosal contact with infectious tissues, secretions or excretions (urine, saliva, breast milk, cervical secretions, semen). Infection of the fetus in the uterus and postnatal infection at delivery is possible. Blood transfusion is a common cause of post-transfusion mononucleosis (about 3% risk). The virus can also be transmitted through organ transplantation.

ViroGene CMV 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, ViroGene CMV RT-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 for 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	CMV
Technology	RT real-time PCR
Type of Analysis	qualitative and quantitative
Target Sequence	specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen
Specificity	Human Cytomegalovirus (CMV), 100 %
Sensitivity (LoD)	reaches up to 100.5 IU/ml with the probability of 95 % (on CMV NIBSC 09/162) reaches up to 65.237 IU/ml with the probability of 95 % (on CMV NIBSC 09/162 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	CMV NIBSC 09/162
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