ViroGene CMV PCR Kit 1.0

• 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 HCV, HBV, HIV-1 and HIV-2,CMV, HSV-1, HSV,2 to ensure ease of use with limited samples resources.

• 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.

• The Quantification Standards and Internal Control are stable at 2 – 8 C for up to 6 months with no effect on their stability and performance, to help you with fast reaction setup and minimum components for thawing.

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
Quantitative Kit	25 Tests	24563	50 Tests	24573	100 Tests	24583