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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