GeneProof Adenovirus PCR Kit

CE IVD

 

PRODUCT DETAIL

The PCR kit is designed for Adenovirus detection by the real-time Polymerase Chain Reaction (PCR) method.

The Adenovirus detection consists in amplification of highly conservative DNA sequence of E2B gene and in measurement of fluorescence increase. The Adenovirus presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR by amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

 

TECHNICAL SPECIFICATION 

Technology real-time PCR
Type of analysis qualitative and quantitative
Target Sequence highly conservative DNA sequence of E2B gene
Analytical Specificity

Adenovirus, 100 %

Analytical Sensitivity (LoD)

reaches up to 81.41 cp/ml with the probability of 95 % (on AcroMetrixTM Adenovirus Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)
reaches up to 2371.645 cp/ml with the probability of 95 % (on Qnostics ADV Molecular 'Q' Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range

1010 – 102.5 cp/ml (using AcroMetrixTM Adenovirus Plasma Panel)
1010 – 5x103 cp/ml (using Qnostics ADV Molecular 'Q' Panel)

Reporting Units cp/μl
Metrological Traceability

Qnostics ADV Molecular 'Q' Panel

Extraction / Inhibition Control

PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen aspirate, plasma, stool*, swab, urine, whole blood
*only in combination with QIAamp DNA stool Mini Kit
Storage -20 ± 5 °C
Validated Extraction Method

croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
QIAamp DNA Stool Mini Kit

Instruments

croBEE Real-Time PCR System*
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels – results at www.geneproof.com
Regulatory status CE IVD

* Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Adenovirus PCR Kit ADV/ISIN/025 real-time PCR 25 reaction
GeneProof Adenovirus PCR Kit ADV/ISIN/050 real-time PCR 50 reaction
GeneProof Adenovirus PCR Kit ADV/ISIN/100 real-time PCR 100 reaction
GeneProof Adenovirus PCR Kit ADV/ISEX/025 real-time PCR 25 reaction
GeneProof Adenovirus PCR Kit ADV/ISEX/050 real-time PCR 50 reaction
GeneProof Adenovirus PCR Kit ADV/ISEX/100 real-time PCR 100 reaction