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 |
| 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 for in vitro Diagnostics Use |
* 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 |