GeneProof Adenovirus PCR Kit
Kat.: ADV/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A légúti A–D, G és az emésztő szervrendszeri E-F Adenovírus fajok detektálására alkalmas ‘Ready-to-Use ‘ master mix. Az E2B gén magasan konzervált DNS szekvenciáját célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
DETECTION OF ALL HUMAN ADENOVIRUS SPECIES
- The kit enables detection of Adenovirus respiratory species A–D, G and gastrointestinal species E-F
ASSURANCE BY NATIONAL REFERENCE LABORATORY
- Clinical performance was provided by The National Institute of Public Health (National Reference Laboratory for Influenza)
WIDE RANGE OF VALIDATED CLINICAL MATERIALS
- Validated specimen: aspirate, plasma, stool, swab, urine, whole blood
- Enables detection of both respiratory and gastrointestinal samples
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| Intended User | For professional use in laboratories with trained staff |
| 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 |
| Diagnostic Specificity | 87.98 % (CI95%: 82.16% – 92.15%) |
| Diagnostic Sensitivity | 100 % (CI95%: 91.11% – 100%) |
| Linear Range | 1010 – 102.5 cp/ml with precision ± 0.5 log (using AcroMetrix™ Adenovirus Plasma Panel) 1010 – 5×103 cp/ml with precision ± 0.5 log (using Qnostics ADV Molecular ‚Q‘ Panel) |
| Dynamic Range | 1010 – 81.41 cp/ml (using AcroMetrix™ Adenovirus Plasma Panel) 1010 – 2371.645 cp/ml (using Qnostics ADV Molecular ‘Q‘ Panel) |
| Reporting Units | cp/μl |
| Metrological Traceability | Qnostics ADV Molecular ‚Q‘ Panel |
| Extraction / Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | plasma, stool*, swab, urine, whole blood, aspirate * 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 |
| Certification | CE IVD |
* Validated instruments
