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The GeneProof Adenovirus PCR Kit is a highly reliable and accurate solution for detecting all human adenovirus species, including respiratory species A-D, G, and gastrointestinal species E-F. Its clinical performance was provided by The National Institute of Public Health, and it is compatible with a wide range of validated clinical materials, including aspirate, plasma, stool, swab, urine, and whole blood. The Ready-to-Use Master Mix eliminates contamination, and it is CE IVD certified, making it a versatile solution that is compatible with a wide range of real-time PCR devices. With the GeneProof Adenovirus PCR Kit, you can detect adenovirus with ease and confidence, ensuring timely and accurate diagnoses.
Instructions for Use
Declaration of Conformity
MSDS
Publications
Manual
PCR Templates
Introducing the GeneProof Adenovirus PCR Kit – the ultimate solution for your adenovirus detection needs. This kit is designed to detect all human adenovirus species, including respiratory species A-D, G and gastrointestinal species E-F, ensuring accurate results every time. What’s more, the clinical performance of this kit was provided by The National Institute of Public Health, giving you the assurance of a high-quality diagnostic tool.
The GeneProof Adenovirus PCR Kit is compatible with a wide range of validated clinical materials, including aspirate, plasma, stool, swab, urine, and whole blood, enabling the detection of both respiratory and gastrointestinal samples. The Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs, eliminating possible contamination with amplification products, ensuring accurate and reliable results.
This CE IVD certified diagnostic test is also compatible with a wide range of real-time PCR devices, making it a versatile and practical solution for your laboratory. With the GeneProof Adenovirus PCR Kit, you can detect adenovirus with ease and confidence, ensuring timely and accurate diagnoses.
| 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 AcroMetrixTMAdenovirus 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
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