GeneProof Cytomegalovirus (CMV) PCR Kit
Kat.: CMV/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Cytomegalovírus minden genotípusának, beleértve a GB1-GB4 genotípusok, detektálására alkalmas ‘Ready-to-Use ‘ master mix. Az 4 IE antigént kódoló gén specifikus, egyetlen kópiájú, konzervatív DNS szekvenciát célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
DETECTION OF ALL CMV GENOTYPES
- The kit detects all genotypes of Cytomegalovirus including genotypes GB1-GB4
FULL TRACEABILITY WITH WHO STANDARDS
- Sensitivity was established with WHO certified strain (1st WHO International StandardNIBSC 09/162)
- Precise and fully traceable quantification according to NIBSC 09/162
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
EXCELLENT EQA PANEL RESULTS
- Very high diagnostic sensitivity (up to 99.5 % on core samples) and specificity (100 %) confirmed by analysis of QCMD panel reports from 2008 to present
UNIVERSAL PCR PROFILE
- Easily combinable with other PCR kits from the Immunocompromised / Transplanted group
- Simplifies laboratory workflow
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 | specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen |
| Analytical Specificity | Human Cytomegalovirus (CMV), 100 % |
| Analytical Sensitivity (LoD) | reaches up to 122.594 IU/ml with the probability of 95 % (on CMV NIBSC 09/162 using manual extraction GeneProof PathogenFree DNA Isolation Kit) reaches up to 165.237 IU/ml with the probability of 95 % (on CMV NIBSC 09/162 using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
| Diagnostic Specificity | 90.67% (CI95%: 81.15% – 95.85%) |
| Diagnostic Sensitivity | 92.86% (CI95%: 64.17% – 99.63%) |
| Linear Range | 1010 – 102.5 cp/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation Kit or automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
| Dynamic Range | 1010 – 122.594 cp/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 1010 – 165.237 cp/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
| Reporting Units | cp/µl |
| Conversion factor | 1 IU = 1 cp |
| Metrological Traceability | CMV NIBSC 09/162 |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | plasma, serum, whole blood, urine* |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation 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® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 3 / 5 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System Montania 4896 Real-Time PCR termocykler 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 | CE1023 IVD |
*validated only on manual extraction GeneProof PathogenFree DNA Isolation Kit
