GeneProof Cytomegalovirus (CMV) PCR Kit
CE1023 IVD
PRODUCT DETAIL
The PCR kit is designed for detection of human Cytomegalovirus by the real-time Polymerase Chain Reaction (PCR) method.
The CMV detection consists in amplification of a specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen and in measurement of fluorescence increase. The CMV 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 nonspecific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with 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 | 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 control (ISIN version) PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | plasma, serum, whole blood, urine* *validated only on manual extraction GeneProof PathogenFree DNA Isolation Kit |
| 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 StepOne™ / StepOnePlus™ Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| Quality control | quality management system is certified in compliance with the requirements of the standard ISO 13485 |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment Panels -results at www.geneproof.com |
| Regulatory Status | CE1023 IVD for in vitro Diagnostic Use |
*Validate instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Cytomegalovirus (CMV) PCR Kit | CMV/ISIN/025 | real-time PCR | 25 reactions |
| GeneProof Cytomegalovirus (CMV) PCR Kit | CMV/ISIN/050 | real-time PCR | 50 reactions |
| GeneProof Cytomegalovirus (CMV) PCR Kit | CMV/ISIN/100 | real-time PCR | 100 reactions |
| GeneProof Cytomegalovirus (CMV) PCR Kit | CMV/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Cytomegalovirus (CMV) PCR Kit | CMV/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof Cytomegalovirus (CMV) PCR Kit | CMV/ISEX/100 | real-time PCR | 100 reactions |