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GeneProof Team
Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
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
Product name | Catalog no. | Technology | Packaging |
GeneProof Cytomegalovirus (CMV) PCR Kit | CMV/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Cytomegalovirus (CMV) PCR Kit | CMV/ISEX/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Regulatory Status | CE1023IVD |
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 with the probability of 95 %) |
122.594 IU/ml (on CMV NIBSC 09/162, manual extraction GeneProof PathogenFree DNA Isolation Kit) 165.237 IU/ml (on CMV NIBSC 09/162, automatic extraction croBEE 201A Nucleic Acid Extraction Kit) |
Diagnostic Specificity | 90.67% (CI95%: 81.15% – 95.85%) |
Diagnostic Sensitivity | 92.86% (CI95%: 64.17% – 99.63%) |
Linear Range | 1010 - 102.5 IU/ml with precision of ± 0.5 log |
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 Kit) |
Reporting Units | U/ml |
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, urine*, whole blood |
Storage |
-20 ± 5 °C |
Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
Instruments |
croBEE 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 |
*NOTE: Validated only on manual extraction GeneProof PathogenFree DNA Isolation Kit.
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