It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.
GeneProof Team
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 | IU/ml |
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.
+420 543 211 679
[obfuscate_1_|114|88|104|97|112|63|94|97|106|98|111|105|107|107|99|45|90|107|105]
Send request
+420 730 176 222
[obfuscate_1_|114|108|108|108|108|113|107|60|99|98|109|92|108|110|108|110|93|42|95|108|108]
GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…