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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|
|Intended User||For professional use in laboratories with trained staff|
|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 %|
(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)
|Conversion factor||1 IU = 1 cp|
|Metrological Traceability||CMV NIBSC 09/162|
|Extraction/Inhibition Control||PCR inhibition and DNA extraction efficiency control|
plasma, serum, urine*, whole blood
-20 ± 5 °C
|Validated Extraction Methods||croBEE NA16 Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
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.
Association between acute, severe hepatitis in small children and Adenovirus infection is currently under…
GeneProof merges with American Laboratory Products Company.