GeneProof Cytomegalovirus (CMV) PCR Kit

CE1023 IVD

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 Standard NIBSC 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

 

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 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
External Quality Assessment regularly tested by  QCMD and Instand e.V. External Quality Assessment Panels -results at www.geneproof.com
Regulatory Status CE1023 IVD

*Validate instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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