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GeneProof Cytomegalovirus (CMV) PCR Kit

CE 1023 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 StandardNIBSC 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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

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/050 real-time PCR 50 reactions
GeneProof Cytomegalovirus (CMV) PCR Kit CMV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_CMV_QCMD_2019_EN
pdf, [221.38 kB]
GP_CMV_QCMD_C1.2018_EN
pdf, [220.37 kB]
GP_CMV_QCMD_C3.2018_EN
pdf, [217.65 kB]
GP_Instand_03.2018_EN
pdf, [1.21 MB]
GP_Instand_03.2019_EN
pdf, [326.84 kB]
Choose all

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 
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
Certification CE1023 IVD

*Validated instruments

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_CMV_Advisory Notice_EN_CZ
pdf, [266.81 kB]
GP_CMV_Instruction for Use_EN
pdf, [109.06 kB]
GP_CMV_Instruction for Use_ES
pdf, [95.91 kB]

Declaration of Conformity

GP_CMV_Declaration of Conformity_EN
pdf, [321.94 kB]
GP_FQAS EC Certificate_EN
pdf, [48.26 kB]

MSDS

GP_CMV_Safety Data Sheet_EN
pdf, [718.9 kB]

Manual

AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 2.0_EN
pdf, [1.94 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_EN
pdf, [2.33 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]

Product Leaflet

GP_CMV_Leaflet_EN
pdf, [161.91 kB]

PCR Template

GP_CMV_Mic_1
micassay, [13.83 kB]
Files are available only for registered users.