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GeneProof Cytomegalovirus (CMV) PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to 1st WHO International Standard NIBSC 09/162

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

CONTAMINATION PREVENTION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible carryover contamination

 

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/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_CMV_Instand_03_22_EN
pdf, [1.06 MB]
; GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 kB]
; GP_CMV_QCMD_10_21_EN
pdf, [237.23 kB]
; GP_CMV_Instand_03_21_EN
pdf, [1.02 MB]
Choose all

Technical specification

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
AMPLilab Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 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 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

*NOTE: Validated only on manual extraction GeneProof PathogenFree DNA Isolation Kit.

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.6 MB]
; GP_CMV_ Mode d´emploi_FR
pdf, [267.92 kB]
; GP_CMV_Advisory Notice_EN_CZ
pdf, [266.81 kB]
; GP_CMV_Advisory_Notice_05_22_EN
pdf, [566.08 kB]
; GP_CMV_Instruction for Use_EN
pdf, [235.12 kB]
; GP_CMV_Instruction_for_Use_IT
pdf, [76.92 kB]
; GP_CMV_Manual de Uso_ES
pdf, [220.07 kB]

Declaration of Conformity

; GP_CMV_Declaration_of_Conformity_EN
pdf, [581.06 kB]
; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]

MSDS

; GP_CMV_Safety_Data_Sheet_EN
pdf, [278.57 kB]

PCR Template

; GP_CMV_Mic
micassay, [13.83 kB]
; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_CMV_Leaflet_EN
pdf, [158.34 kB]
; GP_IT_Panel_Leaflet_EN
pdf, [275.02 kB]
; GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 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]
; LightCycler 2.0_EN
pdf, [1.8 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, [1.81 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]
Files are available only for registered users.