Welcome to GeneProof website!

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

 

User account
Forgot your password?
Searching

GeneProof Parvovirus B19 PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

HIGH SENSITIVITY AND TRACEABILITY

  • Sensitivity was established with certified strain (NIBSC 3rd WHO International standard 12/208)

PRECISE QUANTITATIVE DETECTION

  • Precise and fully traceable quantification according NIBSC 3rd WHO International standard 12/208

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Parvovirus B19 PCR Kit B19/ISEX 025 real-time PCR 25 reactions
GeneProof Parvovirus B19 PCR Kit B19/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 kB]
GP_B19_QCMD_08_21_EN_02
pdf, [196.33 kB]
GP_B19_QCMD_08_21_EN_01
pdf, [196.34 kB]
GP_B19_QCMD_05_21_EN_02
pdf, [194.46 kB]
GP_B19_QCMD_05_21_EN_01
pdf, [194.41 kB]
GP_B19_Instand_06_21_EN
pdf, [1 MB]
GP_B19_Instand_03_21_EN
pdf, [1.02 MB]
GP_B19_QCMD_2020_EN
pdf, [190.66 kB]
Choose all

Technical specification

Indication In vitro diagnostic medical device
Regulatory Status CE IVD / EC Directive 98/79/EC
Intended User For professional use in laboratories with trained staff
Test Principle Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection
Type of Analysis Qualitative and quantitative
Target Sequence

Gene encoding VP1 protein (capsid protein)

Analytical Specificity

Parvovirus B19, 100%

Analytical Sensitivity
(LoD with 95% probability)
Sample Processing Plasma Whole blood Performed on
GeneProof PathogenFree DNA Isolation Kit 90,29 IU/ml 95,96 IU/ml B19 NIBSC 12/208
croBEE 201A Nucleic Acid Extraction Kit 156,7 IU/ml 100,47 IU/ml
Diagnostic Specificity 100 % (CI95%: 90.40 % - 100 %)
Diagnostic Sensitivity 100 % (CI95%: 90.77 % - 100 %)
Positive Predictive Value 100 % (CI95%: 90.77 % - 100 %)
Negative Predictive Value 100 % (CI95%: 90.40 % - 100 %)
Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)
Reporting Units IU/ml
Conversion Factor IU = 1 cp
Metrological Traceability Parvovirus B19 NIBSC 12/208
Validated Specimen Plasma, whole blood (EDTA)
Storage Conditions (-20 ± 5 ) °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
Applied Instruments Instrument Name      
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    
Gentier 96E/96R Real-Time PCR System    
LightCycler® 480    
LineGene 9600 Plus    
Mic qPCR Cycler    
QuantStudioTM 3 / 5 Real-Time PCR System    
Rotor-Gene 3000 / 6000 / Q    
SLAN® Real-Time PCR System    
StepOneTM / StepOne PlusTM Real-Time PCR System    
Detection Channels FAM (B19), HEX/JOE/VIC (IS)
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.55 MB]
GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
pdf, [508.26 kB]
GP_B19_Advisory_Notice_EN
pdf, [1.38 MB]
GP_B19_Instruction for Use_EN
pdf, [334.07 kB]

Declaration of Conformity

GP_B19_Declaration of Conformity_EN
pdf, [266.02 kB]

MSDS

GP_B19_Safety_Data_Sheet_EN
pdf, [276.52 kB]

PCR Template

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]
GP_Parvovirus_Mic
micassay, [22.29 kB]
RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

GP_B19_Leaflet_EN
pdf, [175.28 kB]
GP_IT_Panel_Leaflet_EN
pdf, [275.02 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 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]
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.