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GeneProof Parvovirus B19 PCR Kit

GeneProof B19 testing

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/050 real-time PCR 50 reactions
GeneProof Parvovirus B19 PCR Kit B19/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_B19_QCMD_2019_EN
pdf, [186.38 kB]
GP_B19_QCMD_2020_EN
pdf, [190.66 kB]
GP_Instand_03.2019_EN
pdf, [303.02 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 VP1 protein (capsid protein)
Analytic Specificity

Parvovirus B19, 100 %

Analytic Sensitivity (LOD) reaches up to 90.29 IU/ml with the probability of 95 % (on Parvovirus B19 NIBSC 12/208 using manual
extraction GeneProof PathogenFree DNA Isolation Kit)
reaches up to 156.7 IU/ml with the probability of 95 % (on Parvovirus B19 NIBSC 12/208 using automatic
extraction croBEE NA16 Nucleic Acid Extraction System)
Linear Range  108 – 102.5 IU/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  108 – 90.29 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
108 – 156.7 IU/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction System)
Reporting Units IU/μl
Conversion Factor 1 IU = 1.6 cp
Metrological Tracebility  Parvovirus B19 NIBSC 12/208
Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control (ISEX version)
Validated Specimen plasma, whole blood
Storage -20 ± 5 °C
Validated Extraction Method 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
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LightCycler 480
LineGene 9600 Plus
Mic qPCR Cycler
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
Required Detection Channels FAM, HEX
Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment Regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com
Certification CE IVD 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_B19_Instruction for Use_EN
pdf, [90.41 kB]
GP_B19_Instruction for Use_ES
pdf, [77.18 kB]
GP_B19_Manual de Uso_SP
pdf, [77.18 kB]

Declaration of Conformity

GP_B19_Declaration of Conformity_EN
pdf, [266.02 kB]

MSDS

GP_Safety Data Sheet_EN
pdf, [148.84 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]

Product Leaflet

GP_B19_Leaflet_EN
pdf, [175.28 kB]

PCR Template

GP_Parvovirus_Mic_1
micassay, [22.29 kB]
Files are available only for registered users.