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GeneProof Parvovirus B19 PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to WHO International Standard NIBSC 12/208
  • Enables reliable viral load monitoring

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one run

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

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating 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 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_B19_QCMD_04_22_EN_02
pdf, [199.36 kB]
; GP_B19_QCMD_04_22_EN_01
pdf, [199.44 kB]
; GP_B19_Instand_03_22_EN
pdf, [1.06 MB]
; 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]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
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
GeneProof PathogenFree DNA Isolation Kit 90,29 IU/ml
croBEE 201A Nucleic Acid Extraction Kit 156,7 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 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, [1.61 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]
; GP_B19_Instruction_for_Use_ES
pdf, [371.56 kB]
; GP_B19_Instruction_for_Use_FR
pdf, [323.57 kB]

Declaration of Conformity

; GP_B19_Declaration_of_Conformity_EN
pdf, [605.74 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, [139.95 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 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.