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

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)
Analytical Specificity

Parvovirus B19, 100 % 

Analytical Sensitivity 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 Traceability Parvovirus B19 NIBSC 12/208
Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control (ISEX version)
Validated Specimen whole blood, plasma
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
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com
Regulatory Status CE IVD

* Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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