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GeneProof Flu Multiplex PCR Kit

CE IVD New product
GeneProof Flu Multiplex PCR Kit

PRODUCT ADVANTAGES

 

MORE INFORMATION WITH LESS SAMPLES

  • Detects and distinguishes Influenza A, Influenza B and RSV in a single reaction tube
  • Suitable for differential diagnostics of infectious agents causing Flu and Flu-like symptoms

WHO RECOMMENDED DESIGN

  • Dual target detection of Influenza A (NP gene/M gene) and Influenza B

SINGLE TUBE READY-TO-USE MASTER MIX

  • Contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

HIGH SPECIFICITY

  • Detects all currently known Influenza A serotypes including H1N1, H1N1pdm09, H3N2, H5N8 and H7N
  • Detects both Influenza B lineages Victoria and Yamagata
  • Detects RSV A and RSV B

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 Flu Multiplex PCR Kit FLU/GP/025 real-time PCR 25 reactions
GeneProof Flu Multiplex PCR Kit FLU/GP/050 real-time PCR 50 reactions
GeneProof Flu Multiplex PCR Kit FLU/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_FLU_Instand_06.2019_EN
pdf, [338.1 kB]
open
GP_Instand_03.2019_EN
pdf, [326.84 kB]
open
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target sequence specific region in M gene and NP gene for Influenza A virus
two specific regions in HA gene for Influenza B virus
specific region in M gene for Respiratory syncytial virus A and B
Analytical Specificity Influenza A virus, Influenza B virus and Respiratory syncytial virus A and B, 100 %
Analytical Sensitivity (LoD)

reaches up to 25.75 cp/ml with the probability of 95 % for Influenza A virus (on INFA Medium Q Control,
Qnostics, using manual extraction GeneProof PathogenFree RNA Isolation Kit)
reaches up to 161.64 cp/ml with the probability of 95 % for Influenza A virus (on INFA Medium Q Control,
Qnostics, using automatic extraction croBEE NA16 Nucleic Acid Extraction System)
reaches up to 7.25 cp/μl with the probability of 95 % for Influenza B virus (on Amplirun® Influenza B RNA
control, Vircell)
reaches up to 43.57 cp/μl with the probability of 95 % for Respiratory syncytial virus (on Amplirun® RSV A RNA
control, Vircell)
Diagnostic Specificity 100.00% (CI95%: 79.95%–100.00%)
Diagnostic Sensitivity 92.31% (CI95%: 80.60%–97.51%)
Extraction/Inhibition Control

PCR inhibition and RNA extraction efficiency control 
Validated Specimen aspirate, BAL, swab, transport medium: Sigma MM*, Sigma Virocult*
Storage -20 ± 5 °C
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit
NucleoSpin® RNA Stool
Instruments

ccroBEE Real-Time PCR System**
Applied Biosystems 7500 Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 Plus
Required Detection Channels FAM, HEX, Cy5, Texas Red
External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
Certification CE IVD 

* Only in combination with GeneProof PathogenFree RNA Isolation Kit
** Validated instrument

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_FLU_Instruction for Use_CZ
pdf, [117.48 kB]
GP_FLU_Instruction for Use_EN
pdf, [78.37 kB]

Declaration of Conformity

GP_FLU_Declaration of Conformity_CZ
pdf, [292.53 kB]
GP_FLU_Declaration of Conformity_EN
pdf, [305.54 kB]

MSDS

GP_Safety Data Sheet_CZ
pdf, [134.4 kB]
GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]

Product Leaflet

GP_FLU_Leaflet_EN
pdf, [90.18 kB]
Files are available only for registered users.

Order

+420 543 211 679
sales@geneproof.com

Technical Support 

Contact form 
+420 730 176 222
support@geneproof.com

FAQ

 

 

News

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Gregor Johann Mendel - Father of Genetics. 

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