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GeneProof SARS-CoV-2 PCR Kit

CE IVD New product

PRODUCT ADVANTAGES

 

UNIQUE SPECIFICITY AND SENSITIVITY

  • Excellent QCMD panel results
  • Specificity for only SARS-CoV-2 confirmed, doesn´t detect other common coronaviruses

TRIPLE TARGET DETECTION

  • Three independent targets in one tube
  • Avoids false negative results
  • Targets: RdRp gene, E gene, N gene (design recommended by WHO)


UNIQUE INTERNAL CONTROL CONSTRUCTION

  • Internal control imitates natural virus particle
  • Control of the whole diagnostic process including viral nucleoproteine lysis, RNA extraction, reverse transcription and PCR amplification
  • Enables full control of any non-isolation sample pretreatment

SINGLE TUBE READY-TO-USE MASTER MIX

  • Master Mix contains all components for PCR amplification
  • No additional pipetting of PCR reagents necessary
  • Significantly simplifies laboratory workflow
     

MADE IN CZECH REPUBLIC

  • Developed and manufactured in the Czech Republic, the member of the EU

 

Beneficial in Covid-19 • Flu • RSV GPack combination with GeneProof Flu Multiplex PCR Kit.

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof SARS-CoV-2 PCR Kit COV2/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_CoV2_QCMD _August_2020_EN
pdf, [161.22 kB]
GP_COV2_QCMD_2020_ EN
pdf, [201.23 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target sequence specific region in RdRp gene, E gene and N gene
Analytical Specificity SARS-CoV-2, 100 %
Analytical Sensitivity (LoD with 95% Probability)

reaches up to 75,49 cp/ml using COVID TOUCH PCR program on Qnostics SARS-CoV-2 Medium Q Control
with manual extraction GeneProof PathogenFree RNA Isolation Kit (channel FAM)
reaches up to 59,95 cp/ml using COVID TOUCH PCR program on Qnostics SARS-CoV-2 Medium Q Control
with manual extraction GeneProof Universal Nucleic Acid Extraction Kit (channel FAM)

Extraction/Inhibition Control

PCR inhibition and RNA extraction efficiency control 

Validated Specimen swab, transport medium
Storage -20 ± 5 °C
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit
GeneProof Universal Nucleic Acid Extraction Kit
Instruments

croBEE Real-Time PCR System*
Applied Biosystems 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
LightCycler® 2.0
LineGene 9600 Plus
Rotor-Gene 3000
Rotor-Gene Q
SLAN® Real-Time PCR System

Required Detection Channels FAM, HEX, Cy5
External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
Certification CE IVD 

*Validated instruments

News

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_COV2_Advisory_Notice_EN_CZ
pdf, [276.65 kB]
GP_COV2_Instruction for Use_EN
pdf, [254.32 kB]

Declaration of Conformity

GP_COV2_Declaration of Conformity_EN
pdf, [304.64 kB]

MSDS

GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

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

Product Leaflet

GP_COV2_Leaflet_EN
pdf, [684.02 kB]
GP_Covid19_GPack_Leaflet_ EN
pdf, [1.26 MB]

PCR Template

GP_COV2_ABI7500
edt, [10.33 kB]
GP_COV2_CFX
prcl, [1.35 kB]
GP_COV2_croBEE
fqt, [4.97 kB]
GP_COV2_LC480
ixo, [9.5 kB]
GP_COV2_RG
ret, [14.88 kB]
Files are available only for registered users.