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GeneProof SARS-CoV-2 Screening 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 IN TWO CHANNELS

  • Intended for two channel thermocyclers
  • 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 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 Screening PCR Kit COV2S/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_COV2S_QCMD_2020_EN
pdf, [201.27 kB]
GP_CoV2S_QCMD_August_2020_EN
pdf, [161.22 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target sequence RdRp gene, E gene and N gene
Analytical Specificity SARS-CoV-2, 100%, detection is based on the method recommended by WHO (Corman et al, 2020)
Analytical Sensitivity (LoD with 95% Probability)

reaches up to 66.19 cp/ml using COVID TOUCH PCR program on Qnostics SARS-CoV-2 Medium Q Control
with manual extraction GeneProof PathogenFree RNA Isolation Kit
reaches up to 51.75 cp/ml using COVID TOUCH PCR program on Qnostics SARS-CoV-2 Medium Q Control
with manual extraction GeneProof Universal Nucleic Acid Extraction Kit

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 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
Mic qPCR Cycler
LightCycler® 480
LineGene 9600 Plus
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessment tested by INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
Certification

CE IVD 

*Validated instruments

 

Nucleic Acid Purification

 

 

GeneProof PathogenFree RNA Isolation Kit

GeneProof Universal Nucleic Acid Extraction Kit

croBEE NA16 Nucleic Acid Extraction System

Direct detection

ESwab

YES

NO

NO

YES

UTM

YES

YES

YES

YES

eNAT

YES

YES

YES

NO

PBS

YES

YES

YES

YES

 

News

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_COV2S_Advisory_Notice_EN_CZ
pdf, [277.58 kB]
GP_COV2S_Instruction for Use_EN
pdf, [247.83 kB]

Declaration of Conformity

GP_COV2S_Declaration of Conformity_EN
pdf, [305.62 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_COV2S_Leaflet_EN
pdf, [678.1 kB]
GP_Covid19_GPack_Leaflet_ EN
pdf, [1.26 MB]

Others

GP_COV2S_Pasteur Institute Certificate
pdf, [364.11 kB]

PCR Template

GP_COV2S_ABI7500
edt, [10.31 kB]
GP_COV2S_croBEE
fqt, [4.93 kB]
GP_COV2S_mic
micassay, [19.14 kB]
GP_COV2_ABI7500
edt, [10.33 kB]
GP_COV2_CFX
prcl, [1.35 kB]
GP_COV2_LC480
ixo, [9.5 kB]
GP_COV2_RG
ret, [14.88 kB]
Files are available only for registered users.