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GeneProof SARS-CoV-2 RdRp Confirmatory PCR Kit

CE IVD GP line New product

PRODUCT ADVANTAGES
 

AFFORDABLE SOLUTION FOR FAST SCREENING

  • Suitable for SARS-CoV-2 screening or confirmation
  • Simple and robust product composition
  • Direct detection possibility
  • Less than 1 hour PCR protocol
     

HIGH SPECIFICITY AND SENSITIVITY 

  • Excellent QCMD panel results
  • Proven SARS-CoV-2 specificity


EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional pipetting of PCR reagents necessary
  • Significantly simplifies laboratory workflow


CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carry-over contamination

MADE IN EU

  • Developed and manufactured in the Czech Republic, the member of the European Union

 

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 RdRp Confirmatory PCR Kit COV2C/GP/100 real-time PCR 100 reactions
GeneProof SARS-CoV-2 RdRp Confirmatory PCR Kit COV2C/GP/025 real-time PCR 25 reactions

EQA Panels

EQA results

GP_COV2C_croBEE_QCMD_ 2020_EN
pdf, [164.69 kB]
GP_COV2C_IRNA_QCMD_ 2020_EN
pdf, [164.65 kB]
GP_COV2C_QCMD_2020
pdf, [161.26 kB]
GP_COV2C_QCMD_4_2021_EN
pdf, [221.26 kB]
Choose all

Technical specification

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

reaches up 25.29 cp/ml on Qnostics SARS-CoV-2 Medium Q Control with GeneProof PathogenFree RNA Isolation Kit
reaches up 32.73 cp/ml on Qnostics SARS-CoV-2 Medium Q Control with GeneProof Universal Nucleic Acid Extraction Kit
reaches up 40.89 cp/ml on Qnostics SARS-CoV-2 Medium Q Control with croBEE 201A Nucleic Acid Extraction Kit
reaches up 96.28 cp/ml on Qnostics SARS-CoV-2 Medium Q Control with myCROBE® Fully Automated Instrument

Extraction/Inhibition Control

PCR inhibition and RNA extraction efficiency control 

Validated Specimen saliva**, swab, transport medium
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree RNA Isolation Kit
GeneProof Universal Nucleic Acid Extraction Kit
myCROBE® Fully Automated Instrument
Instruments

croBEE Real-Time PCR System
myCROBE® Fully Automated Instrument
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LightCycler 480
LineGene 9600 Plus
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

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

CE IVD 

** Validated only for croBEE 201A Nucleic Acid Extraction Kit and GeneProof PathogenFree RNA Isolation Kit

 

Nucleic Acid Purification

 

Medium

GeneProof PathogenFree RNA Isolation Kit

GeneProof Universal Nucleic Acid Extraction Kit

croBEE 201A Nucleic Acid Extraction Kit

Direct Detection 

ESwab

YES

NO

YES 

 - 

UTM

YES

YES

YES

 NO

eNAT

YES

YES

YES

 - 

PBS

YES

YES

YES

YES 

Bi-CoVTM set  -   -  YES* - see note below

* Direct detection (Bi-CoVTM set)
The direct detection procedure using the Bi-CoVTM set differs from the direct detection procedure using other media. Follow the instructions provided with the Bi-CoVTM set.

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.43 MB]
GP_CoV_2C_Instruction for use_ EN
pdf, [261.85 kB]

Declaration of Conformity

GP_COV2C_Declaration of Conformity_EN
pdf, [615.43 kB]

Product Leaflet

GP_COV2C_Product Leaflet_EN
pdf, [369.59 kB]

PCR Template

GP_FAST_2CH_3CH_AriaMx
amxt, [3.52 kB]
GP_FAST_2CH_3CH_CroBee
fqt, [4.91 kB]
GP_FAST_BioRad
prcl, [1.31 kB]
Files are available only for registered users.