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GeneProof SARS-CoV-2 Advanced PCR Kit

CE IVD New product GP line

PRODUCT ADVANTAGES

 

W.H.O. RECOMMENDED DESIGN

  • Three targets (RdRp/E/N genes) in one reaction 
  • Confirmation in an independent channel (RdRp gene)
  • Triple protection against detection failures caused by virus mutations

ENDOGENOUS INTERNAL CONTROL

  • Human RNase P gene for the control of the whole diagnostic process including of proper sampling
  • Simplifies laboratory workflow

FASTER EXAMINATION

  • Direct detection possibility with unique sampling set Bi-CoVTM
  • Fast PCR profile – less than 1 hour

EASY-TO-USE CONCEPT

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

CONTAMINATION PREVENTION

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

MADE IN EUROPEAN UNION

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

 

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 Advanced PCR Kit COV2A/GP/100 real-time PCR 100 reactions
GeneProof SARS-CoV-2 Advanced PCR Kit COV2A/GP/025 real-time PCR 25 reactions

Technická specifikace

Technology real-time PCR
Type of analysis qualitative
Target Sequence RdRp, N and E genes
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)

GeneProof PathogenFree RNA Isolation Kit FAM 584.07 IU/mL Cy5 112.94 IU/mL  NIBSC 20/146 SARS-CoV-2

Inhibition/extraction Control PCR inhibition and RNA extraction efficiency control
Validated Specimen swab, transport medium: BiCoVTM, PBS, physiological saline solution, UTM (Copan)
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree RNA Isolation Kit
Instruments

croBEE Real-Time PCR System
AriaMx Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 Plus

External Quality Assessment

Tested in INSTAND e.V. External Quality Assessment Panel
Required Detection Channels FAM, HEX, Cy5
Regulatory Status

CE IVD 

 

Nucleic Acid Purification

 

Medium

GeneProof PathogenFree RNA Isolation Kit

croBEE 201A Nucleic Acid Extraction Kit

Direct detection

UTM (Copan)

YES

YES

PBS

YES

YES

Physiological Saline Solution YES YES
Bi-CoVTM set (Bioinova)  – YES

 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.49 MB]
GP_COV2A_ Instruction_for_use_EN
pdf, [233.11 kB]
GP_COV2A_Advisory_Notice_10_21_CZ_EN
pdf, [396.67 kB]

Declaration of Conformity

GP_COV2A_ Declaration of Conformity_EN
pdf, [618.14 kB]

MSDS

GP_SARS-CoV-2A_Safety Data Sheet_EN
pdf, [278.66 kB]

Product Leaflet

GP_COV2A_Leaflet_EN.pdf
pdf, [117.24 kB]
GP_COVID-19_Solution_leaflet_EN
pdf, [528.3 kB]
Files are available only for registered users.