GeneProof SARS-CoV-2 PCR Kit

CE IVD

 

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
  • IC is included in the PCR kit

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

CONTAMINATION PREVENTION

• Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

MADE IN CZECH REPUBLIC

  • Developed and manufactured in the Czech Republic

 

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 65.44 cp/μl using UNI PCR program (material quantified on standard 1 (SARS CoV (Frankfurt 2003, EVAg,. Corman))
reaches up to 23.89 cp/μl using COVID SCREEN program (material quantified on standard 1 (SARS CoV
(Frankfurt 2003, EVAg,. Corman))
reaches up to 1.77 cp/μl using UNI PCR program on synthetic positive control
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
CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 Plus
SLAN® Real-Time PCR System
 Required Detection Channels FAM, HEX, Cy5
 External Quality Assessment tested by Instand e.V. External Quality Assessment Panels - results at www.geneproof.com
Regulatory Status

CE IVD

 

 

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof SARS-CoV-2 PCR Kit COV2/GP/100 real-time PCR 100 reactions