GeneProof SARS-CoV-2 Screening PCR Kit - NEW PRODUCT

CE IVD

ISO 13485

 

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
  • 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%, 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
reaches up to 259.72 cp/ml* using COVID TOUCH PCR program on Qnostics SARS-CoV-2 Medium Q Control with automatic extraction croBEE NA16 Nucleic Acid Extraction System
reaches up 25.93 cp/μl* using COVID TOUCH PCR program (material quantified on standard 1; SARS CoV (Frankfurt 2003, EVAg,. Corman))
reaches up to 200 cp/ml using COVID TOUCH PCR with direct detection
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
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 Plus
LightCycler® 480
Mic qPCR Cycler
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
 Required Detection Channels FAM, HEX
 External Quality Assessment tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com
Regulatory Status

CE IVD

 

 

  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

 

 

 

 

 

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof SARS-CoV-2 Screening PCR Kit - NEW PRODUCT COV2S/GP/100 real-time PCR 100 reakcí