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GeneProof SARS-CoV-2 South African/UK/BR Typing PCR Kit

CE IVD

PRODUCT ADVANTAGES
 

UNIQUE TYPING OF SARS-COV-2 VARIANTS

  • Fast typing of South African (B.1.351), British (B.1.1.7) and Brazil (P.1) variant
  • Intended for simultaneous SARS-CoV-2 positivity confirmation and variant typing 
  • Substitutes time-consuming sequencing


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 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 South African/UK/BR Typing PCR Kit COV2TYP2/GP/100 real-time PCR 100 reactions
GeneProof SARS-CoV-2 South African/UK/BR Typing PCR Kit COV2TYP2/GP/025 real-time PCR 25 reactions

EQA Panels

EQA results

GP_COV2TYP2_QCMD_07_21_EN
pdf, [234.48 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Intended User For professional use in laboratories with trained staff
Technology real-time PCR
Type of analysis qualitative
Target Sequence RdRp gene, S gene (UK/del 69-70, South African/D80A, Brazil/P26S)
Analytical Specificity SARS-CoV-2, 100 %, UK (B.1.1.7 variant), South African (B.1.351 variant), Brazil (P.1 variant)
Analytical Sensitivity
(LoD with 95% probability)

 159.65 cp/mL FAM channel on Qnostics SARS-CoV-2 Q Control (GeneProof PathogenFree RNA Isolation Kit)

Validated Specimen swab, transport medium: Bi-CoVTM set, eSWAB, PBS, physiological saline solution and UTM
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree RNA Isolation Kit
Instruments

croBEE Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System 
AriaMx Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 Plus

Required Detection Channels FAM, HEX, Cy5, Texas Red
Regulatory Status

CE IVD 

 

Nucleic Acid Purification

 

Medium

GeneProof PathogenFree RNA Isolation Kit

croBEE 201A Nucleic Acid Extraction Kit

ESwab

YES

YES

UTM

YES

YES

PBS

YES

YES

Physiological Saline Solution YES YES
Bi-CoVTM set YES YES

 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.49 MB]
GP_COV2TYP2_Instruction_for_use_EN
pdf, [203.18 kB]

Declaration of Conformity

GP_COV2TYP2_Declaration_of_conformity_EN
pdf, [626.81 kB]

Product Leaflet

GP_COVID-19_Solution_leaflet_EN
pdf, [279.35 kB]
GP_Leaflet_COV2TYP2_EN
pdf, [246.69 kB]
Files are available only for registered users.