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GeneProof SARS-CoV-2 Advanced PCR Kit

CE IVD New product

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

EQA Panels

EQA results

; GP_COV2A_QCMD_03_22_EN_02
pdf, [222.99 kB]
; GP_COV2A_QCMD_03_22_EN_01
pdf, [222.19 kB]
; GP_COV2A_QCMD_07_21_EN
pdf, [233.08 kB]
; GP_COV2A_QCMD_11_21_EN
pdf, [233.04 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD / EC Directive 98/79/EC
Intended User For professional use in laboratories with trained staff
Technology real-time PCR
Type of Analysis Qualitative
Target Sequence RdRp, N and E genes
Analytical Specificity SARS-CoV-2, 100 %

Analytical Sensitivity 
(LoD with 95% probability)

Sample Processing 

Channel Sensitivity Material
GeneProof PathogenFree RNA Isolation Kit (FAM)
FAM
Cy5
691.08 IU/ml
127.24 IU/ml
PBS
croBEE 201A Nucleic Acid Extraction Kit (FAM)
FAM
Cy5
1404.51 IU/ml
1654.57 IU/ml
PBS
croBEE®max Nucleic Acid Extraction Kit
FAM
Cy5
1127.56 IU/ml
1779.36 IU/m
PBS
Direct detection (Bi-CoV® ) (FAM) Cy5 5943.21 IU/ml Bi-CoV®
Diagnostic Specificity 100 % (CI95%: 99.16 % – 100 %)
Diagnostic Sensitivity 100 % (CI95%: 97.10 % – 100 %)
Positive Predictive Value 100 % (CI95%: 97.10 % – 100 %)
Negative Predictive Value 100 % (CI95%: 99.16 % – 100 %)
Reporting Units IU/ml
Metrological Traceability 1st WHO International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146)
Inhibition / Extraction Control Proper sampling, RNA extraction efficiency, reverse transcription and PCR inhibition control by endogenous Internal control (RNase P gene)
Validated Specimen Swab in transport medium (PBS, physiological saline solution, UTM) or in Bi-CoV® or in nuclease-free water (NFW)
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
croBEE®max Nucleic Acid Extraction Kit
GeneProof PathogenFree RNA Isolation Kit
Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
AriaMX Real-Time PCR System
BioQuant-96, Fluorescent Quantitative Detection PCR system
CFX96™/ Dx Real-Time PCR Detection system
Gentier 96E/96R Real-time PCR system
LightCycler® 480
LineGene 9600 Plus
Mic qPCR Cycler
QuantStudioTM 5 Real-time PCR system
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

External Quality Assessment

Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com
Required Detection Channels FAM (RdRp), Cy5 (E/N), HEX/VIC (RNase P)

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.6 MB]
; GP_COV2A_Advisory_Notice_EN
pdf, [463.74 kB]
; GP_COV2A_Instruction_for_Use_EN
pdf, [317.76 kB]
; GP_COV2A_Instruction_for_Use_ES
pdf, [313.44 kB]
; GP_COV2A_Instruction_for_Use__FR
pdf, [287.28 kB]
; GP_COV2A_Návod na použitie__SK
pdf, [332.39 kB]

Declaration of Conformity

; GP_COV2A_ Declaration of Conformity_EN
pdf, [618.14 kB]

MSDS

; GP_COV2A_Safety_Data_Sheet_EN
pdf, [274.81 kB]
; GP_SARS-CoV-2A_Safety Data Sheet_EN
pdf, [278.66 kB]

Product Leaflet

; GP_COV2A_Leaflet_EN
pdf, [119.52 kB]
; GP_COVID-19_Solution_leaflet_EN
pdf, [279.35 kB]
Files are available only for registered users.