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GeneProof SARS-CoV-2 PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

HIGH SPECIFICITY AND SENSITIVITY

  • Excellent QCMD panel results
  • 100% diagnostic sensitivity and specificity

W.H.O. RECOMMENDED DESIGN

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

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

EASY-TO-USE CONCEPT

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

CONTAMINATION PREVENTION

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

MADE IN EU

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

 

Beneficial in Covid-19 • Flu • RSV GPack combination with GeneProof Flu Multiplex PCR Kit.

 

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 PCR Kit COV2/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_COV2_croBEE_QCMD_2020_ EN
pdf, [164.44 kB]
GP_COV2_IRNA_QCMD_2020_EN
pdf, [164.57 kB]
GP_CoV2_QCMD _August_2020_EN
pdf, [161.22 kB]
GP_COV2_QCMD_2020_ EN
pdf, [201.23 kB]
GP_COV2_QCMD_4_2021_EN
pdf, [222.05 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target sequence 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)

GeneProof PathogenFree RNA Isolation Kit FAM 75.49 cp/ml  Cy5 364.82 cp/ml  Qnostics SARS-CoV-2 Medium Q Control

GeneProof Universal Nucleic Acid Extraction Kit  FAM 59.95 cp/ml – Cy5 349.34 cp/ml  Qnostics SARS-CoV-2 Medium Q Control

croBEE 201A Nucleic Acid Extraction Kit  FAM 314.44 cp/ml Cy5 612.27 cp/ml  Qnostics SARS-CoV-2 Medium Q Control

Direct detection (NUCLISWAB® COVID-19 VTM)  FAM, Cy5 519 cp/ml Traceability to Qnostics SARS-CoV-2 Medium Q Control

Diagnostic specificity 100% (CI95%: 95.25% - 100%)
Diagnostic sensitivity 100% (CI95%: 91.58% - 100%)
Positive predictive value 100% (CI95%: 91.58% - 100%)
Negative predictive value 100% (CI95%: 95.25% - 100%)
Extraction/Inhibition Control

PCR inhibition and RNA extraction efficiency control 

Validated Specimen swab, transport medium, saliva
Transport medium: ESwab, UTM, eNAT, PBS, Physiological saline solution, Nuslease-free Water, NUCLISWAB®
COVID-19 VTM, Transport medium (Vircell), Bi-CoVTM set
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
AriaMx Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
LightCycler® 480
LineGene 9600 Plus
Rotor-Gene 3000
Rotor-Gene Q
QuantStudio™ 5 Real-Time PCR System
SLAN® Real-Time PCR System

Required Detection Channels FAM, HEX, Cy5
External Quality Assessment tested in Instand e.V. and QCMD External Quality Assessment Panels - results at www.geneproof.com
Regulatory status CE IVD 

News

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.49 MB]
GP_Advisory Notice_CoV2_CoV2S_CZ_EN
pdf, [399.15 kB]
GP_COV2_Advisory_Notice_EN
pdf, [474.27 kB]
GP_COV2_Instruction for Use_EN
pdf, [277.63 kB]
GP_COV2_Manual de Uso_ES
pdf, [285.69 kB]
GP_COV2_Mode d´emploi_FR
pdf, [305.11 kB]

Declaration of Conformity

GP_COV2_Declaration of conformity_EN
pdf, [554.33 kB]

MSDS

GP_Safety Data Sheet_EN
pdf, [148.84 kB]

PCR Template

GP_COV2_ABI7500
edt, [10.33 kB]
GP_COV2_CFX
prcl, [1.35 kB]
GP_COV2_croBEE
fqt, [4.97 kB]
GP_COV2_LC480
ixo, [9.5 kB]
GP_COV2_RG
ret, [14.88 kB]
GP_FAST_2CH_3CH_AriaMx
amxt, [3.52 kB]
GP_FAST_2CH_3CH_CroBee
fqt, [4.91 kB]
GP_FAST_BioRad
prcl, [1.31 kB]
GP_UNI_3CH_2CH_ABI7500
edt, [10.33 kB]
GP_UNI_3CH_2CH_AriaMx
amxt, [3.64 kB]
GP_UNI_3CH_2CH_CroBee
fqt, [4.9 kB]
GP_UNI_3CH_2CH_QS5
edt, [8.13 kB]
GP_UNI_BioRad
prcl, [1.33 kB]
RG_UNI_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

GP_COV2_Leaflet_EN
pdf, [405.71 kB]
GP_COVID-19_Solution_leaflet_EN
pdf, [528.3 kB]
GP_Covid19_GPack_Leaflet_ EN
pdf, [1.26 MB]

Manual

AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
Files are available only for registered users.

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