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GeneProof SARS-CoV-2 PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

UNIQUE 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

MADE IN EU

  • Developed and manufactured in the Czech Republic, the member of the European Union

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

 

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_QCMD_07_21_EN
pdf, [233.96 kB]
GP_COV2_QCMD_10_21_EN
pdf, [233.08 kB]
GP_COV2_Instand_03_21_EN
pdf, [1.02 MB]
GP_COV2_Instand_06_21_EN
pdf, [1 MB]
GP_COV2_QCMD_4_2021_EN
pdf, [222.05 kB]
GP_COV2_IRNA_QCMD_2020_EN
pdf, [164.57 kB]
GP_COV2_croBEE_QCMD_2020_ EN
pdf, [164.44 kB]
GP_CoV2_QCMD _August_2020_EN
pdf, [161.22 kB]
GP_COV2_QCMD_2020_ EN
pdf, [201.23 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 gene, E gene and N gene
Analytical Specificity SARS-CoV-2, 100 %
Analytical Sensitivity (LoD with 95% Probability)

Sample Processing 

Sensitivity Material
GeneProof PathogenFree RNA Isolation Kit (FAM) 381.28 IU/ml PBS
croBEE 201A Nucleic Acid Extraction Kit (FAM) 1600.41 IU/ml PBS
Direct detection (Bi-CoV®) (FAM) 2589.8 IU/ml Anterior nasal swab in Bi-CoV®
Diagnostic specificity 100% (CI95%: 95.68% - 100%)
Diagnostic sensitivity 100% (CI95%: 91.58% - 100%)
Positive predictive value 100% (CI95%: 91.58% - 100%)
Negative predictive value 100% (CI95%: 95.68% - 100%)
Reporting Units IU/ml
Metrological Traceability 1st WHO International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146)
Extraction/Inhibition Control

PCR inhibition and RNA extraction efficiency control by Internal Control (IC)

Validated Specimen Nasopharyngeal swab in transport media UTM (Copan), PBS or physiological saline solution
Anterior nasal swab, saliva in Bi-CoV®
Anterior nasal swab in nuclease-free water (NFW)
Storage -20 ± 5 °C
Validated Extraction Methods ccroBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree RNA Isolation Kit
Instruments

croBEE Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System
AMPLilab Real-Time PCR System
AriaMx Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR 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/JOE/VIC, Cy5
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com

News

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.55 MB]
GP_Advisory Notice_CoV2_CoV2S_CZ_EN
pdf, [399.15 kB]
GP_COV2_Advisory_Notice_01_22_EN_CZ
pdf, [546.98 kB]
GP_COV2_Advisory_Notice_EN
pdf, [474.27 kB]
GP_COV2_Instruction for Use_EN
pdf, [286.07 kB]

Declaration of Conformity

GP_COV2_Declaration of conformity_EN
pdf, [554.33 kB]

MSDS

GP_COV2_Safety_Data_Sheet_EN
pdf, [286 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, [240.86 kB]
GP_COVID-19_Solution_leaflet_EN
pdf, [279.35 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.