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GeneProof® SARS-CoV-2 Advanced PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
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
COV2A/GP/025 - 25 tests
COV2A/GP/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | RdRp/E/N genes |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control |
| STORAGE | (-20 ± 5) °C |
| INSTRUMENTS | ▪ ccroBEE Real-Time PCR System Applied Biosystems 7500 Real-Time PCR System ▪ CFX96/ Dx Real-Time PCR Detection System ▪ AriaMx Real-Time PCR System ▪ LineGene 9600 Plus |
| EXTERNAL QUALITY ASSESSEMENT | Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
| REGULATORY STATUS | CE IVD |
|---|---|
| TYPE OF ANALYSIS | Qualitative |
| ANALYTICAL SPECIFICITY | SARS-CoV-2, 100 % |
| VALIDATED SPECIMEN | BAL, sputum, swab |
| VALIDATED EXTRACTION METHODS | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM, HEX |
Service and Warranty
GENEPROOF CALCULATOR
The on-line calculator was developed by GeneProof to simplify the evaluation of GeneProof quantitative PCR kits.
To access the online calculator, click the button below
If you have any questions, please contact our specialists on the CONTACTS page.
We provide premium service and maintenance for every device and consumable:
• Comprehensive maintenance of medical equipment
• Installations, commissioning
• Warranty and post-warranty service
• Instruction, training and consultations for your team
More details on the SERVICE page
| Contact phone | +38 (067) 133 05 52 |
|---|---|
| E-mail: | service@empirica.healthcare |
