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GeneProof® Flu Multiplex PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
MORE INFORMATION WITH LESS SAMPLES
Detects and distinguishes Influenza A, Influenza B and RSV in a single reaction tube
Suitable for differential diagnostics of infectious agents causing Flu and Flu-like symptoms
W.H.O. RECOMMENDED DESIGN
Dual target detection of Influenza A (NP gene/M gene) and Influenza B
EASY-TO-USE CONCEPT
Single tube Ready-to-Use Master Mix contains all components for PCR amplification
No additional PCR reagents pipetting necessary
HIGH SPECIFICITY
Detects all currently known Influenza A serotypes including H1N1, H1N1pdm09, H3N2, H5N8 and H7N
Detects both Influenza B lineages Victoria and Yamagata
Detects RSV A and RSV B
CONTAMINATION PREVENTION
Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible carryover contamination
Combination with GeneProof® SARS-CoV-2 PCR Kit
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
FLU/GP/025 - 25 tests
FLU/GP/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | ▪ Specific region in M gene and NP gene for Influenza A virus ▪ Two specific regions in HA gene for Influenza B virus ▪ Specific region in M gene for Respiratory syncytial virus A and B |
| ANALYTICAL SENSITIVITY (LoD with 95% probability) | ▪ Reaches up to 25.75 cp/ml for Influenza A virus (on INFA Medium Q Control, Qnostics, using manual extraction GeneProof PathogenFree RNA Isolation Kit) ▪ Reaches up to 161.64 cp/ml for Influenza A virus (on INFA Medium Q Control, Qnostics, using automatic extraction croBEE NA16 Nucleic Acid Extraction System) ▪ Reaches up to 7.25 cp/μl for Influenza B virus (on Amplirun® Influenza B RNA control, Vircell) ▪ Reaches up to 43.57 cp/μl for Respiratory syncytial virus (on Amplirun® RSV A RNA control, Vircell) |
| VALIDATED SPECIMEN | Aspirate, BAL, swab, transport medium: Sigma MM, Sigma Virocult |
| VALIDATED EXTRACTION METHODS | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM, HEX, Cy5, TexRed |
| DIAGNOSTIC SENSITIVITY | 92.31 % (CI95%: 80.60 % – 97.51 %) |
| REGULATORY STATUS | CE IVD |
|---|---|
| TYPE OF ANALYSIS | Qualitative |
| ANALYTICAL SPECIFICITY | Influenza A virus, Influenza B virus and Respiratory syncytial virus A and B, 100 % |
| 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 |
| DIAGNOSTIC SPECIFICITY | 100.00 % (CI95%: 79.95 % – 100.00 %) |
| EXTERNAL QUALITY ASSESSEMENT | Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
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 |
