GeneProof Flu Multiplex PCR Kit
Kat.: FLU/GP/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Az Influenza A, Influenza B és RSV elkülönítésére és detektálására alkalmas ‘Ready-to-Use ‘ master mix. Az influenza A (NP gén/M gén) és az influenza B kettős target detektálása. (25 reakció)
Leírás
PRODUCT ADVANTAGES
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
WHO RECOMMENDED DESIGN
- Dual target detection of Influenza A (NP gene/M gene) and Influenza B
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 ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products
Beneficial in Covid-19 • Flu • RSV GPack combination with GeneProof SARS-CoV-2 PCR Kit or GeneProof SARS-CoV-2 Screening PCR Kit
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| Intended User | For professional use in laboratories with trained staff |
| Technology | real-time PCR |
| Type of Analysis | qualitative |
| 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 Specificity | Influenza A virus, Influenza B virus and Respiratory syncytial virus A and B, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 25.75 cp/ml with the probability of 95 % 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 with the probability of 95 % 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 with the probability of 95 % for Influenza B virus (on Amplirun® Influenza B RNA control, Vircell) reaches up to 43.57 cp/μl with the probability of 95 % for Respiratory syncytial virus (on Amplirun® RSV A RNA control, Vircell) |
| Diagnostic Specificity | 100.00% (CI95%: 79.95%–100.00%) |
| Diagnostic Sensitivity | 92.31% (CI95%: 80.60%–97.51%) |
| Extraction/Inhibition Control | PCR inhibition and RNA extraction efficiency control |
| Validated Specimen | aspirate, BAL, swab, transport medium: Sigma MM*, Sigma Virocult* |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree RNA Isolation Kit |
| 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 |
| Required Detection Channels | FAM, HEX, Cy5, TexRed |
| External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
| Certification | CE IVD |
* Only in combination with GeneProof PathogenFree RNA Isolation Kit
** Validated instrument
