ipsogen JAK2 RGQ PCR Kit CE
For quantitative detection of the JAK2 V617F/G1849T mutation using real-time PCR
IVDD to IVDR transition
A successor version of this kit that complies with the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR) is available.
ipsogen JAK2 RGQ PCR Kit (24) CE
Cat. No. / ID: 673623
For 24 reactions: V617F Positive Control, V617F Negative Control, 2 sets of plasmid standard dilutions JAK2 wild-type and JAK2 V617F, qPCR master-mix including Internal control, 2 Primers and Probe Mixes
ProductSoftware
ipsogen JAK2 RGQ PCR Kit (24) CE
Rotor-Gene AssayManager v2.1 Software
The ipsogen JAK2 RGQ PCR Kit is for in vitro diagnostic use.
References:
Jovanovic, J.V.et al. (2013) Establishing optimal quantitative-polymerase chain reaction assays for routine diagnosis and tracking of minimal residual disease in JAK2-V617F-associated myeloproliferative neoplasms: a joint European LeukemiaNet/MPN&MPNr-EuroNet (COST action BM0902) study. Leukemia 27:2032.
IVDD to IVDR transition
A successor version of this kit that complies with the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR) is available.
Features
- Reliable and sensitive quantification of JAK2 V617F
- An automated workflow from sample to result
- Compliance with EU IVD Directive 98/79/EC
- A master-mix with internal control
- Optimized for the Rotor-Gene Q MDx 5plex HRM
- Larsen’s primers in line with recent international recommendations (1)
Product Details
The ipsogen JAK2 RGQ PCR Kit is an in vitro molecular diagnostic kit for real-time PCR on the Rotor-Gene Q MDx 5plex HRM instrument. The kit provides reagents optimized for reliable and sensitive detection, and clinically validated detection of the JAK2 V617F/G1849T mutation in genomic DNA extracted from peripheral blood of subjects with suspected myeloproliferative neoplasm (MPN).
Performance
To ensure improved sensitivity and reproducibility, the ipsogen JAK2 RGQ PCR Kit is optimized to detect the JAK2 V617F/G1849T mutation and uses prediluted plasmid standards, primers, and probe mixes in line with recent international technical recommendations (1). The sensitivity has a limit of detection (LOD) of 0.042%.
Principle
The ipsogen JAK2 RGQ PCR Kit is a ready-to-use kit for the detection and quantification of the JAK2 V617F/G1849T somatic mutation due to a single nucleotide polymorphism (SNP) in genomic DNA extracted from peripheral blood of subjects with suspected MPN. The kit uses polymerase chain reaction (PCR), and ARMS (amplification refractory mutation system) technology on the Rotor-Gene Q MDx 5plex HRM instrument. The kit is highly sensitive with excellent reproducibility. The ipsogen JAK2 RGQ PCR Kit provides 4 plasmid standard dilutions for each mutant JAK2 V617F and the wild-type JAK2 allele. Use of the standards enables accurate quantification of JAK2 V617F and JAK2 wild-type. Results are expressed as the percentage of JAK2 V617F in total JAK2, as well as mutation detection status based on the LOD.
Procedure
The first step is manual or automated QIAsymphony DSP extraction and determination of quality and quantity of genomic DNA. The second step is the amplification of DNA by real-time PCR, with all needed reagents provided in the kit. The ipsogen JAK2 RGQ PCR Kit detects and quantifies the JAK2 V617F/G1849T mutation on the Rotor-Gene Q MDx 5plex HRM instrument. Finally, the Rotor-Gene AssayManager software is used to interpret the results.
Applications
The ipsogen JAK2 RGQ PCR Kit for in vitro diagnostic use enables sensitive and reliable detection and quantification of the JAK2 V617F/G1849T mutation.
References:
- Jovanovic, J.V., et al. (2013) Establishing optimal quantitative-polymerase chain reaction assays for routine diagnosis and tracking of minimal residual disease in JAK2-V617F-associated myeloproliferative neoplasms: a joint European LeukemiaNet/MPN&MPNr-EuroNet (COST action BM0902) study. Leukemia 27:2032.
Resources
Operating Software (2)
Software User Guides (1)
Kit Handbooks (1)
Instrument User Manuals (2)
Package Insert (1)
Safety Data Sheets (1)
Protocol Files (1)
Certificates of Analysis (1)