ipsogen JAK2 RGQ PCR Kit – IVDR

For quantitative detection of the JAK2 V617F/G1849T mutation using real-time PCR

S_1123_9_ipsogenJAK2RGQPCR

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ipsogen JAK2 RGQ PCR Kit

Cat. No. / ID: 674623

For 24 reactions: Wild-type JAK2 Gene Control, JAK2 V617F Control Gene, JAK2 WT Quant Standards, JAK2 MT Quant Standards, JAK2 WT Reaction Mix, JAK2 MT Reaction Mix, Taq DNA polymerase, TE buffer for dilution, water for NTC
KitSoftware
ipsogen JAK2 RGQ PCR Kit
Rotor-Gene AssayManager v2.1 Software
Rotor-Gene AssayManager v2.1 License
The ipsogen JAK2 RGQ PCR Kit is for in vitro diagnostic use. QIAGEN is the exclusive licensee of intellectual property rights that cover the detection of V617F JAK2 mutation for diagnostic purposes. These intellectual property rights contain granted European patent EP 1 692 281 and corresponding patents and pending patent applications in other countries.

✓ 24/7 automatic processing of online orders

✓ Knowledgeable and professional Product & Technical Support

✓ Fast and reliable (re)-ordering

Features

  • Fulfills the high-quality, analytical and clinical performance standards in compliance with European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR)
  • Reliable and sensitive quantification of JAK2 V617F/G1849T allele, a major diagnostic criterion for MPN according to the WHO guidelines (1)
  • An automated workflow from sample to result
  • All-in-one, ready-to-use kit, including reaction mixes and internal control
  • Easy-to-use protocols validated on QIAsymphony SP and automated interpretation with Rotor-Gene AssayManager v2.1
  • Larsen’s primers in line with international recommendations (2)

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 fulfills the requirements of the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR). This in vitro diagnostic PCR assay is for reliable and sensitive quantitative detection of the JAK2 V617F/G1849T mutation in gDNA from human peripheral whole blood anticoagulated with K2-EDTA.

Results obtained with the ipsogen JAK2 RGQ PCR Kit are intended for use as an adjunct to evaluation of suspected philadelphia (ph) chromosome negative myeloproliferative neoplasm (MPN) and molecular disease monitoring in MPN patients. Any diagnostic results generated must be interpreted in conjunction with other clinical-pathological findings.

Performance

This is an enhanced version of the kit that has undergone a program to fulfill the IVDR requirements.

For details on the performance, refer to the “Performance Characteristics” section of the ipsogen JAK2 RGQ PCR Kit Handbook.

Analytical 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 international technical recommendations (2). The limit of blank (LOB) measured using the ipsogen JAK2 RGQ PCR Kit corresponds to the expected value in a normal population (0%). The analytical sensitivity has a limit of detection (LOD) of 0.042% and the limit of quantification (LOQ) is 0.233% of the JAK2 V617F mutation.

The ipsogen JAK2 RGQ PCR Kit was tested with WHO International Reference Panel for Genomic JAK2 V617F (NIBSC, panel code 16/120[VLQ1] ). Concordance is confirmed, demonstrating the suitability of the kit in providing JAK2 V617F data that are in agreement with other commonly used diagnostic techniques (see figure “Concordance between the ipsogen JAK2 RGQ PCR Kit results and the WHO International Reference Panel for Genomic JAK2 V617F”).

Clinical performance

The clinical performance of the ipsogen JAK2 RGQ PCR Kit was evaluated in a multicenter, international, prospective, interventional study with 216 participants with suspected polycythemia vera (PV). Using the ipsogen JAK2 RGQ PCR Kit for PV diagnosis, the sensitivity was 94.64% and the specificity was 95.62%. This demonstrates that the ipsogen JAK2 RGQ PCR Kit enables detection of PV in the vast majority of subjects with the disease, and helps rule out the disease in the vast majority of subjects without PV.



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 or diagnosed MPN. The kit uses polymerase chain reaction (PCR) and exploits the qPCR oligonucleotide hydrolysis principle 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 QIAamp DSP DNA Blood Mini Kit 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 simplifies data analysis and management, and maximizes process safety for efficient and timely result reporting.

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.

For JAK2 V617F detection and quantification as an adjunct to evaluation of suspected Ph- MPN and molecular disease monitoring in MPN patients.

 

References:
1. Arber, D.A. et al. (2016) The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood 127, 2391.
2. 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.

Supporting data and figures

Resources

Operating Software (2)
To download Rotor-Gene AssayManager v2.1.1 after purchase:
    Click the Rotor-Gene AssayManager v2.1.1 Software header. On the next window, click Continue. Follow the on-screen instructions to install Rotor-Gene AssayManager v2.1.1.
    Rotor-Gene AssayManager v2.1.1 and license must be purchased prior to use.    

    IMPORTANT: In order to perform and analyze runs, at least one Rotor-Gene AssayManager v2.1.1 plug-in needs to be installed. Refer to your assay kit handbook for more information.

    IMPORTANT: To allow checksum integrity verification, use the value D24F10DEB7A1D60EE381E2AEA8789117D0980FCC.

To purchase a license key for Rotor-Gene AssayManager v2.1.1:
    1. After purchasing Rotor-Gene AssayManager v2.1.1 software and licenses, click the "Download" button and follow the onscreen instructions to install. After successful installation of the Rotor-Gene AssayManager v2.1.1 and a plug-in, a “key file” will be generated. This "key file" will be attached to the "Technical Support Form" in Step 5, below.   
    2. Go to the Technical Support Form. Make sure to include all required information and your Rotor-Gene Q or Rotor-Gene Q MDx serial number when filling out the form.       
    3. For Question 2, "Type of Request", select “Other”.
    4. For Question 4, “Your inquiry”, enter "Rotor-Gene AssayManager license request” and include your purchase order number, from your order confirmation.
    5. Include the "key file" from Step 1 as an attachment.
    6. Submit the form. QIAGEN Technical Services will respond via email with a license file within 1–2 working days.    
    7. After receiving your computer-specific Rotor-Gene AssayManager v2.1.1 license file, archive the license file locally on your computer.

IMPORTANT: The license file must always exist on the computer that has Rotor-Gene AssayManager v2.1.1 installed. The license file location should be protected and not subject to change.





Gamma Plug-in for use with Rotor-Gene AssayManager v2.1
Safety Data Sheets (1)
Protocol Files (1)
Version 2.0.1
Software User Guides (1)
For use with Rotor-Gene AssayManager v2.1 Gamma Plug-in
Instrument User Manuals (2)
For use with Rotor-Gene AssayManager v2.1 Software
For installation and setup of Rotor-Gene AssayManager v2.1
Kit Handbooks (2)
For use with ipsogen JAK2 RGQ PCR Kit

July 2022
For in vitro diagnostic use
For use with Rotor-Gene  Q MDx 5plex HRM instrument

July 2022

Publications

The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia.
Arber DA; Orazi A; Hasserjian R; Thiele J; Borowitz MJ; Le Beau MM; Bloomfield CD; Cazzola M; Vardiman JW;
Blood; 2016; 127 (20):2391-405 2016 Apr 11 PMID:27069254
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.
Jovanovic JV; Ivey A; Vannucchi AM; Lippert E; Oppliger Leibundgut E; Cassinat B; Pallisgaard N; Maroc N; Hermouet S; Nickless G; Guglielmelli P; van der Reijden BA; Jansen JH; Alpermann T; Schnittger S; Bench A; Tobal K; Wilkins B; Cuthill K; McLornan D; Yeoman K; Akiki S; Bryon J; Jeffries S; Jones A; Percy MJ; Schwemmers S; Gruender A; Kelley TW; Reading S; Pancrazzi A; McMullin MF; Pahl HL; Cross NC; Harrison CN; Prchal JT; Chomienne C; Kiladjian JJ; Barbui T; Grimwade D;
Leukemia; 2013; 27 (10):2032-9 2013 Jul 17 PMID:23860450