ipsogen JAK2 RGQ PCR Kit

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

Products

The ipsogen JAK2 RGQ PCR Kit is intended for use in diagnostic procedures. For prescription use only. References: Arber, D.A. et al. (2016) The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood 127, 2391.
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ipsogen JAK2 RGQ PCR Kit (24)

Cat. No. / ID:   673633

For 24 samples: 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
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Rotor-Gene AssayManager v2.1

Cat. No. / ID:   9024203-US

Software for routine testing in combination with Rotor-Gene Q MDx instruments. IMPORTANT: Does not include license for use. License key must be purchased separately. Visit the Download Page for download, installation and licensing instructions.

Features

  • Only FDA-cleared JAK2 PCR kit on the market
  • Reliable detection of the JAK2 V617F/G1849T allele, a major diagnostic criterion for MPN according to the WHO guidelines (1)
  • Highly sensitive and specific
  • All-in-one, ready-to-use kit including QIAGEN master-mix and internal control
  • Optimized for the Rotor-Gene Q MDx (US) instrument
  • Automated solution using QIAsymphony SP and Rotor-Gene AssayManager v2.1 for analysis

Product Details

The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The test is a real-time PCR assay performed on the QIAGEN Rotor-Gene Q MDx (US) instrument. The ipsogen JAK2 test is intended for use as an adjunct to the evaluation of suspected myeloproliferative neoplasms (MPNs), in conjunction with other clinicopathological factors. This test does not detect less common JAK2 mutations associated with MPNs, including mutations in exon 12, and is not intended for standalone diagnosis of MPNs.

Performance

The clinical performance of the ipsogen JAK2 assay in the diagnosis of PV was evaluated in a multicenter, international, prospective, interventional study enrolling over 200 patients. Using the ipsogen JAK2 RGQ PCR Kit for polycythemia vera (PV) diagnosis, the sensitivity was 94.6% and the specificity was 98.1%.* 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. The concordance of JAK2 V617F mutation detection with bi-directional sequencing (BDS) and NGS was also assessed on gDNA samples extracted from a total of 473 specimen: 276 with suspected PV, 98 with essential thrombocythemia (ET) and 99 with primary myelofibrosis (PMF). The ipsogen JAK2 RGQ PCR assay was 100% accurate for the detection of JAK2 V617F allele in specimen from subjects with JAK2 V617F levels ≥1%.

* The calculation of sensitivity and specificity includes 4 cases with inconclusive bone marrow histologies as well as 2 discordant cases. For the discordant cases, the investigator used clinical discretion deviating from the WHO diagnostic algorithm for the diagnosis of PV. For further details, refer to the ‘clinical performance’ section of the ipsogen JAK2 kit handbook.

Principle

The ipsogen JAK2 RGQ PCR Kit uses TaqMan polymerase chain reaction (PCR) probes and ARMS (Amplification Refractory Mutation System) technology on the Rotor-Gene Q MDx (US) instrument for sensitive and specific JAK2 V617F mutation analysis. Results are expressed as mutation detection status based on a ≥ 1% mutant allele frequency cut-off. The percent mutant allele burden of JAK2 V617F in total JAK2 wildtype is reported by means of corresponding quantitation curves. Performance is ensured by wildtype and mutant positive and negative controls for every run, and by an internal control in a separate fluorescence channel for every sample.

Procedure

The ipsogen JAK2 RGQ PCR Kit provides an automated workflow from blood sample to result in less than 4 hours with easy-to-use protocols validated on the QIAsymphony SP and Rotor-Gene Q MDx (US) instruments. Ready-to-use solutions and a QIAGEN PCR master mix are included in the kit for rapid qualitative analysis of the JAK2 V617F/ G1849T mutation for up to 24 samples per run. Finally, the Rotor-Gene AssayManager software simplifies data analysis and management, and maximizes process safety for efficient and timely result reporting.

Applications

JAK2 V617F is a major diagnostic criterion for myeloproliferative neoplasms (MPNs) according to the WHO guidelines (1).

The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The test is a real-time PCR assay performed on the QIAGEN Rotor-Gene Q MDx (US) instrument. The ipsogen JAK2 test is intended for use as an adjunct to the evaluation of suspected myeloproliferative neoplasms (MPNs), in conjunction with other clinicopathological factors. This test does not detect less common JAK2 mutations associated with MPNs, including mutations in exon 12, and is not intended for standalone diagnosis of MPNs.

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.





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Safety Data Sheets (1)
Certificates of Analysis (1)