Qiagen, 673633, ipsogen JAK2 RGQ PCR Kit (24)

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

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

Performance

* 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.

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.