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

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 whole blood. The ipsogen JAK2 RGQ PCR Kit uses polymerase chain reaction (PCR), and ARMS (amplification refractory mutation system) technology on the Rotor-Gene O MDx instrument. Samples are extracted and prepared using the QIAsymphony SP instrument (QSSP) with the QIAsymphony® DSP DNA Mini Kit, followed by assay setup amplification and detection are carried out using the ipsogen JAK2 RGQ PCR Kit with the Rotor-Gene Q MDx and Rotor-Gene AssayManager software version 2.1.x**. Rotor-Gene AssayManager Gamma MDx plug-in installed, version 1.0.x** and an associated JAK2 Assay profile (from file AP ipsogen JAK2 blood US Vx x x**.iap). The extraction step on the OIAsymphony instrument (OSSP) ensures that enough gDNA (of adequate quality) is purified during each run (no repeated extraction for the same sample is expected unless the instrument states that the step failed). The ipsogen JAK2 RGQ PCR Kit is designed to be used with the Rotor-Gene Q MDx (RGO) instrument which is a real-time PCR analyzer designed for rapid thermal cvcling and real-time detection of PCR assays. The Rotor-Gene AssayManager (RGAM) controls and monitors PCR reactions and allows the determination of the mutation status based upon PCR results. The presence of the JAK2 mutation is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes. The probes do not generate a signal unless they are specifically bound to the amplified product. The amplification cycle at which fluorescent signal is detected by the RGO MDx is inversely proportional to the DNA target concentration present in the original specimen. The ipsogen JAK2 RGQ PCR Kit contains reagents for two separate PCR reactions: one mutation-specific reaction and one wild-type specific reaction mix uses a mutant-specific or wild-type specific primer (Reverse primer), together with a common Forward primer and a labeled probe, to amplify and detect the G1849T mutation or the wild-type sequence in the JAK2 gene. In addition, each Reaction Mix contains reagents (unlabeled primers, probe and oligonucleotide template) for an internal control reaction. The internal control is designed to be a reaction that does not compete significantly with the mutation-specific or wildtype specific, reaction mixes. and serve to demonstrate that the entire assay process has proceeded correctly for each specimen. Note: ** x≥ 0, x corresponds to the latest version available on OIAGEN Website