Description
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.
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.
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.
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.
