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.