Acquired genetic alteration IVDs

Intended purpose

The ipsogen JAK2 RGQ PCR Kit is a quantitative in vitro PCR assay intended for the detection and quantitation of the JAK2 V617F/G1849T mutation in genomic DNA extracted from human peripheral whole blood anticoagulated with 2K-EDTA. Results obtained with the ipsogen JAK2 RGQ PCR Kit are intended for use as an adjunct to evaluation of suspected Philadelphia (Ph) chromosome negative myeloproliferative neoplasm (MPN) and molecular disease monitoring in MPN patients. Any diagnostic results generated must be interpreted in conjunction with other clinical-pathological findings. The ipsogen JAK2 RGQ PCR Kit is intended to be used only with the QIAGEN Rotor-Gene Q MDx 5plex HRM instrument and other validated workflow components as outlined in the instructions for use. The ipsogen JAK2 RGQ PCR Kit is not an automated device, however, the analysis is assisted by a dedicated software. The ipsogen JAK2 RGQ PCR Kit is intended for in vitro diagnostic use.