Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection

摘要

JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis.