Interpretation
Clonal populations of cells yield one (monoclonal), two (clonal) or more (oligoclonal) rearrangements. A normal population of T cells will produce a polyclonal pattern representing a heterogeneous population.
Clonality is determined if the most frequent rearrangement was present at 2.5% or greater and 2-fold that of the polyclonal background.
Reference Intervals
The sensitivity and specificity of this test compared to clinicopathologic information is ~85% and 92% respectively, as assessed by a small in-house verification (n = 26).
Test Method
The T-cell receptor gamma (TRG) gene locus is analysed using multiplex PCR (Lymphotrack TRG assay, Invivoscribe Inc) and next generation sequencing on an Illumina MiSeq instrument. Secondary sequencing analysis is performed using Lymphotrack Dx software.