The diagnosis of lymphoid malignancy can be a challenge that requires many different disciplines of pathology. Molecular analysis of clonality is a valuable supplementary tool, as in principle, all cells of a malignancy have a common clonal origin.
In this programme participants are provided with lyophilised cell-lines or patient derived material for IgH and TCR clonality analysis. Participants are asked to submit an overall clonality result, based solely on the IgH or TCR loci, together with details of the methodology. Participants are welcome to submit results of other loci and this information will be included in the send-out report but will not be used for scoring. Instructions for storage, reconstitution and use of the lyophilised samples are included with the samples. Three send-outs are issued per annum, with each send-out consisting of two samples, one for IGH analysis and for TCR, alongside a clinical scenario. Periodically, educational Genemapper traces are also distributed for analysis.
Pre issue testing of samples for this programme is subcontracted, although the final decision about sample suitability lies with the EQA provider; no other activities in relation to this EQA programme are subcontracted.