Chapter 39

In May 2013 the Binding Site launched a pilot quality assurance scheme for Hevylite analysis (QA003.H). Four samples are distributed each year and over 40 laboratories currently participate in the scheme. The scheme requires samples to be initially screened by SPE and sIFE, followed by Hevylite assays with the HLC pair selected as indicated by the immunofixation results. Participants receive a comprehensive report that includes analysis of qualitative results for SPE/sIFE and quantitative results for HLC assays that correspond with the monoclonal intact immunoglobulin type. Examples from a typical report are shown in Figures 39.4 and 39.5.