x IgG HLC: 143 normal sera and 216 IgG MM patient sera (121 IgGκ and 95 IgGλ); IgA HLC: 138 normal sera and 94 IgA MM patient sera (58 IgAκ and 36 IgAλ); IgM HLC: 110 normal sera and 78 sera from patients with IgM monoclonal gammopathies.
x IgG HLC: 143 normal sera and 216 IgG MM patient sera (121 IgGκ and 95 IgGλ); IgA HLC: 138 normal sera and 94 IgA MM patient sera (58 IgAκ and 36 IgAλ); IgM HLC: 110 normal sera and 78 sera from patients with IgM monoclonal gammopathies.
During validation, a detailed comparison study is performed for each assay: summated concentrations of HLC immunoglobulin pairs (e.g. IgAκ + IgAλ) are compared with total immunoglobulin measurements (e.g. IgA) as a test of assay accuracy. All specificities demonstrate a high degree of correlation, and the results are summarised in each product insert. An example is shown in
Figure 9.9.
