The analytical sensitivity of SPE, CZE and other routine laboratory tests for monoclonal immunoglobulin detection is summarised in Table 4.1. In practice, the detection limit of electrophoretic techniques is dependent on a number of factors including: 1) the position of the monoclonal protein; 2) the level of polyclonal background immunoglobulins (in the γ-region); and 3) the width of the monoclonal protein peak [127]. Not all monoclonal proteins can be accurately quantified by SPE due to co-migration or dye saturation issues (Section 17.4).
SPE | CZE | |||
---|---|---|---|---|
Study | Diagnostic sensitivity (%) | Diagnostic specificity (%) | Diagnostic sensitivity (%) | Diagnostic specificity (%) |
Bossuyt 1998[130] | 86.0 | Not reported | 93.0 | Not reported |
Katzmann 1998 [123] | 90.7 | 98.9 | 94.9 | 98.6 |
Poisson 2012 [124] | 89.9 | 75.4 | 97.4 (or 92.3)* | 57.6 (or 72.2)* |
Yang 2007 [126] | 90.0 | 100 | 81 | 100 |
Table 4.2. Comparison of the diagnostic sensitivity of SPE and CZE to detect monoclonal proteins identified by sIFE. * Values refer to Sebia CAPILLARYSTM2 (or Helena V8TM) instruments.