37.2.1. Overview of Freelite and Hevylite assays on the Optilite
Freelite and Hevylite kits supplied for the Optilite both contain a single vial calibrator, which is diluted automatically by the instrument to generate the calibration curves. The kits also contain two levels of kit-matched control fluid to validate the curves. Hevylite IgGκ and IgGλ kits also contain antigen excess control fluid (Section 37.2.3).
Performance characteristics of Freelite and Hevylite on the Optilite are summarised in Table 37.1. Starting sample dilutions are 1/10 for κ Freelite assays, 1/8 for λ Freelite assays, 1/20 for IgGκ and IgGλ, and 1/10 for all other Hevylite assays. Samples reporting outside of the standard assay measuring range are automatically re-diluted by the instrument to give a final result, for example the range of reportable results for Optilite Freelite κ and λ assays is approximately 0.6 – 127,000 mg/L and 1.3 – 139,000 mg/L, respectively (Section 7.3).
|Range||2.9 - 127 mg/L||5.2 - 139 mg/L||2.3 - 30 g/L||1.5 - 17.5 g/L||0.18 - 11.2 g/L||0.16 - 10.4 g/L||0.2 - 5 g/L||0.18 - 4.5 g/L|
|Sensitivity (neat assay dilution)||0.6 mg/L||1.3 mg/L||0.115 mg/L||0.075 mg/L||0.018 mg/L||0.016 mg/L||0.02 mg/L||0.018 mg/L|
|Assay time||15 min||15 min||22 min||23 min||19 min||19 min||12 min||12 min|
Table 37.1. Analytical performance of Freelite and Hevylite assays on the Binding Site Optilite.