7.1.5. Changing reagent lot or instrument

Chapter 7

Great effort is made during Freelite assay manufacture to maintain lot-to-lot consistency (Section 5.5). Moving from one lot to the next should not present the laboratory with any issues. Correlation of Freelite sFLC measurements obtained using different platforms is good (Section 5.8) [965]. However, before a laboratory changes platform, it is recommended that they compare the results obtained using the new and existing platforms as part of their validation protocol.