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7.1.5. Changing batch of reagent or instrument

Chapter 7

Great effort is made during Freelite assay manufacture to maintain batch-to-batch consistency (Section 5.5). Moving from one batch to the next should not present the laboratory with any issues. However, it is recommended that identical internal quality control samples are measured with both the new batch and the existing batch to confirm consistency, before moving entirely over to the new batch. 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.