Lot to Lot Variability

Great effort is made during Freelite assay manufacture to maintain batch-to-batch consistency of our polyclonal reagents.

This is achieved by:

• Use of large rolling pools of polyclonal antisera which include over 200 immunisations per pool
• Minimal variation in constituent antisera between consecutive lots (< 5%)
• Testing of panels of samples (including normal sera, sera with elevated polyclonal FLC and Multiple Myeloma sera) with every new batch of reagent. Results are compared against previous lots, and must be shown to be comparable in accordance with strict production criteria.

Moving from one batch to the next should not present the laboratory with any issues.