During the development of Freelite assays there is a rigorous validation process to ensure that the assays perform correctly and provide the correct diagnostic information. The validation protocols follow those set out by the Clinical and Laboratory Standards Institute, and are outlined in Table 5.1.
|Precision||At multiple levels across the measuring range||Within run, between analyser, between batch, and total precision|
|Analytical sensitivity||At the lower end of the measuring range||Limit of detection, limit of quantitation, and limit of blank|
|Linearity||Across the measuring range||Disease state sera|
|Interference||By the most common assay interferents||Haemoglobin, bilirubin, lipid, relevant drugs etc.|
|Stability||Of kit to determine kit expiry||Real time|
|Of open reagents||On board|
|Of reagents that are removed from the analyser
and refrigerated when not in use
|Of kits that are heated or frozen to mimic
worst case conditions during shipment to customers
|Extremes of temperature|
|Comparison to predicate device||Using a range of samples relevant to the utility of the assay||Healthy blood donors and disease state sera|
|Confirmation of normal reference range||Quoted by the manufacturer||Healthy blood donor sera|
Table 5.1. Summary of Freelite assay validation protocols.