image

5.6. Overview of Freelite assay validation

Chapter 5

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.

Validation Comments Validation protocol
PrecisionAt multiple levels across the measuring range Within run, between analyser, between batch, and total precision
Analytical sensitivityAt the lower end of the measuring range Limit of detection, limit of quantitation, and limit of blank
LinearityAcross the measuring range Disease state sera
InterferenceBy the most common assay interferents Haemoglobin, bilirubin, lipid, relevant drugs etc.
StabilityOf 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
Open vial
Of kits that are heated or frozen to mimic
worst case conditions during shipment to customers
Extremes of temperature
Comparison to predicate deviceUsing a range of samples relevant to the utility of the assay Healthy blood donors and disease state sera
Confirmation of normal reference rangeQuoted by the manufacturer Healthy blood donor sera

Table 5.1. Summary of Freelite assay validation protocols.