AOAC Guidance on FA Immunoassay Validation (August 2023)

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4.3.2. Make a high-level suspension of allergen in water, PBS or similar dilution buffer. It will be critical to ensure that the suspension is well mixed, and a representative portion is used for subsequent dilutions or addition to the test portion. The expected value for the spiked sample

will be calculated based on the gravimetric preparation of the suspension.

4.3.3. The high-level suspension should not make up more than 10% of the final test portion, to

ensure that the sample is representative.

4.3.4. A recommended starting concentration for the stock solution is 1 mg/mL. In all cases, the method chosen for preparation of the spike and the spiking method should be documented in

the validation report.

References

1. Taylor, S.L., Nordlee, J.A., Niemann, L.M., & Lambrecht, D.M. (2009) Anal. Bioanal. Chem. 395 ,

83-92