Analysis of Bovine Lactoferrin in Infant Formula and Adult Nutritional Products by Optical Biosensor Immunoassay: Collaborative Study, Final Action AOAC 2021.07

No Thumbnail Available
File version
Gill, Brendon D
Indyk, Harvey E
Kobayashi, Tadashi
Wood, Jackie E
Clow, Fiona
Dolezal, Olan
Hartley-Tassell, Lauren
Jones, Martina
Kelton, William
Stoller, Robyn
Wilkinson-White, Lorna
Griffith University Author(s)
Primary Supervisor
Other Supervisors
File type(s)


Bovine lactoferrin is increasingly being used as an ingredient in infant formula manufacture to enhance nutritional efficacy through the provision of growth, immunoprotective and antimicrobial factors to the neonate. Objective

To evaluate method reproducibility of AOAC 2021.07 Official First Action method for compliance with the performance requirements described in Standard Method Performance Requirement (SMPR®) 2020.005. Method

Eight laboratories participated in the analysis of blind-duplicate samples of seven nutritional products. Samples were diluted in buffer, and an optical biosensor immunoassay was used in a direct assay format to quantitate bovine lactoferrin by its interaction with an immobilized anti-lactoferrin antibody. Quantitation was accomplished by the external standard technique with interpolation from a 4-parameter calibration regression. Results

After outliers were removed, precision as reproducibility was found to be within limits set in SMPR 2020.005 (≤ 9%) for six out of seven samples and all had acceptable HorRatR values ranging from 1.0 to 2.1. Additionally, comparison with an alternative independent Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) First Action method (heparin clean-up LC UV), showed negligible difference between results. Conclusions

The method described is suitable for the quantification of intact, undenatured bovine lactoferrin in powdered infant formulas. The SPIFAN Expert Review Panel evaluated the method and accompanying validation data from this multi-laboratory testing study in July 2023 and recommended Official Method 2021.07 for adoption as a Final Action Official Method. Highlights

A multi-laboratory validation study of an automated optical biosensor immunoassay for the determination of intact, undenatured bovine lactoferrin is described.

Journal Title

Journal of AOAC International

Conference Title
Book Title
Thesis Type
Degree Program
Publisher link
Patent number
Grant identifier(s)
Rights Statement
Rights Statement
Item Access Status

This publication has been entered in Griffith Research Online as an advance online version.

Access the data
Related item(s)
Persistent link to this record

Gill, BD; Indyk, HE; Kobayashi, T; Wood, JE; Clow, F; Dolezal, O; Hartley-Tassell, L; Jones, M; Kelton, W; Stoller, R; Wilkinson-White, L, Analysis of Bovine Lactoferrin in Infant Formula and Adult Nutritional Products by Optical Biosensor Immunoassay: Collaborative Study, Final Action AOAC 2021.07, Journal of AOAC International, 2024