Evidence map›Paper›PMID 38704865›Full record

ArticleJournal of AOAC International2024

Determination of Bovine Lactoferrin in Powdered Infant Formula and Adult Nutritionals by Heparin Affinity Extraction and Reverse-Phase High-Performance Liquid Chromatography/Ultraviolet Detection (HPLC/UV): Single-Laboratory Validation, First Action 2021.10.

Jennifer L Frueh, Peng Shu, Thomas R Vennard, Michael A Gray, Shay C Phillips

Abstract readValidation Study
In one paragraph

Article in Journal of AOAC International, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Jennifer L FruehReckitt/Mead Johnson Nutrition, 2400 West Lloyd Expressway, Evansville, IN 47721, United States.ORCID 0000-0002-2239-4923
Peng ShuReckitt/Mead Johnson Nutrition, 2400 West Lloyd Expressway, Evansville, IN 47721, United States.ORCID 0000-0003-1828-1149
Thomas R VennardReckitt/Mead Johnson Nutrition, 2400 West Lloyd Expressway, Evansville, IN 47721, United States.ORCID 0000-0002-9193-3433
Michael A GrayReckitt/Mead Johnson Nutrition, 2400 West Lloyd Expressway, Evansville, IN 47721, United States.ORCID 0000-0001-8850-1990
Shay C PhillipsReckitt/Mead Johnson Nutrition, 2400 West Lloyd Expressway, Evansville, IN 47721, United States.ORCID 0000-0002-5767-014X

Funding

Mead Johnson NutritionReckitt
6 · The paper itself

Abstract

backgroundInfant formulas, and pediatric and adult nutritional products, are being fortified with bovine lactoferrin (bLF) due to its beneficial impacts on immune development and gut health. Lactoferrin supplementation into these products requires an analytical method to accurately quantify the concentrations of bLF to meet global regulatory and quality standards.

objectiveTo develop and validate a lactoferrin method capable of meeting the AOAC INTERNATIONAL Standard Method Performance Requirements (SMPR®) 2020.005.

methodsPowder formula samples are extracted using warm dibasic phosphate buffer, pH 8, then centrifuged at 4°C to remove insoluble proteins, fat, and other solids. The soluble fraction is further purified on a HiTrap heparin solid-phase extraction (SPE) column to isolate bLF from interferences. Samples are filtered, then analyzed by LC-UV using a protein BEH C4 analytical column and quantitated using an external calibrant.

resultsThe LOQ (2 mg/100 g), repeatability (RSD: 2.0-4.8%), recovery (92.1-97.7%), and analytical range (4-193 mg/100 g) all meet the method requirements as stated in SMPR 2020.005 for lactoferrin.

conclusionThe reported single-laboratory validation (SLV) results demonstrate the ability of this lactoferrin method to meet or exceed the method performance requirements to measure soluble, intact, non-denatured bLF in infant and adult nutritional powder formulas. HIGHLIGHTS: The use of a heparin affinity column to isolate lactoferrin from bovine milk products combined with a selective analytical chromatographic column provides suitable analyte specificity without requiring proprietary equipment or reagents.

Indexed as

Infant FormulaLactoferrinAdultAnimalsCattleChromatography, AffinityChromatography, High Pressure LiquidChromatography, Reverse-PhaseFood, FormulatedHeparinHumansInfantPowdersReproducibility of ResultsSolid Phase ExtractionSpectrophotometry, UltravioletHeparinLactoferrinPowders

Identifiers

PMID38704865
PMCPMC11223759

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.