Validation of a Dissociation Enhanced Lanthanide Fluorescence Immunoassay for the Screening of 17 -Estradiol in Bovine Serum According to European Union Decision 2002/657/EC

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Abstract:

A validation study was carried out in order to evaluate the performances of a dissociation enhanced lanthanide fluorescence immunoassay (DELFIA) for rapid screening of 17 -Estradiol in bovine serum. This validation was performed according to European Union (EU) Decision 2002/657/EC, which establishes criteria and procedures for determination of detection capability (CC), selectivity/specificity, and applicability/ruggedness/stability for qualitative screening tests. To determine these performance characteristics, 20 blank serum samples of cattle were collected and spiked with 17 -Estradiol at 40 pg/mL, corresponding to the maximum residue limit permitted by Italian legislation. According to the EU Decision CC criterion, spiked samples must have <5 probability to be classified as a false negative. 17 -Estradiol was detected in each spiked sample, and the CC results were <40 pg/mL. There was also no observed interference effect due to chemically related substances or from the matrix. Moreover, slight variations of some critical factors in the DELFIA procedure, deliberately introduced for ruggedness evaluation, did not result in any negative effect on the 17 -Estradiol detection. The proposed method is suitable for qualitative screening analysis of 17 -Estradiol according to EU performance requirements.

Document Type: Research Article

Affiliations: Institute Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d'Aosta I. Altara, Via Bologna, 148, 10154 Torino, Italy.

Publication date: September 1, 2007

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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