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
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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