1. Multiplex immunoassay based on biochip technology for the screening of antibiotic residues in milk: validation according to the European guideline
- Author
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Celine Hedou, Valérie Gaudin, Christophe Soumet, Eric Verdon, and Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)
- Subjects
médicament vétérinaire ,analysis ,Danofloxacin ,Health, Toxicology and Mutagenesis ,biochip ,analyse ,veterinary drug ,02 engineering and technology ,chemistry ,Toxicology ,01 natural sciences ,antibiotique ,residues ,chemistry.chemical_compound ,Cloxacillin ,[CHIM.ANAL]Chemical Sciences/Analytical chemistry ,antibiotic ,medicine ,Animals ,False Positive Reactions ,Veterinary drug ,Tilmicosin ,résidus ,sécurité des aliments ,Immunoassay ,milk ,Chromatography ,immunoessai ,010401 analytical chemistry ,Public Health, Environmental and Occupational Health ,General Chemistry ,General Medicine ,021001 nanoscience & nanotechnology ,Thiamphenicol ,lait ,Drug Residues ,Anti-Bacterial Agents ,3. Good health ,0104 chemical sciences ,Lincomycin ,Europe ,food safety ,Virginiamycin ,0210 nano-technology ,Ceftiofur ,Food Science ,medicine.drug - Abstract
International audience; The Infiniplex for milk(R) (IPM) kit is a quick method for the simultaneous and qualitative detection of more than 100 molecules including antibiotic residues, mycotoxins, anti-inflammatories and antiparasitic drugs into a single test that does not require milk treatment. The IPM(R) kit was validated according to the European decision EC/2002/657 and according to the European guideline for the validation of screening methods (2010). Our validation was focused only on antibiotic residues. The washing step was identified as the most critical step of the assay. Insufficient washes could cause a significant background noise that prevents imaging. Positive controls have to be freshly prepared each day (insufficient stability). The method was specific with a low false-positive rate of 1.7% on 5 discrete test regions (DTR) ((beta-lactams, lincomycin, virginiamycin, quinolones and sulphonamides)) and a false-positive rate of 0% on the 26 other DTR. During our validation, the 42 determined detection capabilities CCbeta for 12 antibiotic families (aminoglycosides, cephalosporins, lincosamides, macrolides, miscellaneous antibiotics, penicillins, phenolated polymixins, polypeptide antibiotics, quinolones, sulphonamides, tetracyclines) were at between once and twice the decision levels stated by the manufacturer. Forty CCbeta determined were lower than the respective regulatory limits (i.e. MRL, RC, MRPL) in milk, except for tilmicosin (1.5 times the MRL) and neospiramycin (>1.25 times the MRL). The estimated CCbeta of thiamphenicol, cloxacillin, danofloxacin, sulphathiazol, ceftiofur and sulphamonomethoxine were lower than or at the MRL. However, it was difficult to approach an accurate CCbeta with only qualitative results. It is impossible to know whether or not we were close to the cut-off value. The software could be improved by differentiating between low-positive and high-positive results. The results of our participation in three qualitative proficiency tests in 2016 and 2017 for the detection of quinolones, tetracyclines and sulphonamides in cows' milk were very satisfactory.
- Published
- 2018