333
Views
4
CrossRef citations to date
0
Altmetric
Review

State of the art in the validation of screening methods for the control of antibiotic residues: is there a need for further development?

Pages 1528-1552 | Received 16 Mar 2017, Accepted 13 Jun 2017, Published online: 14 Jul 2017

References

  • 93/256/EEC. 1993. Commission Decision of 14 April 1993 laying down the methods to be used for detecting residues of substances having a hormonal or a thyrostatic action. Off J Eur Community. L 118:0064–0074.
  • Abouzied M, Driksna D, Walsh C, Sarzynski M, Walsh A, Ankrapp D, Klein F, Rice J, Mozola M. 2012. Validation study of the betastar® plus lateral flow assay for detection of beta-lactam antibiotics in milk. J AOAC Int. 95:1211–1221.
  • Abouzied M, Sarzynski M, Walsh A, Wood H, Mozola M. 2009. Validation study of a receptor-based lateral flow assay for detection of beta-lactam antibiotics in milk performance-tested method SM 030802. J AOAC Int. 92:959–974.
  • AFNOR. 2005. Validation AFNOR des méthodes alternatives d’analyse – Application à la détection des résidus d’antibiotiques et autres molécules à effet antibactérien dans les produits agroalimentaires - Exigences relatives aux études préliminaire et collaborative menées par un laboratoire expert. Vol. Révision 0:1–13.
  • AOAC INTERNATIONAL. 2014. Guidelines for validation of qualitative binary chemistry methods. J AOAC Int. 97:1492–1495.
  • Bjurling P, Baxter GA, Caselunghe M, Onson C, Oconnor M, Persson B, Elliott CT. 2000. Biosensor assay of sulfadiazine and sulfamethazine residues in pork. Anal. 125:1771–1774.
  • Bouabidi A, Rozet E, Fillet M, Ziemons E, Chapuzet E, Mertens B, Klinkenberg R, Ceccato A, Talbi M, Streel B, et al. 2010. Critical analysis of several analytical method validation strategies in the framework of the fit for purpose concept. J Chromatogr A. 1217:3180–3192.
  • Bouabidi A, Talbi M, Bourichi H, Bouklouze A, El Karbane M, Boulanger B, Brik Y, Hubert P, Rozet E. 2012. Flexibility and applicability of β-expectation tolerance interval approach to assess the fitness of purpose of pharmaceutical analytical methods. Drug Test Anal. 4:1014–1027.
  • Bourdat-Deschamps M. 2010. Validation de l’analyse des hydrocarbures aromatiques polycycliques dans les eaux de pluie par la méthode du profil d’exactitude. Le Cahier des Techniques de l’Inra. 85–98. No Spécial “Validation des méthodes d’analyse quantitative par le profil d’exactitude.”
  • Caporal-Gautier J, Nivet JM. 1992a. Guide de validation analytique : rapport d'une commission sfstp - i : méthodologie. S.T.P. Pharma Pratiques Techniques Reglementations. 2:205–226.
  • Caporal-Gautier J, Nivet JM, Algranti P, Guilloteau M, Histe M, Lallier M, N'Guyen-Huu JJ, Russotto R. 1992b. Guide to analytical validation. Report of an SFSTP commission. II. Examples of application. STP Pharma Pratiques. 2:227–239.
  • Chéneau E, Henri J, Pirotais Y, Abjean J-P, Roudaut B, Sanders P, Laurentie M. 2007. Liquid chromatography–electrospray tandem mass spectrometric method for quantification of monensin in plasma and edible tissues of chicken used in pharmacokinetic studies: applying a total error approach. J Chromatogr B. 850:15–23.
  • Chevallier E, Chekri R, Zinck J, Guérin T, Noël L. 2015. Simultaneous determination of 31 elements in foodstuffs by ICP-MS after closed-vessel microwave digestion: method validation based on the accuracy profile. J Food Composition Anal. 41:35–41.
  • Cloke J, Evans K, Crabtree D, Hughes A, Simpson H, Leon-Velarde C, Larson N, Dave K, Holopainen J, Wickstrand N, et al. 2015. Method modification of the thermo scientific SureTect listeria monocytogenes assay for raw meat, dairy, produce, and seafood. J AOAC Int. 98:1315–1324.
  • Commission Decision (EC) N° 2002/657. 2002. of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and interpretation of results. Off J Eur Commun. L221:8–36.
  • Commission Regulation (EC) N° 470/2009. 2009a. laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. Off J Eur Union. L152:11–22.
  • Council directive 96/23/EC. 1996a. of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC. L125:10–32.
  • Council Regulation (EU) (2010) N 37/2010. 2009b. of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin. Off J Eur Union. L15:1–72.
  • Crabbe P, Vanpeteghem C. 2002. Rapid and sensitive screening of sulfamethazine in porcine urine with an enzyme-linked immunosorbent assay and a field-portable immunofiltration assay. J Food Prot. 65:820–827.
  • CRL. 2010. Guideline for the validation of screening methods for residues of veterinary medicines (initial validation and transfer):1–18. http://ec.europa.eu/food/food/chemicalsafety/residues/lab_analysis_en.htm: Guideline_Validation_Screening_en.pdf.
  • De Rijk A. 2006. Method validation study report. AOAC Performance tested methods 2006-02-23. Method / Kit Title: Premi®Test.
  • Directive 96/23/CE DU. 1996b. CONSEIL du 29 avril 1996 relative aux mesures de contrôle à mettre en oeuvre à l’égard de certaines substances et de leurs résidus dans les animaux vivants et leurs produits et abrogeant les directives 85/358/CEE et 86/469/CEE et les décisions 89/187/CEE et 91/664/CEE. Journal Officiel Des Communautés Européennes. L125:10–32.
  • Feinberg M. 2007. Validation of analytical methods based on accuracy profiles. J Chromatogr A. 1158:174–183.
  • Feinberg M, Boulanger B, Dewé W, Hubert P. 2004. New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data. Anal. Bioanal. Chem. 380:502–514.
  • Feinberg M, Sohier D, David J-F. 2009. Validation of an alternative method for counting enterobacteriaceae in foods based on accuracy profile. J AOAC Int. 92:527–537.
  • Ferguson JP, Baxter GA, McEvoy JDG, Stead S, Rawlings E, Sharman M. 2002. Detection of streptomycin and dihydrostreptomycin residues in milk, honey and meat samples using an optical biosensor. Anal. 127:951–956.
  • Galarini R, Buratti R, Fioroni L, Contiero L, Lega F. 2011. Development, validation and data quality assurance of screening methods: a case study. Anal. Chim Acta. 700:2–10.
  • Gaudin V, Fontaine J, Maris P. 2001. Screening of penicillin residues in milk by a surface plasmon resonance. Anal Chim Acta. 436:191–198.
  • Gaudin V, Gaugain-Juhel M, Moretain JP, Sanders P. 2008. AFNOR validation of Premi®Test, a microbiological-based screening tube-test for the detection of antimicrobial residues in animal muscle tissue. Food Addit Contam Part A. 25:1451–1464.
  • Gaudin V, Hedou C, Rault A, Sanders P, Verdon E. 2009. Comparative study of three screening tests, two microbiological tube tests, and a multi-sulphonamide ELISA kit for the detection of antimicrobial and sulphonamide residues in eggs. Food Addit Contam Part A. 26:427–440.
  • Gaudin V, Hedou C, Rault A, Verdon E. 2010. Validation of a Five Plate Test, the STAR protocol, for the screening of antibiotic residues in muscle from different animal species according to European Decision 2002/657/EC. Food Addit Contam Part A. 27:935–952.
  • Gaudin V, Hédou C, Sanders P. 2007. Validation of a biacore method for screening eight sulfonamides in milk and porcine muscle tissues according to european decision 2002/657/EC. J AOAC Int. 90:1706–1715.
  • Gaudin V, Hedou C, Soumet C, Verdon E. 2014a. Evaluation and validation of a biochip multi-array technology for the screening of 14 sulphonamide and trimethoprim residues in honey according to the European guideline for the validation of screening methods for veterinary medicines. Food Agric Immunol. 26:477–495.
  • Gaudin V, Hedou C, Soumet C, Verdon E. 2014b. Evaluation and validation of biochip multi-array technology for the screening of six families of antibiotics in honey according to the European guideline for the validation of screening methods for residues of veterinary medicines. Food Addit Contam Part A. 31:1699–1711.
  • Gaudin V, Hedou C, Soumet C, Verdon E. 2016. Evaluation and validation of a multi-residue method based on biochip technology for the simultaneous screening of six families of antibiotics in muscle and aquaculture products. Food Addit Contam Part A. 33:403–419.
  • Gaudin V, Hedou C, Verdon E. 2013. Validation of 2 ELISA kits for the screening of tylosin and streptomycin in honey according to the European decision EC/2002/657. Food Addit Contam Part A. 30:93–109.
  • Gaudin V, Laurentie M. 2009. Application of total error approach to assess the performance of a biological method (ELISA) to detect nicarbazin residues in eggs. J Chromatogr B Method Validat Compar Transfer. 877:2358–2362.
  • Gaudin V, Maris P. 2001. Development of a biosensor based immunoassay for screening of chloramphenicol residues in milk. Food Agric Immunol. 13:77–86.
  • Gaudin V, Pavy ML. 1999. Determination of sulfamethazine in milk by biosensor immunoassay. J AOAC Int. 82:1319–1320.
  • Gaugain-Juhel M, Delépine B, Gautier S, Fourmond MP, Gaudin V, Hurtaud-Pessel D, Verdon E, Sanders P. 2009. Validation of a liquid chromatography-tandem mass spectrometry screening method to monitor 58 antibiotics in milk: a qualitative approach. Food Addit Contam Part A. 26:1459–1471.
  • Haasnoot W, Stouten P, Cazemier G, Lommen A, Nouws JF, Keukens HJ. 1999. Immunochemical detection of aminoglycosides in milk and kidney. Anal. 124:301.
  • Hennart SLA, Faragher J. 2012. Validation of the delvotest SP NT DA. J AOAC Int. 95:252–260.
  • Hubert P, Nguyen-Huu JJ, Boulanger B, Chapuzet E, Chiap P, Cohen N, Compagnon PA, Dewé W, Feinberg M, Lallier M, et al. 2007a. Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal – Part II. J Pharm Biomed Anal. 45:70–81.
  • Hubert P, NguyenHuu JJ, Boulanger B, Chapuzet E, Chiap P, Cohen N, Compagnon PA, Dewe W, Feinberg M, Lallier M, et al. 2004. Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - part I.. J Pharm Biomed Anal. 36:579–586.
  • Hubert P, Nguyen-Huu JJ, Boulanger B, Chapuzet E, Cohen N, Compagnon PA, Dewé W, Feinberg M, Laurentie M, Mercier N, et al. 2007b. Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal–Part III. J Pharm Biomed Anal. 45:82–96.
  • Hubert P, Nguyen-Huu JJ, Boulanger B, Chapuzet E, Cohen N, Compagnon PA, Dewé W, Feinberg M, Laurentie M, Mercier N, et al. 2008. Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal: Part IV. Examples of application. J Pharm Biomed Anal. 48:760–771.
  • Hubert PH, Nguyen-Huu JJ, Boulanger B. 2003. Validation des procedures analytiques quantitatives: harmonisation des demarches. STP Pharma Pratiques. 13(3):101–138.
  • ISO 11843. 1997. Capability of Detection, Part 1: Terms and Definitions Part 2: methodology in the linear calibration case.
  • ISO 11843. 2008. Capability of detection – Part 5: methodology in the linear and non-linear calibration cases.
  • ISO/IEC 17025. 2005. General requirements for the competence of testing and calibration laboratories.
  • Johansson MA, Hellenas KE. 2004. Immunobiosensor determination of beta-agonists in urine using integrated immunofiltration clean-up. Int J Food Sci Technol. 39:891–898.
  • Johnson R, Mills J, Pittet J-L, Hughes D. 2013. Comparative evaluation of the VIDAS® Listeria monocytogenes Xpress (LMX) for the detection of listeria monocytogenes in a variety of foods. J AOAC Int. 96:229–241.
  • Laurentie M, Gaudin V. 2009. Use of the total error approach to evaluate the performance of a semi-quantitative immunological method (BIACORE method) for detecting sulfamethazine in bovine milk. J Chromatogr B Method Validat Compar Transfer. 877:2375–2379.
  • Leufroy A, Noël L, Bouisset P, Maillard S, Bernagout S, Xhaard C, de Vathaire F, Guérin T. 2015. Determination of total iodine in French Polynesian foods: method validation and occurrence data. Food Chem. 169:134–140.
  • Lopes RP, Augusti DV, Oliveira AGM, Oliveira FAS, Vargas EA, Augusti R. 2011. Development and validation of a methodology to qualitatively screening veterinary drugs in porcine muscle via an innovative extraction/clean-up procedure and LC-MS/MS analysis. Food Addit Contam Part A. 28:1667–1676.
  • Mermet JM, Granier G. 2012. Potential of accuracy profile for method validation in inductively coupled plasma spectrochemistry. Spectroch Acta Part B Atom Spectrosc. 76:214–220.
  • Mompelat S, Fourmond M-P, Laurentie M, Verdon E, Hurtaud-Pessel D, Abjean J-P. 2015. Validation of a liquid chromatography–high-resolution mass spectrometry method for the analysis of ceftiofur in poultry muscle, kidneys and plasma: A unique accuracy profile for each and every matrix. J Chromatogr A. 1407:119–129.
  • Montesano D, Gennari O, Festa C, Zollo F, Seccia S, Albrizio S. 2013. A simple HPLC-DAD method for the analysis of melamine in protein supplements: validation using the accuracy profiles. J Chem. 2013:7.
  • NF EN FDIS 16140-2. 2016. Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method.
  • NF EN ISO 16140. 2003. Microbiology of the food chain — Protocol for the validation of alternative methods.
  • NF V 03-110. 2010. Analyse des produits agricoles et alimentaires - Protocole de caractérisation en vue de la validation d’une méthode d’analyse quantitative par construction du profil d’exactitude:1–57.
  • Paul V, Steinke K, Meyer HHD. 2008. Development and validation of a sensitive enzyme immunoassay for surveillance of Cry1Ab toxin in bovine blood plasma of cows fed Bt-maize (MON810). Anal Chim Acta. 607:106–113.
  • Rapport de synthèse des études préliminaire et collaborative pour le Delvotest T (DSM, Pays-Bas) dans le cadre de la marque NF Validation. 2013a. 1–77. http://nf-validation.afnor.org/wp-content/uploads/2014/03/Synt-DSM-28-02-02-12_fr.pdf.
  • Regulation (EC) No 882/2004. 2004. of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Off J Eur Union. L165:1–141.
  • Regulation (EU) 2017/625. 2017. of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products:1–142.
  • Rozet E, Wascotte V, Lecouturier N, Préat V, Dewé W, Boulanger B, Hubert P. 2007. 2007. Improvement of the decision efficiency of the accuracy profile by means of a desirability function for analytical methods validation: application to a diacetyl-monoxime colorimetric assay used for the determination of urea in transdermal iontophoretic extracts. Anal Chim Acta. 591:239–247.
  • Saint-Cyr MJ, Perrin-Guyomard A, Houée P, Vasseur MV, Laurentie M. 2014. Use of accuracy profile procedure to validate a real-time PCR method to quantify bacteria in feces. J AOAC Int. 97:573–579.
  • Salter RS, Conaway D, Markovsky R. 2008. Validation of the SL3 ß-Lactam test for screening milk in compliance with U.S. pasteurized milk ordinance: performance-tested MethodSM 040701. J AOAC Int. 91:675–683.
  • Salter RS, Douglas D, McRobbie L, Quintana J, Legg D, Schwartz J, Conaway D, McPhee C, Saul S, Markovsky R, et al. 2011. Validation of the Charm 3 SL3 β-lactam test for screening raw milk in compliance with the U.S. pasteurized milk ordinance. J AOAC Int. 94:348–357.
  • Samsonova JV, Baxter GA, Crooks SR, Small AE, Elliott CT. 2002. Determination of ivermectin in bovine liver by optical immunobiosensor. Biosens. Bioelectron.. 17:523–529.
  • SANCO/12571/19. 2013b. November 2013 - Guidance document on analytical quality control and validation procedures for pesticide residues analysis in food and feed.
  • Síglez MA, Nocea B, del Mar Pérez M, Mª García E, León L, Galera C. 2015. GlutenTox® pro test for the detection of gluten in select foods and surfaces. J AOAC Int. 98:1608–1627.
  • Thompson M, Ellison SLR, Wood R. 2002. Harmonized guidelines for single-laboratory validation of methods of analysis (iupac technical report). Pure Appl. Chem. 74:835–855.
  • Tighrine A, Amir Y, Mamou M. 2017. Application of an accuracy profile strategy based on the β-expectation tolerance interval for the validation of a liquid chromatography analytical method for the quantification of benzoic acid and its salts in different foodstuffs. J AOAC Int. 100:241–244.
  • Uhlig S, Gowik P. 2009. Factorial interlaboratory tests for microbiological measurement methods. Journal Für Verbraucherschutz Und Lebensmittelsicherheit. 5:35–46.
  • Uhlig S, Niewöhner L, Gowik P. 2011. Can the usual validation standard series for quantitative methods, ISO 5725, be also applied for qualitative methods?. Accreditat Qual Assur. 16:533–537.
  • Waldron TT. 2013. IDEXX SNAP beta-lactam ST validation for penicillin G detection. J AOAC Int. 96:1343–1349.
  • Wallace FM. 2013. DuPont BAX® system PCR assay for genus listeria 24E. J AOAC Int. 96:524–531.
  • Watanabe H, Satake A, Kido Y, Tsuji A. 2002. Monoclonal-based enzyme-linked immunosorbent assay and immunochromatographic assay for enrofloxacin in biological matrices. Anal. 127:98–103.
  • Wehling P, LaBudde RA, Brunelle SL, Nelson MT. 2011. Probability of Detection (POD) as a statistical model for the validation of qualitative methods. J AOAC Int. 94:335–347.
  • Wilrich C, Wilrich PT. 2009. Estimation of the pod function and the LOD of a qualitative microbiological measurement method. J AOAC Int. 92:1763–1772.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.