Validation of commercial screening tests by ILVO (current list)

ILVO validates commercial screening tests for detection of various compounds in various foodstuffs, and is also approved by AOAC as expert laboratory. In the period July 2017 - March 2021 ILVO was also an expert laboratory for AFNOR.

To validate test kits, the following parameters have to be determined:

  • detection capability
  • test selectivity/specificity
  • rate of false positive/false negative results
  • repeatability of the reader/test and robustness (impact of small changes in the test protocol; impact of the quality, composition or type of the matrix; impact of age of reagents; etc.).

Participation in (national) ring trials is also normally included in the validation.

Our main focus has been on the validation of tests for the detection of antibiotics in milk; however validation studies in other matrices (meat, honey, fish, etc.), as well as of other compounds (aflatoxins, colorants, etc.) have been performed.

Contact: Wim Reybroeck and Katrien Broekaert.

Commercial screening kits for antibiotic residues validated at ILVO (update 01 March 2021)

Short description of the validation protocol

The evaluation of test kits is performed according to Commission Decision 2002/657/EC, the CRL (Community Reference Laboratories) guidelines for the validation of screening methods for residues of veterinary medicines (Anon., 2010) in a manner consistent with the ISO guideline (ISO, 2020; in preparation). In case the study is performed in order to get AFNOR or AOAC approval, their respective validation protocols are also respected.

Commercial screening kits for mycotoxins validated at ILVO (update 01 March 2021

Short description of the validation method

The evaluation of test kits is performed according to Commission Decision 2002/657/EC, CRL Guidelines (Anon., 2010) (despite this legislation is related to the detection of veterinary drugs) and Commission Regulation (EU) No 519/2014 in order to check if the tests are suitable as a raw milk screening tests at 50 ng AFM1/L, the European Maximum Limit (ML) or at 500 ng AFM1/L, the US-FDA and Codex Alimentarius ML. Additionally, the data can be used to evaluate quantitative test parameters defined in Commission Decision 2002/657/EC. In case the study is performed in order to get AOAC approval, their respective validation protocols are also respected.

Commercial screening kits for detection of other compounds (update 01 March 2021)

Short description of the validation protocol/method

The evaluation of test kits is performed according to Commission Decision 2002/657/EC, the CRL Guidelines (Anon., 2010) (despite this legislation is related to the detection of veterinary drugs) and legislation specific for the compounds concerned. In case the study is performed in order to get AFNOR or AOAC approval, their respective validation protocols are also respected.

Validated by ILVO: what does it mean?

“Validated by ILVO” means that ILVO has performed a validation study of this test, in most cases upon request of the kit producer. Within this validation study, at least the detection capability is determined for all (or part of) the compounds given in the kit insert. In addition, other parameters could be determined such as test selectivity/specificity, rate of false positive/false negative results, repeatability of the reader/test and robustness.
Being validated by ILVO does not mean that ILVO approves or recommends this test. It is simply an independent evaluation of the test kit performed in accordance with legislation (Commission Decision 2002/657/EC, guidelines for the validation of screening methods for residues of veterinary medicines (Anon., 2010), ISO guideline (ISO, 2020; in preparation), and protocols of accreditation bodies (AFNOR, 2017; AOAC, 2018). In case the validation is performed upon request of the kit manufacturer, the report of the validation study is given to the producer of the test kit.

Kit manufacturers are allowed to use the ILVO logo or the wording “validated by ILVO” only on test kits which have been effectively validated at ILVO, on condition that the kit composition and test protocol are still exactly the same as the validated kit (version).

References

  • AFNOR. 2017. Protocole de validation des méthodes de détection et de quantification des résidus de médicaments vétérinaires dans les produits agroalimentaires. Révision No. 01. Date d’application: 1er juin 2017. AFNOR, La Plaine Saint-Denis Cedex, France: 1-65.
  • Anonymous. 2010. Guidelines for the validation of screening methods for residues of veterinary medicines (initial validation and transfer). Community Reference Laboratories Residues (CRLs). 20/01/2010: 1-18.
  • AOAC. 2018. Standard Method Performance Requirements (SMPRs®) for Screening and Identification Method for Regulated Veterinary Drug Residues in Food. AOAC INTERNATIONAL. Approved by the AOAC Stakeholder Panel on Strategic Food Analytical Methods (SPSFAM). Final Version Date: August 26, 2018.
  • Commission Decision (EC) No 2002/657 of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results. Off. J. Eur. Comm. 2002, L221: 8-36.
  • Commission Regulation (EU) No 165/2010 of 26 February 2010 amending Regulation (EC) no. 1881/2006 setting maximum levels for certain contaminants in foodstuffs as regards aflatoxins. Off. J. Eur. Union 2010, L50: 8-12.
  • Commission Regulation (EU) No 519/2014 of 16 May 2014 amending Regulation (EC) No 401/2006 as regards methods of sampling of large lots, spices and food supplements, performance criteria for T-2, HT-2 toxin and citrinin and screening methods of analysis. Off. J. Eur. Union 2014, L147: 29-43.
  • ISO. 2020. ISO 23758. Guideline for the validation of qualitative screening tests for the detection of residues of veterinary drugs in milk and milk products. Document submitted to ISO: 1-46.