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Evaluation of immunoassay kits for determination of ochratoxin A in cereals1.2 Scope1.2.1 Objective and strategy of the inventory taskAt the present moment immunoassay kits are available in three different formats; FPIA (fluorescence polarizationimmunoassay), ELISA (enzyme-linked immunosorbent assay) and LFD (lateral flow devices). Commercialized byseveral providers they are available for all legally regulated mycotoxins.The inventory of fast test kits attempted toIdentify all the existing kit providers active on the Belgian marketIdentify the available kits for OTA determination in cereal and cereal productsEstablish collaboration with the identified kit providersThe inventory was based on the list of rapid mycotoxin testing kits available at the website “mycotoxins.org” of theEuropean Mycotoxins Awareness Network (EMAN) project. Since the last version of the EMAN website wasupdated in 2003, the inventory was completed using the individual websites of the kit providers and personal contact(telephone calls, mailings, meetings with kit producers or distributors).1.2.2 Objective and strategy of the administrative evaluationInformation was gathered on the available OTA kits from manufacturers through two questionnaires, one forquantitative and one for qualitative OTA kits. These were developed in close cooperation with the aforementionedexpert group and were addressed by mailing to the kit manufacturers. Table 1 summarizes the most commonparameters checked for quantitative or qualitative OTA kits.Table 1: Parameters for quantitative and qualitative kits 2Quantitative kitsDetection limitRange and linearitySensitivity and specificityMeasurement UncertaintyAccuracy: trueness, precisionSelectivity: interferencesRuggedness or robustnessFormats and cost per kitQuantity of materials and reagents neededProtocol, throughput and time required for performing analysisScientific supports and quality assurance in manufacturingEasy-to-use’ information according to the manufacturersQualitative kitsCut-off limitdichotomic valueFalse positive and false negative ratesUnreliability regionSensitivity and specificitySelectivity: interferencesRuggedness or robustnessFormats and cost per kitQuantity of materials and reagents neededProtocol, throughput and time required for performing analysisScientific supports and quality assurance in manufacturingEasy-to-use’ information according to the manufacturersNote: for a quantitative method, sensitivity should be a numerical value that indicates how the response changes whenever there is a variation inthe concentration of the analyte. However, this parameter will be evaluated in a different way if a qualitative method is used.For quantitative kits, the information was checked against the Association of Official Analytical Chemists (AOAC)requirements, the Grain Inspection, Packers and Stockyards Administration (GIPSA) of the United StatesDepartment of Agriculture (USDA/GIPSA/FGIS) directives and the EU legislation.Regulation 1881/2006/EC 3 (as amended by both Regulations 1126/2007/EC 4 and 105/2010/EU 5 )lays downmaximal limits for certain contaminants – including ochratoxin A – in specified foods, and as such determines the2 E. Trullols Trends in Anal. Chem. 23, 2004, 1371-2 Foreword & scope & background | CODA-CERVA
Evaluation of immunoassay kits for ochratoxin A determination in cerealsrequirements with respect sensitivity of the analytical methods. Furthermore, Regulation 401/2006EC 10 (as amendedby Regulation 178/2010/EU 6 ) lays down methods for sampling and analysis, thereby defining some methodperformance criteria (i.e. minimum recovery rate, maximum reproducibility, restrictions with respect to the expandedanalytical uncertainty). The European Food Safety Authority (EFSA) has adopted an opinion on ochratoxin A infood on April 4 th 2006 7 and June 4 th 2010 8 . The Commission is currently considering the need to introducemaximum limits for ochratoxin A in other foods not currently included in the legislation. As for qualitative kits, theywere checked against the AOAC requirements and the USDA/GIPSA/FGIS directives 9181.2 9 as well as Regulation401/2006/EC 10 . Note that CEN-CR 13505:1999 11 and Decision 2002/657/EC 12 indicate the parameters that arerelevant for screening and confirmation methods. Decision 2002/657/EC 12 states that screening methods should bevalidated and that the 'false compliant rate (false negatives) should be
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5. Conclusion and futureprospects
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