Document - FAVV

Evaluation of immunoassay kits for determination of ochratoxin A in cereals3.1 Quantitative kits3.1.1 Overview of the kitsTable 6 gives an overview of the 6 quantitative kits involved in the administrative evaluation.Table 6: Parameters for quantitative kitsManufacturer Kit Formats Matrices Use Range Approval Confidentiality ReferencesAokin AGCharmSciencesEuropeEuroProximaBVLCTechGmbHR-BiopharmAGRomerlabsDivisionHoldingGmbHAokinmycontrolOTAROSAOCHRATOXIN GRAINOCHRATOXIN-A ELISAKinetic FPIALFDCompetitiveELISAFor commonmatricesWheat, Barley,Malted Barley, Corn,Oats, Rice,Sorghum, Soybean,WineCereals, feed,Coffee, wineLabField/LabLabOtaREAD LFD Coffee, wine Field/LabRIDASCREEN® OchratoxinA 30/15AgraQuant®OchratoxinELISA Test KitCompetitiveELISACompetitiveELISA0.1-100 ng/g0-100 ng/g1.25-40 ng/g0.6 ng/ml(beer) to20 ng/g(coffee)Cereals and feed Lab 1-36 ng/gCorn, milo, barley,green coffee, wheat,soybeans, Cereal,raisin, cocoa,birdseeds, beerISO/IEC9000/9001(Tüf Reinland)Certificate ofConformancefrom USDA-GIPSAFGIS 2008-104ISO/IEC9000/9001Bureau VeritasCertificationBVNSNSEuroProxima BVNSUS Patent5.985.6756.475.805B1NSNS LCTech GmbH NSISO/IEC9000/9001,(DQS GmbH,Frankfurt)Lab 2-40 ng/g NSNSAgraQuant®Ochratoxin Test kitis proprietary ofRomerlabsNSZheng et al.. (2005)Mycopathologia.159:2, 265-2723.1.2 Quality assuranceInformation on the quality control systems established by the manufacturers is presented in Table 7.Table 7: Quality assuranceManufacturerQuality controlIntensity ofresponseDetectability Specificity. Sensibility HomogeneityAokin AG Internal YES YES YES YES YESCharm SciencesEuropeInternal YES YES NO NR YESEuroProxima BVInternal/external(FAPAS)YES YES YES YES YESLCTech GmbH Internal YES YES NS YES YESR-Biopharm AG Internal YES YES YES YES YESRomerlabs DivisionInternal/external(FAPAS)YES YES YES YES NOCODA-CERVA | Administrative evaluation 3-15