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Evaluation of immunoassay kits for determination of ochratoxin A in cereals3.1.3 International approval framesThe compliancy to guidelines is summarised in Table 8.Table 8: Guidelines used for performing the validationAokin Charm EuroProxima LCTech R-Biopharm RomerlabsEuropean Guidelines NS NO YES NS NO NOAOAC Guidelines: NS NO NO NS NO NOUSDA/GIPSA/FGIS NS YES NO NS NS YESOther Guidelines NS NO NO NS YES (NS) NO3.1.4 Characterisation by appropriate analytical performance criteriaFor a reliable screening analytical methods have to fulfil several critical steps of validation as presented in reference 2 ,the ones focused on in this review are summarised in Table 9. A comparison of various international guidelines foranalytical method validation can be found in ref 62 . Table 10 indicates how recovery, confidence intervals, standardcombined uncertainty and expanded uncertainty are calculated.Table 9: Brief definition of various validation parametersPerformance characteristicsActivitySpecificityRecoveryAccuracyPrecisionLinearityRangeDetection limit (LOD)Quantification limit (LOQ)Ability to measure desired analyte in a complex matrixAmount actually extractedAgreement between measured and real valueAgreement between a series of measurementsProportionality of measured value to concentrationInterval where method is precise, accurate and linearLowest amount of analyte that can be detectedLowest amount of analyte that can be quantifiedTable 10: Calculation of parametersParameterEquationRecovery Equation 1 Rec% = (xe/xt)*10095% confidence interval Equation 2 U(95%)= t0.95 (N-1) * RSD/√(N)Standard combined uncertainty Equation 3 u(comb)= √(CV 2 +u(bias) 2 )Expanded uncertainty Equation 4 U(comb)= k * u(comb)Squared root mean CV Equation 5 SQR CV = √(CV1 2 + CV2 2 )62 Chandran S, Singh RS., Pharmazie. 2007 Jan;62(1):4-14.3-16 Administrative evaluation | CODA-CERVA
Evaluation of immunoassay kits for determination of ochratoxin A in cerealsTo verify the agreement between the immunoassays and the reference values linear regression was used with Lin‟sconcordance coefficient as criterion. Table 11 gives an overview of the scales used for values of the coefficient.Table 11: Extend of agreement based on Lin’s concordance coefficient 63AgreementρcAlmost perfect >0.99Substantial 0.95-0.99Moderate 0.90-0.95Poor
Page 1: CODA-CERVAEvaluation of immunoassay
Page 5: We would like to thank the kit manu
Page 8 and 9: 4.1.4.2 Work package II: Cross reac
Page 10 and 11: Table 45: Cross-reactivity in matri
Page 13: 1. Foreword & scope &background
Page 16 and 17: Evaluation of immunoassay kits for
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Page 27: 3. Administrative evaluation
Page 37 and 38: Measured value (ng/g)Evaluation of
Page 51: 4. Experimental evaluation
Page 60 and 61: ()Evaluation of immunoassay kits fo
Page 62 and 63: Observed Concentration (ng/g)Observ
Page 79: 5. Conclusion and futureprospects

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