Document - FAVV

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