Document - FAVV

Evaluation of immunoassay kits for determination of ochratoxin A in cerealsTable 20: Summary of the ordinary linear regression for R-BiopharmCoefficientsSlope 1.119Intercept -0.580R 2 0.958ρc 0.969T-Test 0.8803.1.4.5.2.2.3 ConclusionAn overall good agreement is seen between results obtained by R-Biopharm and the reference value. OTA immunoassa-OTA reference is not statistically dependant on OTA levels.3.1.4.6 Intra-run repeatability, inter-run repeatability and reproducibilityAccording to directive 401/2006 ref10 the relative standard deviation, calculated from results generated underrepeatability conditions should be ≤ 20% (1-10 ng/g), relative standard deviation calculated from results generatedunder reproducibility conditions should be ≤ 30% (1-10 ng/g).3.1.4.6.1 Intra-run repeatability (same batch/operator)The extended measurement uncertainty is in general well below 40%, (Table 21) indicating results are reproducible.For the Charm kit it can be seen that results vary significantly at low concentration, at high concentration the kitgenerates very reproducible results.CODA-CERVA | Administrative evaluation 3-25