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Exchange ofthimerosal

Page 10

with the mean CV of control samples from a reference Gliadin competitive lot. Several

measurements of similar control samples over the shelf life of this Gliadin competitive lot were used

lot calculate the mean CV of all these measurements for all control samples. The calculated mean CV

was 20.8% (the original data for this reference lot are shown in table 5 in annex section 7.4.2). The

collaborative study for AOAC OMA 2015.05 with the Gliadin competitive had a mean CV of 31.2%

(mean CV of all samples of the collaborative study with a mean concentration above the limit of

quantitation of the Gliadin competitive). The mean CV of the tested Gliadin competitive lot lay with

28.2% between the in house data of the reference Gliadin competitive lot and the mean CV of the

collaborative study. It wasthus considered not to be unusually high and the obtained concentrations

for the substitution of thimerosal with bronidox L were considered to be of value for discussion.

3.4.3

Discussion

In consequence of the higher measurement uncertainty as mentioned in the previous section, the

calculated mean concentrations were less similar to each other than it was observed for the other

three ELISA (see tables2, 4, 6 and 8). Nevertheless, no systematic difference in the concentrations for

the control samples in regard to the used washing buffer could be observed. This demonstrates that

the change of washing buffer does not have a significant influence on the concentrations of the

control samples and thus on the functionality of the test, nor on the stability of the washing buffer.