OMA Protocol Review: OMAMAN-56 Sulfites in Shrimp

Biolan Microbiosensores BIOFISH 300 SUL Collaborative Study Protocol

February 2019

The BIOFISH 300 SUL was evaluated by the AOAC Research Institute and granted PTM certification #031802. The performance of the method in 3 matrices was compared to that of OMA 990.28, Sulfites in Foods – Optimized Monier-Williams Method. The validated matrixes included raw shrimp with heads, raw headless shrimp, and cooked shrimp. The method developer studies included linearity, LOD, LOQ, accuracy, bias, recovery, precision, selectivity, lot–to-lot consistency, stability, and robustness. The matrix studies included both incurred and fortified (metabisulfite) matrices. Due to the low throughput and OMA status of the reference method, OMA 990.28 was carried out on 3 replicate test portions per concentration, while the BIOFISH 300 SUL method was carried out on 5 replicate test portions per concentration and was performed on two different days by two different analysts. Anfaco Cecopesca conducted the official analysis with the OMA method for the method developer. The independent laboratory study conducted by Eurofins Nutrition Analysis Center used raw headless shrimp fortified with metabisulfite, with 3 replicates per concentration tested by the OMA method and 5 replicates per concentration tested by the BIOFISH 300 SUL method. Performance indicators included bias, accuracy, recovery, repeatability precision, LOD and LOQ. Accuracy was assessed as (mean Biofish /mean OMA )*100 and recovery was assessed as (mean Biofish /fortification)*100. Accuracy ranged from 82 to 115% in all samples except for fortified raw shrimp with head where the low level yielded an accuracy of 138 %. The method bias was in general negative in both incurred and fortified high levels, and slightly positive in incurred low levels. Repeatability was very good as shown by the low RDSr values demonstrating acceptable repeatability precision with results less than 10 % in most cases. Regression analyses showed a good correlation between the BIOFISH and OMA methods with R 2 > 0.99 in all cases. The original PTM report and the range extension report are provided for your review along with this collaborative study protocol. 2.0 Collaborative Study The Collaborative Study will follow OMA Appendix D guidelines. 2.1 Study Director The Study Director is: Sandra Salleres Biolan Microbiosensores Tel.: +34 946 574 161 ssalleres@biolanmb.com Collaborators A minimum of 8 valid data sets are needed for the successful completion of this study, so 10-12 collaborators will be solicited to participate. All collaborators have been, or will be, trained on the BIOFISH 300 SUL method. There may be up to two collaborators per laboratory working 2.2

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