Total Collaborative Study Protocol_Solus One Salmonella v1 1
Conclusion
The data from the study, with the statistical uncertainty, support the product claims of Solus One
Salmonella for both the manual and automated sample preparation methods, using the Dynex DS2
instrument, and manual reading on the spice and flavor blend matrices analyzed.
The results obtained by the POD analysis of the method study demonstrated that there were no
statistically significant differences between the number of positive samples detected by the candidate
and the reference methods for all spice and flavor blend matrices analyzed.
References
(1) U. S. Food and Drug Administration Bacteriological Analytical Manual Chapter 5: Salmonella.
Revised: July 2018 (Accessed June 2019)
https://www.fda.gov/food/foodscienceresearch/laboratorymethods/ucm070149.htm
(2) Official Methods of Analysis (2019), 21st Edition, Appendix J, AOAC INTERNATIONAL, Rockville,
MD, http://www.eoma.aoac.org/app_j (Accessed June 2019)
(3) Solus One Salmonella ELISA Package Insert: Immunoassay Based Test System for the Detection
of Salmonella in Foods and Environmental Samples (Version 1, August 2018)
(4) Hammack, Thomas. Salmonella species. Bad Bug Book – Handbook of Foodborne Pathogenic
Microorganisms and Natural Toxins, 2 nd Ed. 2012. (Accessed June 2019)
https://www.fda.gov/food/foodborne‐pathogens/bad‐bug‐book‐second‐edition
Page 38 of 39
Made with FlippingBook - Online Brochure Maker