Total Collaborative Study Protocol_Solus One Salmonella v1 1
DS2 instrument is unavailable. For control assay acceptance criteria, a result of an OD 450
< 0.100 is valid
> 0.500 is valid for a Positive Control. A result of an
for a Negative Control, whereas a result of an OD 450
OD 450 < 0.200 is considered to be negative for Salmonella . A result of an OD 450
≥ 0.200 is considered
presumptive positive for Salmonella .
Confirmation
All samples are confirmed according to the appropriate reference methods specified for the matrix
and analyte.
Validation Study
This validation study was conducted under the AOAC Research Institute Performance Tested
Method SM protocol and the AOAC INTERNATIONAL Methods Committee Guidelines for Validation of
Microbiological Methods for Food and Environmental Surfaces (3). Method developer studies were
conducted in the laboratories of Solus Scientific Solutions, located in East Kilbride, Scotland, and
included the product consistency and stability studies, and robustness testing. The independent
laboratory study was conducted by Q Laboratories, located in Cincinnati, Ohio, and included the
inclusivity/exclusivity study, and matrix studies for all claimed food and environmental surface matrixes.
The Solus One Salmonella method was compared to the FDA/BAM Chapter 5 for raw salmon (fillet),
cheddar cheese (shredded), Romaine lettuce (bagged), non‐fat dry milk powder and both stainless steel
and plastic environmental surfaces. In addition, the Solus One Salmonella method was compared to the
MLG 4.09 for raw beef (trim) and pasteurized eggs. Independent laboratory study samples were
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