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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