Total Collaborative Study Protocol_Solus One Salmonella v1 1

Matrix study 

Each food matrix claimed in this study was purchased from a local distributor, pre‐screened for 

natural contamination of the target analyte by the appropriate reference method, and analyzed for total 

aerobic count by the FDA/BAM Chapter 3 (January 2001) Aerobic Plate Count  (7). None of the selected 

food matrices were naturally contaminated with target analyte and aerobic plate counts of matrices 

highlighted in Tables 3 and 4 ranged between 1.2 x 10 5  (cinnamon powder) – 4.2 x 10 6  (flavored ranch 

seasoning) CFU/g. 

This study evaluated thirty un‐paired sample replicates for the five food matrices. Within each food 

matrix, assessment comprised of five replicate test portions un‐inoculated (0 CFU/test portion), twenty 

replicate test portions at a low inoculation level to yield fractionally positive results (0.2–2 CFU/test 

portion), and five replicate test portions at a high inoculation level to yield consistently positive results 

(2‐10 CFU/test area). A different strain of  Salmonella  species was used for the inoculation of the various 

food matrices. 

Data demonstrating fractionally positive results for each matrix tested; identified as those in which 

at least one of the candidate or reference methods yielded 5–15 positive results out of 20 replicates 

examined for the low inoculation level were required. However, results in which the candidate method 

was above the fractional range, but the reference method was below the fractional range were also 

considered acceptable. 

For the matrix study evaluation of the candidate Solus One  Salmonella method, a  Salmonella

Senftenberg QL 11031.2 (for flavored ranch seasoning matrix), a  Salmonella Typhimurium ATCC 14028 – 

origin: chicken heart and liver tissues (for honey mustard onion seasoning matrix), a  Salmonella

Mbandaka QL 11031.1 (for cinnamon powder matrix), a  Salmonella Tennessee QL 11031.3 (for paprika

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