Total Collaborative Study Protocol_Solus One Salmonella v1 1

presence of additional selective pressures from higher supplement levels could result in the generation 

of false negative results. As such, the enrichment medium used with these matrices was modified to be 

less stringent than the original (2.22 mL Solus One  Salmonella  supplement per 1.0 L medium compared 

to 4.44 mL of supplement per 1.0 L), a subset of inclusivity and exclusivity strains was also tested.  

Independent Laboratory Studies 

Inclusivity/Exclusivity Study 

This study was carried out with pure cultures to examine the ability of the Solus One  Salmonella 

method to detect a variety of claimed  Salmonella  strains and to distinguish those strains from non‐

Salmonella  strains.  

In addition, at least two serovars were selected from  Salmonella enterica  subspecies  salamae , 

Salmonella enterica  subspecies arizonae ,  Salmonella enterica  subspecies diarizonae ,  Salmonella enterica

subspecies houtenae and  Salmonella enterica  subspecies  indica . Also at least two  Salmonella bongori

strains and only one strain per serovar of  Salmonella enterica  subspecies enterica were selected. 

For the inclusivity study evaluation of Solus One  Salmonella , 59  Salmonella  strains were cultured in 9 

mL of Solus mBPW Medium supplemented with 2.22 mL Solus One  Salmonella  supplement per 1.0 L 

medium for 16–20 h at 41.5 ± 1°C. After incubation, the culture tubes were diluted with sterile Solus 

supplemented mBPW enrichment medium to 10–100x the Limit of Detection (LOD 50

) of the method, 

approximately 1 x 10 4  – 1 x 10 5  CFU/mL.  

For the exclusivity portion of the evaluation, 10 species including Gram negative bacterial species 

and Gram positive bacterial species, were cultured in 9 mL of Brain Heart Infusion (BHI) broth for 22 ± 2

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