Total Collaborative Study Protocol_Solus One Salmonella v1 1

analyzed using both the manual and automated immunoassay sample preparation methods for the 

detection of  Salmonella  from cheddar cheese (shredded) and stainless steel environmental surfaces, 

whereas all method developer study samples were analyzed using the automated immunoassay sample 

preparation method. Regardless of which method was used to prepare the test portions, all samples 

were read using the Dynex DS2 instrument, using the “Plate Read Only” program for the manual 

method. 

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 closely 

related non‐ Salmonella  strains; where at least 50% of the organisms tested originated from foodborne 

isolates.  

In addition, at least four 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 , 108  Salmonella  strains were cultured in 

9 mL of Solus supplemented BPW Medium for 16–20 h at 41.5 ± 1°C. After incubation, the culture tubes 

were diluted with sterile Solus supplemented BPW 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.

Page 20 of 47