Total Collaborative Study Protocol_Solus One Salmonella v1 1

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Table 1. Matrix Preparation 

Test  Portions/  Method 

Test  Portion  Codes  Random  number  100‐800 

Inoculation  Organism 

Reference  Method  FDA BAM  Ch. 5  

Matrix 

Target Levels   0 CFU/test portion 

12  12  12 

S. Senftenberg  ATCC TBD

NFDM 

0.2–2 CFU/ test portion  5–10 CFU/ test portion 

3  4 

4.0 5  6  To prepare artificially contaminated matrix, primary test materials will be inoculated with  Salmonella  so  7  that on the day of initiation of analysis  there is a low level (approx. 0.2–2 CFU/test portion) and a high  8  level (approximately 5–10 CFU/test portion). Note that one level of contamination must result in  9  fractional positive results. One test material will remain uninoculated to serve as the uncontaminated  10  control. The organizing laboratory will prepare and ship the test materials. Each sample will be divided  11  into test portions, randomized, and blind‐coded for analysis. Collaborators will complete and return the  12  data sheets to the study director following confirmation, within 2 weeks of the test initiation date.    Test Material Preparation and Distribution  4.1 NFDM will be obtained from a local retail outlet and screened for the presence of  Salmonella . Naturally contaminated test portions will be used if available at sufficient  levels. Alternatively, the test portions will be artificially contaminated to meet the  4.2 To artificially contaminate NFDM, a dried (lyophilized) inoculum will be used. The  inoculum will be added to a bulk test material and mixed by mechanical stirring or  rolling to achieve equal distribution of analyte throughout. Inoculated products will be  appropriate target levels.  

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stabilized for a minimum of 2 weeks at room temperature. 

4.3 The 375 g test portions for the Solus One  Salmonella method will be prepared by mixing  25 g of artificially contaminated material with 350 g of uncontaminated material for 

each contamination level. 

4.4

Test portions will be packaged in leak‐proof, insulated containers and shipped  (according to the Dangerous Goods Regulations IATA for Infectious Substances) by  overnight carrier to arrive the day before initiation of analysis . All test portions will be  shipped at ambient temperature (20–25°C). A temperature probe will be included with  each shipment to verify temperature of material upon receipt. Upon arrival, the test  portions will be stored at 20–25  C until they are analyzed. All participating collaborators 

will begin processing and analysis on the following Monday. 

Analysis and Confirmation 

5.0

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