Total Collaborative Study Protocol_Solus One Salmonella v1 1

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1. 40.4 Confirm a minimum of one typical colony per test portion with 

biochemical/serological procedures prescribed by the FDA/BAM. Either the  API20E ( Official Method 978.24 ), VITEK GN ( Official Method 2011.17 ) or Bruker  MALDI (OMA 2017.09 ), depending on availability, will be used as an alternative  to the conventional biochemical tests. The somatic (O) and flagellar (H) tests will 

also be performed. 

2.

FDA BAM Ch. 5 

2.1  For each 25 g test portion, aseptically add into sterile beaker (250 ml) or other  appropriate container. Using sterile glass or paper funnel (made with tape to withstand  autoclaving), pour 25 g analytical unit gently and slowly over surface of 225 mL brilliant  green water contained in sterile 500 mL Erlenmeyer flask or other appropriate  container. Prepare brilliant green water by adding 2 mL 1% brilliant green dye solution  per 1000 mL sterile distilled water. Let container stand undisturbed for 60 ± 5 min.  Incubate loosely capped container, without mixing or pH adjustment, for 24 ± 2 h at  2.2  Transfer 0.1 ml to 10 ml Rappaport‐Vassiliadis (RV) broth (prepared from individual  ingredients) and 1 mL to 10 mL TT broth. Pay special attention to the preparation of RV  and TT broths as USDA and FDA methods call for different formulations.  Incubate the  RV at 42  0.2°C for 24  2 h in a circulating water bath.  Incubate the TT broth at 35 ±  35°C . 

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2.0  C for 24  2 h. 

2.3  Mix and streak 3 mm loopful (10  L) RV broth onto BS, XLD and HE agars. Repeat from  TT broth. Incubate at 35  C for 24  2 h. Follow isolation procedure according to FDA 

BAM. 

2.4 

Transfer typical colonies to TSI and LIA.  Incubate at 35  C for 24  2hr.  Confirm 1 typical colony per test portion with biochemical/serological   procedures prescribed by the FDA‐BAM method.  Either the API20E ( Official Method 978.24 ), VITEK GN ( Official Method 2011.17 ) or Bruker MALDI (OMA 2017.09 ),  depending on availability, will be used as an alternative to the conventional biochemical 

tests.  The somatic (O) and flagellar (H) tests will also be performed. 

Reporting Raw Data

1.    All results are to be recorded on the data sheets provided. For each test portion, record the  34  results reported by the Solus One Salmonella along with the confirmation results for both the  35  Solus One  Salmonella and reference method.    36  2.    Report data on data report form labeled “ Solus One  Salmonella Collaborative Study Test  37  Portion Data Report Form”  for all test portions.  38  3.    Upon completion of analysis, email the completed data form result sheets to Ben Bastin at  39  BBastin@QLaboratories.com 40  41

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