Total Collaborative Study Protocol_Solus One Salmonella v1 1

Each level of each matrix will be analyzed and reported separately. Data may be excluded due to an  1  assignable cause, provided there is sufficient justification. Such data will not be included in the statistical  2  analysis. All data, even if excluded from the statistical analysis, will be reported (see Appendix X‐B of the  3  AOAC Guidelines for raw data table format).    6  7  The statistical analysis will be performed in accordance with the AOAC Guidelines ( Appendix X‐F ) using  8  the Least Cost Formulations, Ltd., AOAC Binary Data Interlaboratory Study Workbook (5).    9  10  7.1 Estimate the repeatability standard deviation (s r ).  11  7.2 Estimate the reproducibility (s R ) by calculating the standard deviation of the laboratory  12  POD values (s POD ) and associated 95% confidence intervals.  13  7.3 Estimate the difference of cross‐laboratory POD (dLPOD) and associated 95% confidence  14  intervals. If the confidence interval of a dLPOD does not contain a zero, then the  15  difference is statistically significant.  16  7.3.1 dLPODc is the difference between the candidate and reference LPOD values.  17  7.3.2 dLPOD is the difference between the presumptive and confirmed LPOD values.  18  7.4 Graph POD R , LPOD C and dLPOD C by level with 95% confidence intervals. 19  7.5 Calculate false positive and false negative rates. 22  23  Solus One  Salmonella  for Detection of  Salmonella  in Selected Foods and Environmental Surfaces  24  25  (Applicable to the detection of  Salmonella  in raw beef trim (375 g), non‐fat dry milk powder (NFDM, 375  26  g), pasteurized liquid egg (100 g), raw salmon (25 g), cheddar cheese (25 g), Romaine lettuce (25 g),  27  whole black peppercorns, paprika powder and cinnamon powder (25 g sample size) plus honey mustard  28  onion seasoning and flavored ranch seasoning (375 g sample size) and stainless steel and polystyrene  29  surfaces)  32  Solus One Salmonella Method .— ( a )  Ensure that the heating block reaches a temperature of 85–100°C  33  and the sample is heated for 15–20 min thus ensuring the organisms are killed and the sample is safe to  34  handle.  35  ( b ) The Stop Solution contains sulfuric acid which is corrosive. Wash immediately with large  36  quantities of water if the solution comes into contact with skin or mucous membranes.  37  ( c )  All other Solus One  Salmonella  kit components are non‐hazardous. However, product usage  38  should follow good laboratory practices and all disposable materials must be discarded according to  39  appropriate waste procedures used in the laboratory.  40  ( d ) Protective clothing should be worn including laboratory coat, safety glasses, mask, and gloves  41  where appropriate. Avoid contact with the skin. 42 4  5  7.0 Statistical Analysis  20  21  8.0 Solus One  Salmonella – Method  30  31  Caution: 

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