Total Collaborative Study Protocol_Solus One Salmonella v1 1

Table 5: Product consistency (lot‐to‐lot) and Stability of Solus One Salmonella Method, Paired Lot POD comparison 

Lot age,  months 

Lot age,  months  N 

Lot 

N a

x b  POD A c

95% CI 

Lot 

x  POD B d

95% CI 

dPOD AB

95% CI f

e

Target analyte:  Salmonella Typhimurium NCTC 5711 NDS008 g 9  10  9  0.9 

0.60, 1.00  0.40, 0.89  0.40, 0.89  0.00, 0.28  0.00, 0.28  0.00, 0.28 

NDS009 h NDS009  NDS008 

3  3  9  3  3  9 

10  10  10  10  10  10 

7  7  9  0  0  0 

0.7  0.7  0.9  0.0  0.0  0.0 

0.40,  0.89  0.40, 0.89  0.60, 1.00  0.00,  0.28  0.00, 0.28  0.00, 0.28 

0.2  0.0 

 ‐0.16, 0.52   ‐0.36, 0.36  ‐0.52, 0.16   ‐0.28, 0.28   ‐0.28, 0.28  ‐0.28, 0.28 

NDS007 i NDS007 

16  16 

10  10 

7  7 

0.7  0.7 

‐0.2 

Non‐target analyte: Citrobacter freundii NCTC 6272 NDS008  9  10  0  0.0 

NDS009  NDS009  NDS008 

0.0  0.0  0.0 

NDS007  NDS007 

16  16 

10  10 

0  0 

0.0  0.0 

a N = Number of test portions.  b x = Number of positive test portions. .  c POD A = Positive outcomes divided by the total number of trials first member of pair.  d POD B = Positive outcomes divided by the total number of trials second member of pair.  e dPOD AB = Difference in POD between the paired comparison.   f 95% CI = If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level.  g Lot NDS008 was produced 18 September 2017‐middle of expiration period. 

h Lot NDS009 was produced 26 March 2018‐recently manufactured.  i Lot NDS007 was produced 22 February 2017‐end of expiration period.

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