TABLE II

Paired T-Tests of Non-Inferiority of the ScanRDI® and Compendial Sterility Test

Organism	Difference between Mean MPN^a	Standard Deviation	n	z_n	P	Lower Confidence Limit^b
Clostridium sporogenes	0.05	0.29	24	3.518	0.0009	−0.050
Propionibacterium acnes	0.58	0.40	15	7.128	<0.0001	0.398
Escherichia coli	0.20	0.30	25	5.812	<0.0001	0.092
Pseudomonas aeruginosa	0.95	0.37	13	10.972	<0.0001	0.762
Staphylococcus aureus	0.39	0.29	14	7.067	<0.0001	0.251
Bacillus subtilis	0.43	0.23	12	8.904	<0.0001	0.308
Aspergillus niger	0.67	0.41	16	8.115	<0.0001	0.490
Candida albicans	0.64	0.46	13	6.278	<0.0001	0.412

↵a Mean log₁₀ MPN for ScanRDI® minus mean log₁₀ MPN for compendial sterility method.
↵b The acceptance criteria were satisfied if the lower one-sided 95.25% confidence limit on the paired difference was less than −0.1549, which is log₁₀(0.70).