Table 2. Concordance between Qualitative Results obtained using Traditional vs. the Endosafe^® test systems.

Results	Pre-Study Samples (N)	Standard Cell Therapy Samples (N)	Fabricated Positive Samples (N)	Overall Total Paired Samples by Results (N)
Endosafe® - Positive/Borderline Traditional - Positive/Borderline	0	2	18	20/139 (14.4%)
Endosafe® - Negative Traditional - Negative	30	35	30	95/139 (68.3%)
Total N of Paired Samples (% Concordance within sample types)	30/30 (100%)	37/45 (82%)	48/64 (75%)	115/139 (82.7%)

N = Number

Negative = <2.0EU/mL

Positive = >5.0 EU/mL

Borderline = >2.0 EU/mL - <5.0 EU/mL