Table 1 Validation of LOD and confirmatory cut point.

LOD determination—Mean and ratio
Mean DMSO responses			Confirmatory response ratios
Mean SFU/well			Response ratios: antigen vs DMSO
Donor ID (n = 18)	Triplicate mean SFU/well	Triplicate mean SFU (log ₁₀ transformed)	AAV5 pool 1/mock	AAV5 pool 2/mock	Transgene-product peptide pool/mock
1	2	0.368	1.000	0.714	0.857
2^C	1	0.000	3.000	1.333	1.667
3^D	1	0.000	0.000	1.333	2.333
4	1	0.125	1.000	0.250	1.000
5	14	1.146	1.643	1.500	0.952
6	10	1.000	1.600	1.133	1.367
7^A	71	1.851	1.164	1.192	1.169
8	5	0.699	1.067	1.067	1.000
9	3	0.523	1.700	1.700	1.000
10^B	1	0.125	2.500	3.750	4.750
11	5	0.727	0.813	1.000	1.125
12	2	0.222	1.000	1.400	1.400
13	9	0.938	1.038	0.577	1.731
14	11	1.041	1.091	0.970	0.727
15	4	0.602	0.917	1.083	1.417
16	8	0.885	1.000	0.826	1.000
17	2	0.368	0.857	0.286	1.143
18	5	0.669	0.286	0.643	0.643
Minimum		0			0
25% percentile		0.17			0.857
Median		0.60			1.000
75% percentile		0.91			1.333
Maximum		1.15			1.731
Mean		0.56			1.049
Std. deviation		0.38			0.387
LOD determination (normal distrib.)			Confirmatory cut point determination
Mean + 1.645x StDev	1.175		Mean +1.645x StDev
LOD (Anti-log of above)	15.0				1.69

Bold numbers represent the final calculated value for LOD and confirmatory cut point ratio respectively.
LOD and confirmatory cut point were based on a statistical analysis of the mean responses (SFU/well) under unstimulated (mock) conditions and the antigen/mock response ratios in naive monkeys, respectively. One result (7A (71)) was identified as a statistical outlier and excluded from the LOD analysis. Response ratios were obtained by dividing the triplicate mean SFU/well responses for AAV5 or transgene-product (TGP) peptide pools by the respective triplicate mean SFU/well response under unstimulated conditions (i.e., peptide stimulation/mock control). Five response ratios (2C (3.000), 3D (2.333) and 10B (2.500, 3.750 and 4.750)) were identified as statistical outliers and excluded from the confirmatory cut point analysis.

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