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. 2018 Nov;56:29–38. doi: 10.1016/j.biologicals.2018.09.001

Table 6.

Potency estimates for U.S. reference reagent Vi-IgGR1, 2011, the coded duplicate of 16/138 and 10/126 relative to 16/138.

Method Lab code Sample C (16/138) Vi-IgGR1, 2011 Sample A (10/126)
VaccZyme ELISA
1 0.70 1.60 0.84
2 0.97 2.02 1.04
3 1.01 1.60 1.18
4 1.08 1.59 1.09
5 0.94 1.39 1.23
6
1.22
1.63
1.21
In-house ELISA
1 1.04 1.88 0.93
4 1.01 1.89 1.17
5
0.90
1.70
1.09
GMa by VaccZyme ELISA (95% CIb) 1.63 (1.44–1.85) 1.09 (0.94–1.27)
GM by all ELISAs (95% CI) 1.69 (1.55–1.85) 1.08 (0.98–1.19)
GM by VaccZyme ELISA based on potency relative to both 16/138 and sample C (95% CI) 1.65 (1.41–1.92) 1.10 (1.01–1.21)
GM by all ELISAs based on potency relative to both 16/138 and sample C (95% CI) 1.71 (1.55–1.89) 1.09 (1.01–1.18)
a

Geometric Mean.

b

Confidence Interval.