Table 4.

Concordance between the guinea pig model and bovine for the analysis of vaccine of known potency and commercial vaccines of unknown potency.^a.

Guinea pig/Bovine	Unsatisfactory $\overline{x}$ < 1.69	Satisfactory 1.69 ≤ $\overline{x}$ < 2.72	Very satisfactory 2.72 ≤ $\overline{x}$
(a) ELISA; n = 41
Unsatisfactory $\overline{x}<1.93$	12	0	0
Satisfactory $1.93\le \overline{x}<3.02$	0	3	3
Very satisfactory $3.02\le \overline{x}$	0	2	21

Guinea pig/Bovine	Unsatisfactory $\overline{x}<1.27$	Satisfactory $1.27\le \overline{x}<1.96$	Very satisfactory $1.96\le \overline{x}$
(b) VN; n = 41
Unsatisfactory $\overline{x}<1.31$	12	0	1
Satisfactory $1.31\le \overline{x}<2.05$	2	10	1
Very satisfactory $2.05\le \overline{x}$	0	4	11

ELISA Weighted Kappa: 0.865; ASE = 0.060; 95%CI 0.748–0.982; p < 0.0001; almost perfect agreement.

VN Weighted Kappa: 0.761; ASE = 0.082; 95%CI 0.601–0.921; p < 0.0001; substantial agreement.

^aThe analysis included 12 assays including vaccines of known antigen concentration (known potency) referred and “reference vaccines” and 22 assays including commercial vaccines of unknown potency and their corresponding negative control groups (n = 7).