Table 4.

Summary of parameters used to validate the performance and suitability of the ELISA assay

	Parameter	Result
1	Reproducibility.	1.18 ± 0.83% of samples had discordant outcomes a
2	Sensitivity.	87 ± 3.0% a
3	Specificity.	100% a
4	Uncertainty.	Intra and interassay % CVs of 8.08 ± 7.23 and 14.57 ± 6.99, respectively a
5	Limits of detection.	20.41 pg/ml equivalent of positive control antibody with 95% confidence interval [17.67, 24.65] b
6	Dilution linearity.	Linear relationship between log positive control antibody concentration and log absorbance b

^a Mean ± standard deviation of five runs with 40 samples per run.

^b From six independent standard curves of positive control antibody from 0.8 to 200 ng/ml.