Table 2.

System suitability criteria and acceptance criteria for proposed cell based ELISA assay.

Parameter	Assessment	Output	%RSD
Accuracy	% Relative Bias (Should be ≤ 15%)	% Relative Bias = 8.68%	0.558%
Intermediate Precision	Variance Component Analysis ≤ 20%	%GCV = 2.66%	0.558%
Repeatability	Variance Component Analysis ≤ 20%	%GCV = 3.386	0.705%
Specificity	No Matrix interference and no dose response curve observe from media control, cell control and nonspecific monoclonal antibodies	Complies	NA