Table 1.

Validation parameters and acceptance criteria

Validation parameter	Acceptance criterion	Remark
Specificity	Nonblocked/blocked ratio ≥ 4
Matrix effect	Effect of matrix ≤ 30%	Criteria adjusted to cell-based assay performance
Linearity	0.7 < 90% CI of slope < 1.3
Repeatability	CV ≤ 30%	Criteria adjusted to cell-based assay performance
Intermediate precision	CV ≤ 30%	Criteria adjusted to cell-based assay performance
LOQ	For information purposes only
LOD	For information purposes only
Accuracy	Difference between HRIG and CL184 ≤ 30%	Accuracy is measured as concordance between HRIG and CL184
Stability	Difference between stability sample and comparator sample ≤ 30%	Criteria adjusted to cell-based assay performance