Table 1.

Parameters assessed during the validation process of the assay.

Assay Performance Parameters
Population study	3200 de-identified DBS collected >4 years ago
Limit of blank	45 DBS interspersed with 45 filter blanks
Sensitivity, Specificity, Accuracy	20 positive, 20 carriers, and 15 normal DBS
Repeatability	24 known samples run in quadruple
Intermediate Precision	Same 96 DBS samples run in 4 different runs
Reproducibility	Proficiency samples tested
Robustness	Durability of prepared mastermix tested