Clinical Trial: Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

Study Status: Completed
Recruit Status: Completed
Study Type: Observational




Official Title: Clinical Evaluation of the xMAP® NeoPlex4™ Assay for Detection of T4, TSH, 17-OHP and IRT Using the NeoPlex System

Brief Summary: The purpose of this study is to assess the agreement of clinical performance between the proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in newborn screening programs for detection of T4, TSH, 17-OHP and IRT.