Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
NCT01488721 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7462
Last updated 2012-08-17
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.
Conditions
- Adrenal Hyperplasia, Congenital
- Congenital Hypothyroidism
- Cystic Fibrosis
Sponsors & Collaborators
-
Luminex Corporation
lead INDUSTRY
Principal Investigators
-
Dennis Smith, PhD · Luminex Corporation
Eligibility
- Min Age
- 1 Day
- Max Age
- 7 Days
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-12-31
- Primary Completion
- 2012-02-29
- Completion
- 2012-04-30
Countries
- United States
Study Locations
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