Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

NCT01488721 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7462

Last updated 2012-08-17

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01488721 on ClinicalTrials.gov