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Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

Cystic Fibrosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The proposed (investigational) NeoPlex4 assay measures levels of thyroxine (T4), thyrotropin (hTSH), 17-alpha-OH-progesterone (17-OHP) and immunoreactive trypsinogen (IRT) from dried blood specimens (DBS) collected from neonates to screen for congenital hypothyroidism (CH), congenital adrenal hyperplasia (CAH) and cystic fibrosis (CF). The Clinical Evaluation of the xMAP® NeoPlex4™ Assay (NeoPlex4) for Detection of T4, TSH, 17-OHP and IRT using the NeoPlex System is a multi-center method concordance study on a combination of prospectively collected neonatal dried blood spots and pre-selected archived frozen dried blood spots that have been demonstrated to be positive for 17-OHP (CAH), IRT (CF), and T4 or TSH (CH). The study will be conducted at selected sites that routinely perform newborn screening testing in the United States. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01488721
Study type Observational
Source Luminex Molecular Diagnostics
Contact
Status Completed
Phase N/A
Start date December 2011
Completion date April 2012
View Details
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