NCT01488721

Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,462 (actual)
• Sponsor: Luminex Corporation · Industry
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Adrenal Hyperplasia, Congenital
• Congenital Hypothyroidism
• Cystic Fibrosis

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-02-01
• Completion: 2012-04-01
• First posted: 2011-12-08
• Last updated: 2012-08-17

Locations

3 sites across 1 country: United States