Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

Completed

• Conditions: Adrenal Hyperplasia, Congenital; Congenital Hypothyroidism; Cystic Fibrosis

• Registration Number: NCT01488721
• Lead Sponsor: Luminex Corporation

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.

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-08
• Primary Completion: 2012-02
• Study Completion: 2012-04
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7462

Inclusion Criteria

• The dried blood spot specimen was collected on an FDA-cleared collection paper that has not yet passed its expiration dating.
• Prospective specimens used in this study should only be those collected for the first time from a subject, or initial collection specimens.

Exclusion Criteria

• Collected within 24 hours of birth.
• Specimens stored at ambient temperature for greater than 14 days prior to testing.
• The specimen DBS appears diluted.
• The specimen DBS shows evidence of clotting, caking, layering or serum rings.
• The DBS punched disks were punched too close to the edge of the blood spot or show printed markings.
• The specimen or collection card was contaminated with fecal material.
• Non-eluting blood spot due to deterioration of sample caused by exposure to heat and humidity.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Unified State Laboratories: Public Health; 🇺🇸 Taylorsville, Utah, United States

New York State Department of Health; 🇺🇸 Albany, New York, United States

Tennessee Department of Health; 🇺🇸 Nashville, Tennessee, United States