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 Details — Status: Completed

Administrative data

• NCT number: NCT01488721
• Other study ID #: CLD-0001
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: August 16, 2012
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Luminex Molecular Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7462
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenogenital Syndrome
• Congenital Hypothyroidism
• Cystic Fibrosis
• Hyperplasia
• Hypothyroidism

Locations

Country	Name	City	State
United States	New York State Department of Health	Albany	New York
United States	Tennessee Department of Health	Nashville	Tennessee
United States	Unified State Laboratories: Public Health	Taylorsville	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Luminex Corporation

Country where clinical trial is conducted

United States,