Clinical Evaluation of NeoPlex4 Assay and NeoPlex System - Full Text View

Purpose

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.

Condition
Adrenal Hyperplasia, Congenital Congenital Hypothyroidism Cystic Fibrosis


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Clinical Evaluation of the xMAP® NeoPlex4™ Assay for Detection of T4, TSH, 17-OHP and IRT Using the NeoPlex System

Resource links provided by NLM:

Genetics Home Reference related topics: 17 alpha-hydroxylase/17,20-lyase deficiency 21-hydroxylase deficiency 3-beta-hydroxysteroid dehydrogenase deficiency Meier-Gorlin syndrome congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency congenital hypothyroidism cystic fibrosis metatropic dysplasia persistent Müllerian duct syndrome pseudoachondroplasia

MedlinePlus related topics: Hypothyroidism

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis 21-hydroxylase Deficiency Congenital Adrenal Hyperplasia Congenital Hypothyroidism

U.S. FDA Resources

Further study details as provided by Luminex Molecular Diagnostics:


Enrollment:	7462
Study Start Date:	December 2011
Study Completion Date:	April 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
General Newborn Population-Prospective Specimens prospectively collected in the course of routine newborn screening originating from hospitals, birthing centers, and/or clinics.
Newborn Specimens-Confirmed Positive Banked confirmed positive specimens that were originally collected as part of the newborn screening program, but when found to screen positive for a disease, were followed up clinically to definitively diagnose the subject with the disease (CF, CAH or CH). Follow up results were reported to the sites by the treating clinicians.

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.

Eligibility


Ages Eligible for Study:	up to 7 Days (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Specimens will be derived from prospectively collected neonatal specimens and banked neonatal specimens originating from hospitals, birthing centers, and/or clinics. Newborn screening is currently performed on all neonates; there is no selection criterion for subjects.

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488721

Locations


United States, New York
New York State Department of Health
Albany, New York, United States, 12201
United States, Tennessee
Tennessee Department of Health
Nashville, Tennessee, United States, 37243
United States, Utah
Unified State Laboratories: Public Health
Taylorsville, Utah, United States, 84129

Sponsors and Collaborators

Luminex Corporation

Investigators


Study Director:	Dennis Smith, PhD	Luminex Corporation

More Information


Responsible Party:	Luminex Corporation
ClinicalTrials.gov Identifier:	NCT01488721 History of Changes
Other Study ID Numbers:	CLD-0001
Study First Received:	December 6, 2011
Last Updated:	August 16, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Cystic Fibrosis Hyperplasia Hypothyroidism Congenital Hypothyroidism Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Thyroid Diseases	Endocrine System Diseases Disorders of Sex Development Urogenital Abnormalities Congenital Abnormalities Steroid Metabolism, Inborn Errors Metabolism, Inborn Errors Metabolic Diseases Adrenal Gland Diseases Gonadal Disorders Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine

ClinicalTrials.gov processed this record on September 27, 2016