Loading clinical trials...

COMPLETED

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

NCT01488721•Luminex Corporation

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (3)

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, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

February 1, 2012

Completion Date

April 1, 2012

Last Updated

August 17, 2012

Enrollment

7,462

ACTUAL participants

Conditions

Adrenal Hyperplasia, CongenitalCongenital HypothyroidismCystic Fibrosis

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease

Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine