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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 7462

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

• Sponsor: Luminex Corporation
• Investigators: Study Director: Dennis Smith, PhD, Luminex Corporation

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 7, 2011
• First Posted (ESTIMATE): December 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2012
• Last Update Submitted That Met QC Criteria: August 16, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Respiratory Tract Diseases; Lung Diseases; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Thyroid Diseases; Bone Diseases; Metabolism, Inborn Errors; Pancreatic Diseases; Bone Diseases, Endocrine; Dwarfism; Bone Diseases, Developmental; Adrenal Gland Diseases; Steroid Metabolism, Inborn Errors; Hypothyroidism; Hyperplasia; Cystic Fibrosis; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Congenital Hypothyroidism
• Other Study ID Numbers: CLD-0001