Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Adrenal Hyperplasia, Congenital; Congenital Hypothyroidism; Cystic Fibrosis

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 Design

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Study Type :	Observational
Actual Enrollment :	7462 participants
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
Study Start Date :	December 2011
Actual Primary Completion Date :	February 2012
Actual Study Completion Date :	April 2012

Groups and Cohorts

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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.

Outcome Measures

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Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 7 Days (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Luminex Corporation
ClinicalTrials.gov Identifier:	NCT01488721 History of Changes
Other Study ID Numbers:	CLD-0001
First Posted:	December 8, 2011
Last Update Posted:	August 17, 2012
Last Verified:	August 2012

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