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Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

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ClinicalTrials.gov Identifier: NCT01488721
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : August 17, 2012
Information provided by (Responsible Party):
Luminex Molecular Diagnostics ( Luminex Corporation )

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 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
Primary Completion Date : February 2012
Study Completion Date : April 2012

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.

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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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488721

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
Study Director: Dennis Smith, PhD Luminex Corporation

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

Additional relevant MeSH terms:
Cystic Fibrosis
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
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
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine