Clinical Evaluation of NeoPlex4 Assay and 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.

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Key information

Conditions

Adrenal Hyperplasia, Congenital Adrenal Gland Diseases Adrenogenital Syndrome Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Congenital Abnormalities Congenital Hypothyroidism Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Disorders of Sex Development Dwarfism Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Hypothyroidism Infant, Newborn, Diseases Lung Diseases Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Respiratory Tract Diseases Steroid Metabolism, Inborn Errors Thyroid Diseases Urogenital Abnormalities Urogenital Diseases

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

New York State Department of Health, Albany, New York, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Luminex Corporation

Industry

Registry information

Official study title

Clinical Evaluation of the xMAP® NeoPlex4™ Assay for Detection of T4, TSH, 17-OHP and IRT Using the NeoPlex System

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Dec 8, 2011
Registry last updated: Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed