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.
Adrenal Hyperplasia, Congenital
|Study Design:||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|
|Study Completion Date:||April 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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.
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.
|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|
|Study Director:||Dennis Smith, PhD||Luminex Corporation|