Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
Completed
Conditions studied: Adrenal Hyperplasia, Congenital, Congenital Hypothyroidism, Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT01488721
- Run by
- Luminex Corporation
- People needed
- 7462
- Starts
- 2011-12-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2012-08-17
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- New York State Department of Health — Albany, New York, United States
- Tennessee Department of Health — Nashville, Tennessee, United States
- Unified State Laboratories: Public Health — Taylorsville, Utah, United States
Full record on ClinicalTrials.gov
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