Status:
COMPLETED
Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
Lead Sponsor:
Luminex Corporation
Conditions:
Adrenal Hyperplasia, Congenital
Congenital Hypothyroidism
Eligibility:
All Genders
1-7 years
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 pro...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
7462 Patients enrolled
Trial Details
Trial ID
NCT01488721
Start Date
December 1 2011
End Date
April 1 2012
Last Update
August 17 2012
Active Locations (3)
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1
New York State Department of Health
Albany, New York, United States, 12201
2
Tennessee Department of Health
Nashville, Tennessee, United States, 37243
3
Unified State Laboratories: Public Health
Taylorsville, Utah, United States, 84129