Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
Clinical Evaluation of the xMAP® NeoPlex4™ Assay for Detection of T4, TSH, 17-OHP and IRT Using the NeoPlex System
1 other identifier
observational
7,462
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2011
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedAugust 17, 2012
August 1, 2012
2 months
December 6, 2011
August 16, 2012
Conditions
Study Arms (2)
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.
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
New York State Department of Health
Albany, New York, 12201, United States
Tennessee Department of Health
Nashville, Tennessee, 37243, United States
Unified State Laboratories: Public Health
Taylorsville, Utah, 84129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dennis Smith, PhD
Luminex Corporation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2011
First Posted
December 8, 2011
Study Start
December 1, 2011
Primary Completion
February 1, 2012
Study Completion
April 1, 2012
Last Updated
August 17, 2012
Record last verified: 2012-08