Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
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ClinicalTrials.gov Identifier: NCT01488721 |
Recruitment Status
:
Completed
First Posted
: December 8, 2011
Last Update Posted
: August 17, 2012
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Condition or disease |
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Adrenal Hyperplasia, Congenital Congenital Hypothyroidism Cystic Fibrosis |
Study Type : | Observational |
Actual Enrollment : | 7462 participants |
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 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | April 2012 |

Group/Cohort |
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General Newborn Population-Prospective
Specimens prospectively collected in the course of routine newborn screening originating from hospitals, birthing centers, and/or clinics.
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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.
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Ages Eligible for Study: | up to 7 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488721
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 |
Responsible Party: | Luminex Corporation |
ClinicalTrials.gov Identifier: | NCT01488721 History of Changes |
Other Study ID Numbers: |
CLD-0001 |
First Posted: | December 8, 2011 Key Record Dates |
Last Update Posted: | August 17, 2012 |
Last Verified: | August 2012 |
Additional relevant MeSH terms:
Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Cystic Fibrosis Hyperplasia Hypothyroidism Congenital Hypothyroidism Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Thyroid Diseases |
Endocrine System Diseases Disorders of Sex Development Urogenital Abnormalities Congenital Abnormalities Steroid Metabolism, Inborn Errors Metabolism, Inborn Errors Metabolic Diseases Adrenal Gland Diseases Gonadal Disorders Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine |