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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01488721

Enrollment

7462

Registered

2011-12-08

Start date

2011-12-31

Completion date

2012-04-30

Last updated

2012-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Hyperplasia, Congenital, Congenital Hypothyroidism, Cystic Fibrosis

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.

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 (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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 7 Days

Healthy volunteers

Yes

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.

Countries

United States

Outcome results