Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays

Trisomy 21 in Fetus Clinical Trial

Official title:
Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA CENTAUR® PREGNANCY ASSOCIATED PLASMA PROTEIN A and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin ASSAYS

Status Completed

Clinical Trial Summary

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Clinical Trial Description

Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03629795
Study type	Observational
Source	Axis Shield Diagnostics Ltd
Contact
Status	Completed
Phase
Start date	November 17, 2017
Completion date	January 24, 2018

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