Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays
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|ClinicalTrials.gov Identifier: NCT03629795|
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
|Condition or disease|
|Trisomy 21 in Fetus Trisomy 18 in Fetus Trisomy 13 in Fetus|
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 Type :||Observational|
|Actual Enrollment :||150 participants|
|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|
|Actual Study Start Date :||November 17, 2017|
|Actual Primary Completion Date :||January 24, 2018|
|Actual Study Completion Date :||January 24, 2018|
- Sample handling [ Time Frame: 3 months ]Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.
Biospecimen Retention: Samples Without DNA
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): NCT03629795
|Newcastle Upon Tyne, UK, United Kingdom, NE24HH|
|Principal Investigator:||Stephen Robson||Professor of Fetal Medicine|