CompletedNot Applicable

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

United Kingdom150 participantsStarted 2017-11-17

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Subject is ≥ 18 years of age
✓. Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent.
✓. Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm

Exclusion criteria

✕. Subject is unable to give consent
✕. Subject has already participated in the study

What they're measuring

Sample handling

Timeframe: 3 months

Trial details

NCT IDNCT03629795

SponsorAxis Shield Diagnostics Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-01-24

View on ClinicalTrials.gov More Trisomy 21 in Fetus trials