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

Axis Shield Diagnostics

Status: Completed

Conditions: Trisomy 21 in Fetus; Trisomy 13 in Fetus; Trisomy 18 in Fetus

Study type: Observational

Funder types: Industry

Identifiers

NCT03629795

TO06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:

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

Exclusion criteria

• A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:

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