First Trimester Pregnancy Biochemical Marker Performance Evaluation

• Research type

  Research Study

• Full 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

• IRAS ID

  205888

• Contact name

  Stephen Robson

• Contact email

  s.c.robson@ncl.ac.uk

• Sponsor organisation

  Axis Shield Diagnostics

• Duration of Study in the UK

  0 years, 4 months, 0 days

• Research summary

  Pregnant women are routinely offered a screening test for Down's syndrome, Edwards' syndrome and Patau's syndrome from 10-14 weeks of pregnancy (called the combined test). This is to assess the chance of having a baby with these conditions.
  The combined test involves an ultrasound scan and two blood tests (Pregnancy Associated Plasma Protein A (PAPP-A) and Free Beta Human Chorionic Gonadotropin (Free βhCG)).
  The study sponsor, Axis Shield Diagnostics, have developed blood tests for use in the combined test that will be run on a particular laboratory analyser (the ADVIA Centaur).
  Part of the directions for using the tests instruct the operators how to take, store and process the blood samples before the tests are run. These instructions must be tested to ensure that the results are not affected by any of the blood handling steps.
  Women in the first trimester of pregnancy who meet the eligibility criteria, have been fully informed and provided written consent will donate venous blood for the study.
  Participants will donate additional venous blood (up to a maximum of 33 mL in total) taken from the same venepuncture as the one used for standard of care testing.
  Samples collected will be shipped to the sponsor’s laboratory to establish the following analytical performance characteristics of the ADVIA Centaur PAPP-A and Free βhCG assays:
  1. Effect of sample tube type
  To demonstrate equivalence across different specimen types using matched sets of patient samples obtained using different blood collection tube types
  2. Refrigerated, ambient and frozen storage stability
  To determine sample handling and stability claims for refrigerated, room temperature and frozen sample storage
  3. Time to centrifugation
  To determine sample handling and stability claims for time from venepuncture to centrifugation
  4. Stability over freeze thaw cycles
  To determine sample handling and stability claims for multiple freeze thaw cycles

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  16/NE/0163

• Date of REC Opinion

  31 May 2016

• REC opinion

  Further Information Favourable Opinion