Evaluation of an assay for Inhibin A in Down syndrome screening

• Research type

  Research Study

• Full title

  Evaluation of an assay for Inhibin A and its application in screening for Down Syndrome

• IRAS ID

  165916

• Contact name

  Kevin Spencer

• Contact email

  kevinspencer1@aol.com

• Sponsor organisation

  Barking Havering & Redbridge University Hospitals NHS Trust

• Duration of Study in the UK

  0 years, 2 months, 28 days

• Research summary

  The study is in two parts the first is a technical performance evaluation study. The aim of this performance evaluation study is to compare the results obtained from clinical specimens using Access Inhibin A, A36097 (Beckman Coulter, Inc.) kit to results obtained with a newly available commercial kit from PerkinElmer B064-102 AutoDELFIA Inhibin A and to describe the performance characteristics of the new method.
  The second part of the study is to demonstrate the screening performance of B064-102 AutoDELFIA Inhibin A kit in screening of Down’s syndrome during 2nd trimester of pregnancy together with marker combination AFP, free hCGß/hCG and uE3 or AFP, free hCGß/hCG. To establish B064-102 AutoDELFIA Inhibin A medians for unaffected pregnancies in different gestational weeks during the 2nd trimester (weeks 14 - 20+6) of pregnancy. To demonstrate an acceptable precision of the B064-102 AutoDELFIA Inhibin A kit. To assess usability of B064-102 AutoDELFIA Inhibin A kit .

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  14/EM/1229

• Date of REC Opinion

  24 Nov 2014

• REC opinion

  Favourable Opinion