Validation of molecular assay for foetal Rh D genotype
Research type
Research Study
Full title
Validation of assay for foetal Rh D genotype in antenatal patients
IRAS ID
195667
Contact name
Kieran Morris
Contact email
Sponsor organisation
NIBTS
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a standard laboratory validation assay study comparing the use of foetal DNA from maternal antenatal blood samples at two different stations of pregnancy with the result determined at birth.
A booking sample which is drawn at 10-16 weeks pregnancy will be validated. This generates a small amount of foetal DNA in the laboratory process. A third trimester sample which is drawn at 27-29 weeks will be validated. This test is deployed in antenatal care services in other European countries and is the subject of a National Institute for Healthcare and Clinical Excellence consultation.
For laboratory validation of the assay and NIBTS internal control procedures, 500 samples are required for validation of each scenario of testing.
The predicted result will then be matched with the obtained result in the new born.
This is the purpose of the study and there is no clinical intervention or change to the provision of routine antenatal care.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0368
Date of REC Opinion
11 Oct 2016
REC opinion
Further Information Favourable Opinion