EXSPECT
Research type
Research Study
Full title
ELF Cross comparison between Serum and Plasma Collection Tubes
IRAS ID
300708
Contact name
William Rosenberg
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust R&D
Clinicaltrials.gov Identifier
141471, R&D
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
The Enhanced Liver Fibrosis (ELF) test is a “best in class” non-invasive liver fibrosis blood test that has been established for use in all chronic liver diseases (CLD) for the diagnosis, monitoring and prognostication of chronic liver disease and liver fibrosis. The test has been established using serum samples collected into serum separation tubes. However many tests routinely performed in the investigation of CLD require plasma samples. It is not known if the ELF test can be measured in plasma and if so, whether it is preferable to collect plasma samples in tubes containing di-potassium EDTA (dKEDTA), tri-potassium EDTA (tKEDTA), sodium heparin (NaHep) or lithium heparin (LiHep), the common agents used to preserve plasma for laboratory testing. If ELF can be measured accurately in plasma this will widen the application of the test and reduce the number of samples that need to be obtained from individual patients in the course of routine blood testing.
We aim to investigate the similarity and differences in ELF test results obtained from measurement in plasma samples collected into EDTA and lithium heparin tubes compared to the reference standard of serum collected into serum separation tubes all collected from participants in one blood draw.
This research is being performed to determine if ELF test results obtained from plasma samples collected in tubes containing dK-EDTA or tK-EDTA or LiHep or NaHep yield results that are the same or clinically acceptably close to those obtained from serum samples collected in SST.REC name
North of Scotland Research Ethics Committee 2
REC reference
21/NS/0117
Date of REC Opinion
25 Aug 2021
REC opinion
Favourable Opinion