Impact of different serum gel tubes on 25-hydroxyvitamin D analysis.V1
Research type
Research Study
Full title
Analytical impact of different manufacturers’ serum gel tubes on 25-hydroxyvitamin D analysis by Liquid Chromatography Tandem Mass Spectrometry
IRAS ID
174140
Contact name
Irene A A Appianing
Contact email
Sponsor organisation
Royal Liverpool And Broadgreen University Hospitals NHS Trust
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Study importance: Vitamin D functions to maintain adequate blood calcium levels and a healthy skeleton. Suboptimal levels may cause disorders e.g. rickets, osteomalacia, osteoporosis, and low calcium levels in the blood. Thus measuring patients’ vitamin D levels is important. It’s reflected in our laboratory’s increasing test demands, amounting to about £0.45million/annum. It is therefore essential that the laboratory provides accurate results to support patient care.
Gel-containing blood tubes are commonly used for most laboratory tests. However, certain manufacturer’s gel tubes have been shown to produce wrong results for some tests. We routinely recommend use of plain tubes for measuring vitamin D. However, this study will investigate if vitamin D measured using our laboratory method, is affected by using 3 popular manufacturers’ gel-containing tubes.
Aim: To investigate
1. Whether gel tubes produce different vitamin D results to plain tubes and whether this is dependant on tube manufacturer.
2. The effects of prolonged contact of blood with the gel at room temperature and in refrigeration.
3. The cause of observed interferences in the analytical method used to measure vitamin D.Potential study benefits: If gel tubes perform satisfactorily, less blood will be required from patients, appropriate blood storage conditions will be known, and laboratory performance and patient care will be improved as accurate results will be available faster.
Study Design: Laboratory study conducted at Royal Liverpool University Hospital (RLUH).
Eligible participants: 32 adult volunteers recruited from Liverpool Clinical Laboratories staff or RLUH Research & Development database.
Participant Involvement: To provide 36ml blood during single visit to RLUH.
Sample Analysis: Blood will be distributed between plain and gel-containing tubes, and the effects of prolonged storage, at room temperature or in the refrigerator, on Vitamin D measurements will be assessed. Vitamin D results from gel and plain tubes will be compared.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0465
Date of REC Opinion
13 Oct 2015
REC opinion
Favourable Opinion