An EQA scheme for TPMT activity and thiopurine metabolites v.2.2.
Research type
Research Study
Full title
Collection of blood samples for use in an external quality assurance (EQA) scheme for thiopurine S-methyl transferase (TPMT) activity and thiopurine metabolites, 6-thioguanine nucleotides (6TGN) and 6-methyl mercaptopurine nucleotides (6MMPN).
IRAS ID
194310
Contact name
Jonathan Berg
Contact email
Sponsor organisation
Sandwell and West Birmingham Hospitals NHS Trust
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Title: An external quality assurance (EQA) scheme using blood collected from Sandwell and West Birmingham Hospitals (SWBH) NHS Trust outpatients and staff volunteers. Are laboratories worldwide reporting consistent results?
The enzyme called TPMT is involved in the breakdown of thiopurine drugs (such as azathioprine), which are commonly used to treat inflammatory bowel disease and immune diseases. Different individuals in the population have different, genetically determined, levels of enzyme. An individual with no enzyme activity has a high risk of serious side effects from treatment. In routine practice, the enzyme activity in the blood is measured before starting patients’ treatment to determine an effective and safe starting dose.
Thiopurine metabolites are the breakdown products of thiopurine drugs and are monitored in the blood of patients on these drugs to optimise their drug dose.
These tests are performed by laboratories across the UK and around the world. It is important for patient care that the results are correct and comparable between different hospitals. One way of assessing this is through checking the performance of the laboratories via an ‘External Quality Assurance’ or EQA scheme. No EQA scheme currently exists for TPMT/thiopurine metabolites, which is a potential shortcoming of these tests.
Blood samples will be collected from SWBH staff volunteers and outpatients (60 mL, up to twice per over the 5 years period of the study (e.g. up to 10 times in 5 years)). Where it is not possible to find suitable blood donors, anonymised pooled surplus blood samples from the laboratory will be used instead. Our Partner organisation, UK NEQAS, is an EQA scheme provider which will send anonymised samples to participating laboratories every two months. The laboratories will test the samples and return results to UK NEQAS for comparison. A report will be compiled allowing laboratories to compare their results with other laboratories, and make changes where necessary.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0260
Date of REC Opinion
10 Aug 2016
REC opinion
Further Information Favourable Opinion