The CERA Study
Objectives
The main objective of this study is to determine the detection ranges of the ELISA test manufactured by Roche and of the current EPO anti-doping test (based on isoelectric focusing) after a single injection of CERA (Continuous Erythropoietin Receptor Activator).
Introduction
CERA is a synthetic EPO analog recently introduced on the market by Roche (Mircera). Its main characteristic is the fact that the EPO molecule is bound to a large polyethylene glycol moiety (PEG). PEG is capable of maintaining and extending in vivo activity of different medical drugs. Indeed, CERA’s half-life is longer and its biological activity is higher than that of native and classical recombinant EPOs. Patients that need to be treated very frequently with these types of EPO may benefit from CERA which only needs to be injected once or twice a month.
The current urine EPO anti-doping test is effective in differentiating different types of EPOs: the endogenous form, the recombinant form (rhEPO) as well as NESP. It is likely that cheating athletes will attempt to manipulate their erythropoiesis by injecting new compounds, such as CERA. To effectively fight against doping, it is necessary to carry out research on the detection of new molecules and to validate the new detection techniques that are discovered.
Methodology
The project consists in a clinical study on 6 healthy test subjects. Each individual has received a unique dose of CERA injected intravenously or subcutaneously. Urine and blood samples have been collected over a period of 1 month. These samples will be analyzed in order to compare the initial injected substance with its potential metabolites detected in the blood and in the urine. In addition, WADA current criteria for positive EPO doping will be tested in order to assess their applicability to a CERA-doped athlete.
Simplified principle of a solid support ELISA test
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