MAIIA EPO精製ゲルキット、7D3-スクリーニングおよび確認手順のための代替精製キット。血清および血漿マトリックスのバリデーション

In this study, the performance of the MAIIA EPO purification kit 7D3 was evaluated for human serum and plasma matrices. The kit was validated for selectivity in comparison to the MAIIA 3F6 kit, reliability at minimum required performance levels (MRPLs), limit of detection (LOD), carryover and recovery to meet compliance with the World Anti-Doping Agency criteria of the technical document 2024 (TD2024EPO). In addition, the influence of haemolysis on plasma samples was evaluated. In total, 30 serum samples and 30 plasma samples were tested for selectivity; 10 serum and 10 plasma samples, for reliability at MRPL and recovery; and six serum and six plasma samples, for LOD. The influence of haemolysis was evaluated by creating mixtures of 0%, 25%, 50%, 75% and 100% of a hemolytic sample and a blank sample, and the same sample spiked at the MRPL level. This study validates that the 7D3 kit meets all WADA TD2024EPO criteria, providing a reliable alternative for the purification of erythropoietin receptor agonists from human serum and plasma matrices in both screening and confirmation procedures in routine antidoping analysis.