"Application of the ultra micro analytical system (SUMA) technology for the detection of urinary hCG in antidoping control".

"Application of the ultra micro analytical system (SUMA) technology for the detection of urinary hCG in antidoping control". J Immunoassay Immunochem. 2018 Oct 22;:1-15 Authors: Martinez Brito D, Bueno Fis E, Fiallo Fernandez T, Torres Castellanos M, Correa Vidal MT, Montes De Oca Porto R Abstract The Ultra Micro Analytical System (SUMA) is an ELISA-based analytical platform, developed andmanufactured by the Cuban Immunoassay Center (IC), which is primarily used in clinical medicine applications. In this article, we describe the validation of the UMELISA HCG kits, which are based on SUMA, as a pre-screening procedure for the detection of human Chorionic Gonadotrophin (hCG) in urine for anti-doping purposes. Validation of assay performance parameters showed satisfactory results, in accordance with the criteria established by the World Anti-Doping Agency (WADA): intra-assay repeatability (6.7-9.7%), inter-assay reproducibility (7.8-10.5%), accuracy (91-98%), limit of detection (2.7 IU/L), and linearity. Relative sensitivity and specificity and Predictive Positive and Negative Values were used to evaluate the Efficacy showing a value of 97.6%. A Kappa Index analysis was applied to check agreement with the commercially available, reference assay COBASe411 (Roche), which is often applied in WADA-accredited anti-doping laboratories for measurement of intact (heterodimeric) hCG in urine. UMELISA HCG kits are considered as fit for anti-dopin...
Source: Journal of Immunoassay and Immunochemistry - Category: Biochemistry Tags: J Immunoassay Immunochem Source Type: research