Martinez Brito Dayamin, Bueno Fis Elizabeth, Fiallo Fernandez Taimi, Torres Castellanos Mirta, Correa Vidal M Teresa, Montes De Oca Porto Rodny
a Analytical Departament , Sports Medicine Institute , Havana , Cuba.
J Immunoassay Immunochem. 2018;39(6):672-686. doi: 10.1080/15321819.2018.1531020. Epub 2018 Oct 22.
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-doping control purposes.
超微量分析系统（SUMA）是一种基于酶联免疫吸附测定（ELISA）的分析平台，由古巴免疫分析中心（IC）开发和制造，主要用于临床医学应用。在本文中，我们描述了基于SUMA的UMELISA HCG试剂盒作为尿液中人类绒毛膜促性腺激素（hCG）检测的反兴奋剂预筛查程序的验证情况。根据世界反兴奋剂机构（WADA）制定的标准，对检测性能参数进行验证，结果显示令人满意：批内重复性（6.7 - 9.7%）、批间再现性（7.8 - 10.5%）、准确性（91 - 98%）、检测限（2.7 IU/L）和线性。使用相对灵敏度和特异性以及预测阳性和阴性值来评估有效性，显示值为97.6%。应用卡帕指数分析来检查与市售参考检测方法COBAS e411（罗氏）的一致性，该方法常用于WADA认可的反兴奋剂实验室中尿液中完整（异二聚体）hCG的测量。UMELISA HCG试剂盒被认为适用于反兴奋剂控制目的。
