'Application of the ultra micro analytical system (SUMA) technology for the detection of urinary hCG in antidoping control'
| Autor: | Mirta Torres Castellanos, Dayamín Martínez Brito, M Teresa Correa Vidal, Rodny Montes de Oca Porto, Taimi Fiallo Fernandez, Elizabeth Bueno Fis |
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| Rok vydání: | 2018 |
| Předmět: |
Chorionic gonadotrophin
Clinical Biochemistry Immunology Enzyme-Linked Immunosorbent Assay Urine Antigen-Antibody Complex 01 natural sciences Chorionic Gonadotropin Kappa index 03 medical and health sciences 0302 clinical medicine medicine Immunology and Allergy Humans Detection limit Doping in Sports Reproducibility Chromatography medicine.diagnostic_test business.industry 010401 analytical chemistry Antibodies Monoclonal Repeatability Urinary hCG 0104 chemical sciences Substance Abuse Detection Medical Laboratory Technology 030220 oncology & carcinogenesis Immunoassay business |
| Zdroj: | Journal of immunoassayimmunochemistry. 39(6) |
| ISSN: | 1532-4230 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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