An enzyme immunoassay to determine human chorionic gonadotropin (HCG) in serum and urine samples using an ultra-microanalytical system
| Autor: | Raquel López Cisneros, Iria García de la Rosa, Remigio Coto Rodeiro, Ruben del Valle García, Nancy L. Carrazana San Martín, Evelyn D. Gato Orozco, Delia Benítez Gordillo, Adriana González Quintero, Antonio Melchor Rodríguez, Juliette M. Cazanave Mora, Orlando Zulueta Rodríguez, Liliana Hernández Pérez, Ariel Lorenzo Rojas |
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| Rok vydání: | 2021 |
| Předmět: |
endocrine system
Clinical Biochemistry Pharmaceutical Science Early pregnancy factor Enzyme-Linked Immunosorbent Assay Urine Chorionic Gonadotropin Analytical Chemistry Human chorionic gonadotropin Pregnancy Drug Discovery medicine Biological fluids Humans Spectroscopy Tumor marker chemistry.chemical_classification Doping in Sports Immunoassay Chromatography medicine.diagnostic_test biology Chemistry Enzyme biology.protein Female hormones hormone substitutes and hormone antagonists |
| Zdroj: | Journal of pharmaceutical and biomedical analysis. 204 |
| ISSN: | 1873-264X |
| Popis: | The determination of Human Chorionic Gonadotropin (HCG) in biological fluids is of great interest in the early pregnancy diagnostics, the evaluation of pregnancy disorders, as a tumor marker, as a screening procedure for anti-doping control, and many other purposes. A simple sandwich-type UltraMicro Enzyme-Linked ImmunoSorbent Assay (UMELISA) has been developed for the measurement of HCG in serum and urine samples. Strips coated with a high affinity MAb directed against HCG are used as solid phase, to ensure the specificity of the assay. The HCG assay was completed in 1.5 h, with a measuring range of 0.76-400 mIU/mL. The intra- and inter-assay coefficients of variation were lower than 10 %, depending on the HCG concentrations evaluated. Recovery percentages were 96.43-97.16 % (serum) and 98.10-99.04 % (urine). The assay detected intact HCG, nicked HCG, HCG β, and nicked HCG β, and did not recognize any of the interfering molecules tested. Regression analysis showed a good correlation with Elecsys in serum (n = 1459, r = 0.952, ρc = 0.948) and urine (n = 869, r = 0.988, ρc = 0.978). A good correlation was also found with 84 RIQAS samples analyzed with the kits Elecsys (r = 0.969, ρc = 0.957), Architect (r = 0.982, ρc = 0.970), Dimension (r = 0.989, ρc = 0.977), and Bioscience (r = 0.992, ρc = 0.980), all with a p0.01. Comparison with transvaginal ultrasonography in early pregnancy detection showed a specificity and a sensitivity of 100 % (n = 2385, κ = 1). The analytical performance characteristics of UMELISA HCG endorse its use for the quantification of HCG in serum and urine samples. This assay will make a cost-effective diagnostic kit accessible to low-income countries and is now available in the Cuban Public Health System. |
| Databáze: | OpenAIRE |
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