An enzyme immunoassay to determine human chorionic gonadotropin (HCG) in serum and urine samples using an ultra-microanalytical system

An enzyme immunoassay to determine human chorionic gonadotropin (HCG) in serum and urine samples using an ultra-microanalytical system / Ruben Del Valle García, Juliette M. Cazanave Mora, Nancy L. Carrazana San Martín, Orlando Zulueta Rodríguez, Antonio Melchor Rodríguez, Liliana Hernández Pérez, Raquel López Cisneros, Evelyn D. Gato Orozco, Delia Benítez Gordillo, Adriana González Quintero, Iria García de la Rosa , Remigio Coto Rodeiro. - (Journal of Pharmaceutical and Biomedical Analysis 104 (2021) 10 September; 114239)

  • PMID: 34252818
  • DOI: 10.1016/j.jpba.2021.114239


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 p < 0.01. 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.


2 July 2021
Benítez Gordillo, Delia
Carrazana San Martin, Nancy L.
Cazanave Mora, Juliette M.
Coto Rodeiro, Remigio
García de la Rosa, Iria
Gato Orozco, Evelyn D.
González Quintero, Adriana
Hernández Pérez, Liliana
López Cisneros, Raquel
Melchor Rodríguez, Antonio
Valle García, Ruben
Zulueta Rodríguez, Orlando
Other organisations
Cuban Center for Immunoassay (CEI)
Hospital Ramón González Coro
Analytical aspects
Testing method development
Doping classes
S2. Peptide Hormones, Growth Factors
Human chorionic gonadotrophin (hCG)
Medical terms
Doping control
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Date generated
31 August 2021
Date of last modification
1 September 2021
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