title: Impact of the introduction of high-affinity specific monoclonal antibodies in the improvement of sensitivity and specificity parameters of UMELISA HBsAg PLUS and UMELISA TSH immunoenzymatic techniques.
abstract: Improvement in the sensitivity and specificity of UMELISA techniques as a result of the introduction of monoclonal antibodies superseding the use of polyclonal antibodies was studied. For this purpose, we performed a comparison of the results in the functioning of the screening programs before and after the introduction of monoclonal antibodies. We analyzed some parameters such as sensitivity, specificity and detection limit in the UMELISA HBsAg PLUS and UMELISA TSH techniques. The sensitivity and specificity parameters were evaluated by means of comparison with the commercial assays. The detection limit was calculated as the fluorescence of the calibrator 0 + 2 standard deviations. Since the introduction of MAb obtained for us an increase in the sensitivity, specificity, and positive predictive value was evidenced. On the other hand, the use of the MAb guarantees better stability in the diagnostic kit production process.
authors.affiliation: Laboratorio de Anticuerpos Monoclonales, Centro de Inmunoensayo, Calle 134 y ave. 25, Apartado 6653, Cubanacán, Playa, Havana City, Cuba. iqmonoclo@cie.sld.cu
authors.forename: Carmen
authors.initials: C
authors.lastname: Acosta Bas
authors.forename: Maya
authors.initials: M
authors.lastname: Rodríguez López
authors.forename: Ileana B
authors.initials: IB
authors.lastname: Baluja Conde
authors.forename: Adys I
authors.initials: AI
authors.lastname: Brito Moreno
authors.forename: Sadys
authors.initials: S
authors.lastname: Feal Carballo
authors.forename: Fidel
authors.initials: F
authors.lastname: Bencomo Gómez
authors.forename: Marta
authors.initials: M
authors.lastname: Sonia Robaina
authors.forename: Susana
authors.initials: S
authors.lastname: García Izquierdo
authors.forename: Amarilys
authors.initials: A
authors.lastname: Frómeta Suárez
authors.forename: Aurora
authors.initials: A
authors.lastname: Delahanty Fernández
mesh_terms: D000486:Allergy and Immunology / Q000295:instrumentation*; D000911:Antibodies, Monoclonal / Q000737:chemistry*; D001782:Blood Donors; D002138:Calibration; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006514:Hepatitis B Surface Antigens / Q000032:analysis / Q000097:blood; D006801:Humans; D007037:Hypothyroidism / Q000175:diagnosis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D006514:Hepatitis B Surface Antigens