Generation and characterization of monoclonal antibodies against thyroid-stimulating hormone for newborn screening of congenital hypothyroidism

References

• Rastogi, M. V.; LaFranchi, S. H. Congenital Hypothyroidism. Orphanet J. Rare Dis. 2010, 5, 17–22. DOI: 10.1186/1750-1172-5-17.
   PubMed Web of Science ®Google Scholar
• González, E. C.; Castells, E. M.; Frómeta, A.; Arteaga, A. L.; Del Río, L.; Tejeda, Y.; Pérez, P. L.; Segura, M. T.; Almenares, P.; Perea, Y.; et al. SUMA Technology and Newborn Screening Tests for Inherited Metabolic Diseases in Cuba: An Overview of the First 30 Years. J. Inborn Errors Metab. Screen. 2016, 4, 1–9. DOI: 10.1177/2326409816661356.
   Google Scholar
• Castells, E.; González, E. C.; Frómeta, A.; Pérez, P. L.; Almenares, P.; Del Río, L.; Tejeda, Y.; Segura, M. T. Modified T4 Neonatal UMELISA® to 3 Mm Discs for a More Rational Use of Dried Blood Newborn Samples on Filter Paper. Biotec. Apl. 2013, 30, 137–141.
   Google Scholar
• Cooper, R. S.; Kennelly, J. F.; Orduñez, P. Health in Cuba. Int. J. Epidemiol. 2006, 35(4), 817–824. DOI: 10.1093/ije/dyl175.
   PubMed Web of Science ®Google Scholar
• Fernández, J. A.; Díaz, J. Some Theoretical Considerations on the Active Inquiry. Rev. Cubana Med. Gen. Integr. 2009, 25(4), 107–116.
   Google Scholar
• Sánchez, A.; Gorry, C. Immunodiagnostics: The Convergence of Biotech and Public Health. MEDICC Rev. 2013, 15(1), 7–10. DOI: 10.1590/s1555-79602013000100003.
   PubMed Web of Science ®Google Scholar
• Reed, G. Generating Appropriate Technologies for Health Equity. MEDICC Rev. 2009, 11(1), 14–17. DOI: 10.1590/medicc.2017.19040004.
   PubMed Web of Science ®Google Scholar
• Frómeta, A.; Pérez, P. L.; Lechuga, M. F.; Marrero, N.; Urquiza, H. D.; Coto, R.; Serufo, J. C.; Souza, A. M.; Souza, P. G. Desenvolvimento do UMELISA-TSH Neonatal para Dosagem de TSH em Sangue Coletado em Papel Filtro. Rev. Bras. Anal. Clin. 1996, 28(4), 202–204.
   Google Scholar
• Campbell, A. M. Monoclonal Antibody and Immunosensor Technology; Elsevier Science Publishers B.V.: Amsterdam, The Netherlands, 1991.
   Google Scholar
• Gavilondo, J. V. Anticuerpos Monoclonales; Elfos Scientiae: La Habana, Cuba, 1995.
   Google Scholar
• Baluja, I.; Brito, A.; Amores, I.; Acosta, C. Production and Characterization of Specific Monoclonal Antibodies of the Human Thyroid Stimulating Hormone. Hybridoma. 2000, 19(4), 335–338. DOI: 10.1089/027245700429891.
   PubMedGoogle Scholar
• Herrera, D.; González, E. C.; Pérez, P. L.; Frómeta, A. Normalización del UMELISA TSH NEONATAL® a discos de 3 mm. Rev. CENIC Cienc. Biol. 2006, 37(2), 119–124.
   Google Scholar
• CLSI. Protocols for Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline; CLSI document EP05-A2; Clinical and Laboratory Standards Institute: Wayne, PA, 2004.
   Google Scholar
• Wild, D. The Immunoassay Handbook; MacMillan Press Ltd: London, UK, 1994.
   Google Scholar
• CLSI. Protocols for the Determination of Detection Limits and Quantitation Limits; Approved Guideline; CLSI document EP17-A; Clinical and Laboratory Standards Institute: Wayne, PA, 2004.
   Google Scholar
• Lin, L. I. A Concordance Correlation Coefficient to Evaluate Reproducibility. Biometrics. 1989, 45(1), 255–268. DOI: 10.2307/2532051.
   PubMed Web of Science ®Google Scholar
• CECMED. D 20-17 Regulation: Good Practices in the Manufacture of Diagnosticators; Regulatory Environment; Center for the State Control of Medicaments and Medical Equipment and Devices: Havana, Cuba, 2017.
   Google Scholar
• ISO 13485. Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes; International Organization for Standardization: Geneva, Switzerland, 2016.
   Google Scholar
• Szkudlinski, M. W.; Fremont, V.; Ronin, C.; Weintraub, B. D. Thyroid-Stimulating Hormone and Thyroid-Stimulating Hormone Receptor Structure-Function Relationships. Physiol. Rev. 2002, 82(2), 473–502. DOI: 10.1152/physrev.00031.2001.
   PubMed Web of Science ®Google Scholar
• Reichert, J. M.; Rosensweig, C. J.; Faden, L. B.; Dewitz, M. C. Monoclonal Antibody Successes in the Clinic. Nat. Biotechnol. 2005, 23(9), 1073–1078. DOI: 10.1038/nbt0905-1073.
   PubMed Web of Science ®Google Scholar
• Lapthorn, A. J.; Harris, D. C.; Littlejohn, A.; Lustbader, J. W.; Canfield, R. E.; Machin, K. J.; Morgan, F. J.; Isaacs, N. W. Crystal Structure of Human Chorionic Gonadotropin. Nature. 1994, 369, 455–461. DOI: 10.1038/369455a0.
   PubMed Web of Science ®Google Scholar
• Wu, H.; Lustbader, J. W.; Liu, Y.; Canfield, R. E.; Hendrickson, W. A. Structure of Human Chorionic Gonadotropin at 2.6 Å Resolution from MAD Analysis of the Selenomethionyl Protein. Structure. 1994, 2(6), 545–558. DOI: 10.1016/S0969-2126(00)00054-X.
   PubMed Web of Science ®Google Scholar
• Benkirane, M. M.; Bon, D.; Costagliola, S.; Paolucci, F.; Darbouret, B.; Princé, P.; Carayon, P. Monoclonal Antibody Mapping of the Antigenic Surface of Human Thyrotropin and Its Subunits. Endocrinology. 1987, 121(3), 1171–1177. DOI: 10.1210/endo-121-3-1171.
   PubMed Web of Science ®Google Scholar
• Holtz, B. Denaturing and Refolding of Protein Molecules on Surfaces. Proteomics. 2007, 7(11), 1771–1774. DOI: 10.1002/pmic.200700053.
   PubMed Web of Science ®Google Scholar
• Peluso, P.; Wilson, D. S.; Do, D.; Tran, H.; Venkatasubbaiah, M.; Quincy, D.; Heidecker, B.; Poindexter, K.; Tolani, N.; Phelan, M.;; et al. Optimizing Antibody Immobilization Strategies for the Construction of Protein Microarrays. Anal. Biochem. 2003, 312(2), 113–124. DOI: 10.1016/S0003-2697(02)00442-6.
   PubMed Web of Science ®Google Scholar
• Almenares, P. R. Evaluación de un Anticuerpo Monoclonal Anti-Tirotropina Humana (Cadena β) en los Inmunoensayos Diseñados para el Diagnóstico del Hipotiroidismo Congénito. Master‘s dissertation, University of Havana, Havana, Cuba, 2013.
   Google Scholar