medigraphic.com
ISSN 1027-2852 (Electronic)
ISSN 0864-4551 (Print)

2013, Number 2

<< Back Next >>

Biotecnol Apl 2013; 30 (2)

Modified T4 Neonatal UMELISA® to 3 mm discs for a more rational use of dried blood newborn samples on filter paper

Castells E, González EC, Frómeta A, Pérez PL, Almenares P, del Río L, Tejeda Y, Segura MT

Language: English
References: 29
Page: 137-141
PDF size: 183.87 Kb.


ABSTRACT

Congenital hypothyroidism (CH) is one of the most common preventable causes of mental retardation. Newborn screening and thyroid therapy started within 2 weeks of age can normalize the cognitive and motor impairment caused by lack of thyroid hormone during the early postnatal phase of brain development. The availability of assays to determine thyroxin (T4) and thyroid stimulating hormone has allowed the establishment of newborn screening programs for CH. The Immunoassay Center (Cuba) developed the T4 Neonatal UMELISA® to determine neonatal T4 levels in dried blood on fi lter paper using 5 mm discs of samples, standards and controls. The number of diseases which can be diagnosed in Neonatal Screening Programs has increased, so it is necessary to make the maximum use of blood samples collected on fi lter paper. This work shows the standardization of the T4 Neonatal UMELISA® modified in order to use 3 mm discs. The assay was completed in 3 ½ hours, with a measuring range of 25-400 nmol/L. The intra- and inter-assay coefficients of variation (CV) were 6-10 % and 7-12 % respectively, depending on the T4 concentrations. The recovery ranged from 91.8-115.1 %. The modified assay showed high Pearson correlation (r = 0.877) and concordance correlation (ρc = 0.867) with the T4 Neonatal UMELISA®. The performed modifications do not affect the sensitivity, precision and accuracy of the assay, permitting a more rational use of newborn blood samples and the possibility to increase the number of diseases included in the newborn screening programs.


REFERENCES

  1. Klein AH, LaFranchi S, Larsen PR, et al. Screening for congenital hypothyroidism: results of screening one million North American infants. J Pediatr. 1979; 94(5):700-5.

  2. Fisher DA. Second International Conference on Neonatal Thyroid Screening: progress report. J Pediatr. 1983; 102(5):653-4.

  3. Aliño M. El programa de pesquisa neonatal en Cuba. In: I Congreso Latinoamericano de Pesquisa Neonatal y Enfermedades Heredometabólicas. Ciudad de La Habana, Cuba; 1997. p. 28.

  4. Guell R, Robaina R, Álvarez MA, Fernández JL. Más de 10 años de pesquisaje neonatal de hipotiroidismo congénito. In: I Congreso Latinoamericano de Pesquisa Neonatal y Enfermedades Heredo metabólicas. Ciudad de La Habana, Cuba, 1997. p. 41.

  5. Rastogi MV, LaFranchi SH. Congenital hypothyroidism. Orphanet J Rare Dis. 2010;5:17.

  6. Rose SR, Brown RS, Foley T, Kaplowitz PB, Kaye CI, Sundararajan S, et al. Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics. 2006;117(6):2290-303.

  7. American Academy of Pediatrics AAP Section on Endocrinology and Committee on Genetics, and American Thyroid Association Committee on Public Health: Newborn screening for congenital hypothyroidism: recommended guidelines. Pediatrics. 1993;91(6):1203-9.

  8. Fisher DA. Congenital hypothyroidism. Thyroid Int. 2002;3:3-10.

  9. van Tijn DA, de Vijlder JJ, Verbeeten B, Jr., Verkerk PH, Vulsma T. Neonatal detection of congenital hypothyroidism of central origin. J Clin Endocrinol Metab. 2005;90(6):3350-9.

  10. Almenares P, Lechuga MF, Marrero N, Solís RL, Frómeta A, Robaina R, et al. Development of UMELISA T4 Neonatal for the early diagnosis of congenital hypothyroidism. In: Levy HL, Hermos RJ, Grady GF, editors. Proceedings of third meeting of the international society for neonatal screening; 1996 Oct 20-23; Boston, EUA. Massachusetts: IKON/MAP; 1996. p. 240-1.

  11. Marrero N, Zulueta O, González EC, Montalvo G, Pérez PL, Melchor A. Obtention of 17α-hydroxyprogesterone/ alkaline phosphatase conjugates for use in the diagnosis of congenital adrenal hyperplasia. Rev CENIC Cienc Biol. 2003; 34(1):23-8.

  12. Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45(1):255-68.

  13. Clinical and Laboratory Standards Institute (CLSI). Protocols for determination of limits of detection and limits of quantitation; approved guideline. CLSI document EP17-A. Wayne, PA: CLSI; 2004.

  14. Dussault JH, Coulombe P, Laberge C, Letarte J, Guyda H, Khoury K. Preliminary report on a mass screening program for neonatal hypothyroidism. J Pediatr. 1975; 86(5):670-4.

  15. Revised guidelines for neonatal screening programmes for primary congenital hypothyroidism. Working Group on Neonatal Screening of the European Society for Paediatric Endocrinology. Horm Res. 1999;52(1):49-52.

  16. Lafranchi SH, Snyder DB, Sesser DE, Skeels MR, Singh N, Brent GA, et al. Follow-up of newborns with elevated screening T4 concentrations. J Pediatr. 2003;143(3):296-301.

  17. Prieto L, Gruñeiro de Papendieck L, Chiesa A, Bergadá C. Screening of congenital hypothyroidism (CH): experience in cord blood. In: Levy HL, Hermos RJ, Grady GF, editors. Proceedings of the third meeting of the international society for neonatal screening; 1996 Oct 22-23; Boston, EUA. Massachusetts: IKON/MAP; 1996. p. 271-2.

  18. Derksen-Lubsen G, Verkerk PH. Neuropsychologic development in early treated congenital hypothyroidism: analysis of literature data. Pediatr Res. 1996;39(3):561-6.

  19. Álvarez MA, Carvajal-Martínez F, Pérez- Gesén C, Olivares-Torres A, Fernández-Yero JL, Robaina-Álvarez R, et al. Pronóstico de la cognición en el hipotiroidismo congénito tratado precozmente. Hipótesis del doble efecto. Rev Neurol. 2004;38(6):513-7.

  20. LaFranchi SH, Austin J. How should we be treating children with congenital hypothyroidism? J Pediatr Endocrinol Metab. 2007; 20(5):559-78.

  21. Mei JV, Alexander JR, Adam BW, Hannon WH. Use of fi lter paper for the collection and analysis of human whole blood specimens. J Nutr. 2001;131(5):1631S-6S.

  22. Gonzalez EC, Marrero N, Frometa A, Herrera D, Castells E, Perez PL. Qualitative colorimetric ultramicroassay for the detection of biotinidase defi ciency in newborns. Clin Chim Acta. 2006;369(1):35-9.

  23. Herrera D, González EC, Pérez PL, Frómeta A. Normalización del UMELISA TSH NEONATAL® a discos de 3 mm. Rev CENIC Cienc Biol. 2006; 37(2):119-24.

  24. Gonzalez EC, Marrero N, Perez PL, Frometa A, Zulueta O, Herrera D, et al. An enzyme immunoassay for determining 17alpha-hydroxyprogesterone in dried blood spots on fi lter paper using an ultramicroanalytical system. Clin Chim Acta. 2008;394(1-2):63-6.

  25. Gonzalez EC, Frometa A, del Rio L, Castells E, Robaina MS, Garcia SM, et al. Cuban neonatal screening of phenylketonuria using an ultramicro-fl uorometric test. Clin Chim Acta. 2009;402(1-2):129-32.

  26. Frometa A, Reyes EC, Castells E, Tejeda Y, Almenares P, Perez PL. Quantitative ultramicrotest for newborn screening of galactosemia in Cuba. J Perinat Med. 2011;39(1):77-81.

  27. Gruneiro-Papendieck L, Prieto L, Chiesa A, Bengolea S, Bossi G, Bergada C. Usefulness of thyroxine and free thyroxine fi lter paper measurements in neonatal screening for congenital hypothyroidism of preterm babies. J Med Screen. 2000;7(2):78-81.

  28. Larsson A, Ljunggren JG, Ekman K, Nilsson A, Olin P. Screening for congenital hypothyroidism. I. Laboratory results of a pilot study based on dried blood samples collected for PKU screening. Acta Paediatr Scand.1981;70(2):141-6.

  29. Gonzalez RR, Robaina R, Rodriguez ME, Blanca S. An enzyme immunoassay for determining total thyroxine in human serum using an ultramicroanalytical system. Clin Chim Acta. 1991;197(3):159-70.




2020     |     www.medigraphic.com