[en] To prevent the severe developmental and physical morbidities associated with congenital hypothyroidism, we developed a home-made Enzyme-Linked Immunosorbent Assay (ELISA) method to quantify Thyroid Stimulating Hormone (TSH) levels on newborn dried blood spots. In order to agree with actual clinical laboratory quality referential (ISO 15189), we desired to update our analytical validation protocol. For this purpose, an approach using accuracy profiles based on tolerance intervals for the total error measurement was for first time applied to an immunological assay. According to acceptance limits fixed at +/-30%, the method was found accurate over a concentration range from 17.48 to 250mIU/L. Based on 99.5 percentile of a 16,459 newborn population, cut-off was fixed at 20.1mIU/L and validated against normal and pathologic neonatal populations. Additionally, uncertainty regions around this value were obtained applying four different approaches. Finally, we demonstrated here our in-house immunological technique fulfils criterions of a neonatal screening policy.
Disciplines :
Biochemistry, biophysics & molecular biology
Author, co-author :
Boemer, François ; Centre Hospitalier Universitaire de Liège - CHU > Génétique
Bours, Vincent ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Génétique générale et humaine
Schoos, Roland ; Centre Hospitalier Universitaire de Liège - CHU > Génétique
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Analytical validation based on total error measurement and cut-off interpretation of a neonatal screening TSH-immunoassay.
Publication date :
2009
Journal title :
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Dussault J.H., Coulombe P., Laberge C., Letarte J., Guyda H., and Khoury K. J. Pediatr. 86 (1975) 670
Irie M., Enomoto K., and Naruse H. Lancet 2 (1975) 1233
Klein A.H., Agustin A.V., and Foley Jr. T.P. Lancet 2 (1974) 77
ISO 15189 Medical Laboratories - Particular requirements for quality and competence, International Organization for Standardization (ISO), 2007.
Gonzales A.G., and Herrador M.A. Talanta 70 (2006) 896
Rozet E., Morello R., Lecomte F., Martin G.B., Chiap P., Crommen J., Boos K.S., and Hubert P. J. Chromatogr. B 844 (2006) 251
Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.A., Dewe W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., and Rozet E. J. Pharm. Biomed. Anal. 45 (2007) 82
Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., and Rozet E. J. Pharm. Biomed. Anal. 45 (2007) 70
Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. J. Pharm. Biomed. Anal. 36 (2004) 579
Harlow E., and Lane D. Antibodies: A Laboratory Manual (1988), Cold Spring Harbor Laboratory Press
Tijssen P., and Kurstak E. Anal. Biochem. 136 (1984) 451
Nakane P.K., and Kawaoi A. J. Histochem. Cytochem. 22 (1974) 1084
DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., and Celniker A. Pharm. Res. 20 (2003) 1885
Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., and Weiner R. Pharm. Res. 24 (2007) 1962
Hubert P., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce P., Lallier M., Laparra M., Laurentie M., and Nivet J. Anal. Chim. Acta 391 (1999) 135
Boulanger B., Dewé W., Gilbert A., Govaerts B., and Maumy-Bertrand M. Chemometr. Intell. Lab. Syst. 896 (2007) 198
Rozet E., Wascotte V., Lecouturier N., Preat V., Dewe W., Boulanger B., and Hubert P. Anal. Chim. Acta 591 (2007) 239
Rodbard D., Feldman Y., Jaffe M.L., and Miles L.E. Immunochemistry 15 (1978) 77
ISO 5725 Application of the statistics-accuracy (trueness and precision) of the results and methods of measurement. Part 1 to 6, International Organization for Standardization (ISO), 1994.
Rozet E., Ceccato A., Hubert C., Ziemons E., Oprean R., Rudaz S., Boulanger B., and Hubert P. J. Chromatogr. A 1158 (2007) 111
Neto E.C., and Schulte J. Clin. Chem. 44 (1998) 2372
Hofman L.F., Foley Jr. T.P., Henry J.J., and Naylor E.W. J. Med. Screen. 10 (2003) 5
Delange F. Thyroid 8 (1998) 1185
Delange F. Acta Paediatr. Suppl. 88 (1999) 21
Copeland D.L., Sullivan K.M., Houston R., May W., Mendoza I., Salamatullah Q., Solomons N., Nordenberg D., and Maberly G.F. Public Health Nutr. 5 (2002) 81
McElduff A., McElduff P., Gunton J.E., Hams G., Wiley V., and Wilcken B.M. Med. J. Aust. 176 (2002) 317
WHO. Assessment of Iodine Deficiency Disorders and Monitoring their Elimination: A Guide for Programme Managers (2007), World Health Organization, Geneva
CB EA-4/16, EA Guidelines on the expression of uncertainty in quantitative testing, 2004, http://www.european-accreditation.org.
Eurachem/Citac guide quantifying the uncertainty in analytical measurement, second ed., 2000.
