title: Analytical validation based on total error measurement and cut-off interpretation of a neonatal screening TSH-immunoassay.
abstract: 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 250 mIU/L. Based on 99.5 percentile of a 16,459 newborn population, cut-off was fixed at 20.1 mIU/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.
authors.affiliation: Laboratoire de Biochimie Génétique, Centre de Génétique Humaine, CHU, University of Liège, Liège, Belgium. F.Boemer@chu.ulg.ac.be
authors.forename: François
authors.initials: F
authors.lastname: Boemer
authors.forename: Vincent
authors.initials: V
authors.lastname: Bours
authors.forename: Roland
authors.initials: R
authors.lastname: Schoos
authors.forename: Philippe
authors.initials: P
authors.lastname: Hubert
authors.forename: Eric
authors.initials: E
authors.lastname: Rozet
mesh_terms: D003409:Congenital Hypothyroidism / Q000097:blood / Q000175:diagnosis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D015997:Neonatal Screening / Q000379:methods*; D013972:Thyrotropin / Q000097:blood*
chemical_list: D013972:Thyrotropin