Optimization and Validation of an Immunoassay Method

Congenital hypothyroidism (CH) is a disease manifested by severe physical and mental deficiencies in newborns. Neonatal thyrotropin measurement (TSH-NN) enables early diagnosis of this condition. The consequences of HC can be avoided if replacement therapy is started at birth. This justifies the introduction of systematic screening programs for all newborns in most industrialized countries. With this in mind, we have developed an immuno-radiometric TSH-NN assay system. This paper describes the development process and the results of the methodological validation study, in accordance with current requirements and standards. The results of the evaluation of all performance criteria are in line with expectations. Analysis carried out with our kit on a number of samples produced results comparable to those obtained with commercial kits. This reliable, easy-to-perform, locally-developed assay system will be widely applied in periodic or routine HC screening.