Clinical evaluation of hTSH IRMA kit developed at IFIN-HH Bucuresti

The TSH immunoradiometric assay (IRMA) presents a major interest for the diagnosis of thyroid function state. The hTSH IRMA kit has been developed at Horia Hulubei National Institute for Physics and Nuclear Engineering (IFIN-HH) in order to be used for the direct quantitative determination of hTSH in human serum or plasma in the range 0-50μUI/mL. In this paper the following results obtained at IFIN-HH and Endocrinology Institute in the kit validation are presented, namely: evaluation of performance characteristics, the correlation studies of TSH concentration measured by IFIN kit and by two validated commercial kits on patient sample and also, the normal range was established. The results obtained in the validation of the hTSH IRMA kit were the following: the intra- and interassay coefficient of variation were ≤10%, recovery = 95-110%, sensitivity ≤ 0.035μUI/mL and stability 6 weeks. The TSH concentrations measured in clinic samples by the IFIN hTSH IRMA kit and two commercial kits correlate very well. Normal range established on 143 untreated euthyroid subjects is 0.37-3. (authors)