Naslov
A third generation of TSH assay "DELFIA hTSH Ultra" evaluated

Autori
Gregurić, Nevenka ; Bence-Žigman, Zdenka

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Fourth International Congress of the Croatian Society of Nuclear Medicine, Book of Abstracts / Kasal, Božidar - Zagreb : Hrvatsko društvo za nuklearnu medicinu, 2002

Skup
Fourth International Congress of the Croatian Society of Nuclear Medicine

Mjesto i datum
Opatija, Hrvatska, 12.05.2002. - 15.05.2002

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
Thyrotropin; third generation; TSH assay; immunofluorometric assay

Sažetak
Measurement of the basal concentration of thyrotropin (TSH) in serum is one of the essential test of thyroid function. We assessed the laboratory performance and clinical utility a third generation of assay kit "DELFIA hTSH Ultra" (Wallac, Oy, Finland), and compared it with a second generation assay kit "DELFIA hTSH". "DELFIA hTSH Ultra" and "DELFIA hTSH" are two site immunofluorometric assay based on the time-resolved fluorometric measurement. These assay kits are available as manual (semiautomatic), or automated (AutoDELFIA hTSH Ultra kit).The analyses were performed according to the manufacturers, protocol by the semiautomatic method. The analytical sensitivity (2SD above the mean rate of fluorescence of zero calibrator), was estimated to be 0.007 microIU/ml for "DELFIA hTSH Ultra", and 0.009 microIU/ml for "DELFIA hTSH". The functional sensitivity, which is defined, using the precision profile, as the lowest concentration with a less than 20% interassay CV, was 0.05 microIU/ml for "DELFIA hTSH Ultra", and 0.23 microIU/ml for "DELFIA hTSH". Precision studies showed that the interassay precision is less than 4 % for "DELFIA hTSH Ultra" in the lower range of measurement of TSH. The reference range for the euthyroid patients (n=54) is 0.4-4.2 microIU/ml for "DELFIA hTSH Ultra", and 0.3-3.8 microIU/ml for "DELFIA hTSH". In the clinical evaluation, "DELFIA hTSH Ultra"is more sensitive and disseminate more clearly patients with subnormal TSH, due to hyperthyroidism, thyroxine overplacement and nonthyroidal illness, but, there is still significant overlap between results for these groups. In conclusion, "DELFIA hTSH Ultra" is highly sensitive a third generation assay for measuring of TSH, and is suitable as one of the first line test in routine laboratory work.

Izvorni jezik
Engleski

Znanstvena područja
Javno zdravstvo i zdravstvena zaštita

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