Istituto di Fisiologia Clinica     
Iervasi A., Iervasi G., Bottoni A., Boni G., Annicchiarico C., Di Cecco P., Zucchelli G. C. Diagnostic performance of a new high-sensitive thyroglobulin immunoassay. In: Journal of Endocrinology, vol. 182 pp. 287 - 294. Society for Endocrinology, 2004.
Serum Thyroglobulin (Tg) determination is commonly used for detecting the presence of residual thyroid tissue or cancer recurrence in patients treated for differentiated thyroid cancer (DTC). The aim of the study was to evaluate the performance characteristics of a recently introduced fully automated chemiluminescent immunoassay, based on 4 monoclonal antibodies and which produced results in 40 min. Analytical sensitivity (0.01 microg/L) was computed from 20 replicates of zero calibrator and of 'Tg-free' sample pool. Functional sensitivity (0.1 microg/L at 20 CV%) was determined from the imprecision profile obtained assaying 10 serum pools. Reliability of the measurements in the low concentration range (Tg<1 microg/L) has been checked by progressively diluting with 'Tg-free' serum a sample pool at 5.27 microg/L; measured values were very close to the expected values (recovery 100-133%). Cut-off at 99th percentile in DTC stage I 'disease-free' treated patients (n=53), was 0.16 microg/L. Tg measurement in basal condition during L-Thyroxine suppressive therapy and 5 days after rh- TSH stimulation was performed in 22 DTC patients. In 80% of patients with basal Tg<0.1 microg/L (12/15) Tg remained<0.1 microg/L after stimulation, and in all of these<1 microg/L. Our results indicate the optimal analytical and clinical performance of the Tg Access immunoassay and encourage further studies on larger population of DTC patients.
URL: http://journals.endocrinology.org/joe/182/0287/1820287.pdf
Subject Diagnostic

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