Diagnostic performance of a new highly sensitive thyroglobulin ...

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duced fully automated chemiluminescent immunoassay, based on four .... by a stored multi- point response curve calibrated to CRM 457 international reference ...

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Diagnostic performance of a new highly sensitive thyroglobulin immunoassay A Iervasi, G Iervasi, A Bottoni, G Boni1, C Annicchiarico1, P Di Cecco and G C Zucchelli National Council of Research, Institute of Clinical Physiology, Via Moruzzi, 1, 56124 Pisa, Italy 1

Division of Nuclear Medicine, Department of Oncology, University of Pisa, Pisa, Italy

(Requests for offprints should be addressed to G Iervasi; Email: [email protected])

Abstract The determination of serum thyroglobulin (Tg) 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 four monoclonal antibodies and which produces results in 40 min. Analytical sensitivity (0·01 µg/l) was computed from 20 replicates of the zero calibrator and of the ‘Tg-free’ sample pool. Functional sensitivity (0·1 µg/l at 20 coefficients of variation percent) was determined from the imprecision profile obtained by assaying ten serum pools. The reliability of the measurements in the low concentration range (Tg

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