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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Development, characterization and clinical validation of new sensitive immunofluorometric assay for the measurement of serum thyroglobulin

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Author(s):
Nakabashi, Claudia C. D. [1, 2] ; Biscolla, Rosa Paula M. [3, 1, 2] ; Kasamatsu, Teresa S. [1] ; Tachibana, Teresinha T. [3] ; Barcelos, Rafaela N. [1] ; Malouf, Eduardo Z. [2] ; Andreoni, Danielle M. [1, 2] ; Maciel, Rui M. B. [3, 1, 2] ; Vieira, Jose Gilberto H. [3, 1]
Total Authors: 9
Affiliation:
[1] Univ Fed Sao Paulo, Escola Paulista Med, Disciplina Endocrinol, Lab Endocrinol Mol & Translac, Dept Med, Unifesp, BR-0403932 Sao Paulo - Brazil
[2] IIEPAE, Ctr Doencas Tiroide, Sao Paulo - Brazil
[3] Fleury Med & Saude, Sao Paulo - Brazil
Total Affiliations: 3
Document type: Journal article
Source: Arquivos Brasileiros de Endocrinologia e Metabologia; v. 56, n. 9, p. 658-665, DEC 2012.
Web of Science Citations: 7
Abstract

OBJECTIVE: In the last decade, data published stressed the role of highly-sensitive thyroglobulin (Tg) assays in the follow-up of differentiated thyroid carcinoma (DTC) patients. The present study describes a new, highly-sensitive Tg assay, compares it with an available commercial assay, and validates it in the follow-up of DTC patients. SUBJECTS AND METHODS: The immunofluorometric high-sensitivity Tg assay is based on monoclonal and polyclonal antibodies produced at our laboratories. It was validated in 100 samples of 87 patients with DTC submitted to total thyroidectomy, 87% of whom also received radioiodine. For correlation, all samples were also tested using a commercial Tg assay (Beckman Access) with functional sensitivity (FS) of 0.1 ng/mL. RESULTS: The new method showed FS of 0.3 ng/mL. The correlation between the two methods was good (r = 0.74; p < 0.0001). The diagnostic sensitivity was 88.9%, and it was increased to 100% when combined with neck US. CONCLUSION: This new, high-sensitivity Tg assay presented a good correlation with Beckman Access assay and with the clinical outcome of the patients. The continuous availability of a validated assay is an additional advantage for long term follow-up of DTC patients. Arq Bras Endocrinol Metab. 2012;56(9):658-65 (AU)