title: High-sensitive 2nd generation thyroglobulin immunoradiometric assay. Clinical application in differentiated thyroid cancer management.
abstract: BACKGROUND
  Circulating human thyroglobulin (hTG) measurements have a pivotal role in the management of patients affected by differentiated thyroid cancer (DTC). The present study was undertaken by employing a new developed high-sensitive hTG immunoradiometric assay to evaluate its diagnostic performance in patients affected by radically cured and relapsing DTC and to set the most appropriate cut-off point for DTC management.
  
  
  METHODS
  We retrospectively selected 172 patients without signs of recurrence after primary treatment and 45 patients with recurrences from DTC. Serum samples were collected during l-thyroxine (T4) suppressive therapy (onT4) and 4 weeks after T4 withdrawal (offT4) and hTG measured by a specific high-sensitive IRMA assay (DYNOtest Tg-plus, BRAHMS Diagnostica GmbH, Berlin, Germany). Sera showing the presence of AbhTG or hTG-recovery less than 80% were excluded from the study. ROC curve analysis was performed to select the best cut-off levels and diagnostic performance of the marker evaluated.
  
  
  RESULTS
  By using onT4 cut-off level of 0.2 ng/mL and offT4 cut-off level of 0.5 ng/mL we obtained a sensitivity/specificity/accuracy profile of 0.91/0.98/0.96 and 0.98/0.97/0.97, respectively. We found onT4-hTG false-negative results in 4 patient with local recurrence (n=2) or cervical lymph-node metastasis (n=2) while only 1 patient with local recurrence showed negative offT4-hTG. However, onT4 and offT4-hTG false-negative results were observed in 9 and 5 patients when 1.0 ng/mL cut-off level was employed.
  
  
  CONCLUSIONS
  On the basis of our data, we conclude that DYNOtest Tg-plus assay is very effective and accurate in the evaluation of patients with DTC.
authors.affiliation: Laboratory of Endocrinology and Thyroid Unit, Department of Nuclear Medicine, University Hospital Ospedale di Circolo e Fondazione Macchi, Varese, Italy. lucamednuc@libero.it
authors.forename: L
authors.initials: L
authors.lastname: Giovanella
authors.forename: L
authors.initials: L
authors.lastname: Ceriani
authors.forename: S
authors.initials: S
authors.lastname: Garancini
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D002648:Child; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D015592:Immunoradiometric Assay / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000473:pathology* / Q000628:therapy*; D012372:ROC Curve; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013954:Thyroglobulin / Q000097:blood*; D013964:Thyroid Neoplasms / Q000097:blood* / Q000473:pathology / Q000628:therapy
chemical_list: D015415:Biomarkers; D013954:Thyroglobulin