Objective: To evaluate a highly sensitive thyroglobulin (Tg) assay [functional sensitivity (FS): 0.1 ng/ml] (Tg-ICMA) in low-risk patients with known Tg on T4 < or = 1 ng/ml measured by a traditional assay (FS: 1 ng/ml) (Tg-IRMA).
Methods: Tg-ICMA was measured in serum samples stored at -70 degrees C. Samples were obtained 6 months or more after total thyroidectomy and remnant ablation with (131)I, during L-T4 therapy (TSH < 0.4 mIU/l). All patients had well-differentiated and completely resected tumours, no ectopic uptake on post-therapy whole-body scans and were considered to be at low risk for recurrence. On the occasion of collection and retesting for this study, Tg-IRMA was < or = 1 ng/ml in all samples and no antibody interference was observed.
Results: Tg-ICMA < or = 0.1 ng/ml was observed in 130/178 (73%) patients and recurrence was diagnosed in only 1/130 (0.8%). Tg-IRMA measured after L-T4 withdrawal was > 1 ng/ml in 5/130 (3.8%) patients. Forty-eight (27%) patients had Tg-ICMA > 0.1 ng/ml (0.12-1.6 ng/ml) and recurrence was diagnosed in 5/48 (10.5%). Tg-IRMA measured after L-T4 withdrawal was > 1 ng/ml in 20/48 (41.6%) patients. A negative predictive value of 100% was achieved with Tg-ICMA on T4 < or = 0.1 ng/ml combined with neck ultrasonography (US) or with stimulated Tg-IRMA < or = 1 ng/ml.
Conclusions: Patients at low risk for recurrence with undetectable Tg on T4 measured by a highly sensitive assay (FS: 0.1 ng/ml) in the absence of antibody interference and with a negative sensitive neck US do not need to be submitted to Tg stimulation. Recurrence is rare in these cases and only a minority of patients convert to stimulated Tg > 1-2 ng/ml.