Summary:
Aim of our study was to evaluate the increasing sensitivity within three generations of thyroglobulin (Tg) as-says, which were available during the past decade, and its clinical impact for patients with differentiated thyroid carcinoma. Methods: Determination of Tg using the IRMA introduced in 1989 (Dynotest®Tg, Henning Berlin, Berlin; assay A) and 1994 (Selco®Tg, Medipan Diagnostica, Selchow; assay B), as well as the IEMA available recently (Medizym®Tg Rem, Medipan Diagnostica, Selchow; assay C). Results: We found a close correlation between the measurable Tg values of assay A and B (r = 0.985; p <0.001) as well as assay B and C (r = 0.978; p <0.001). Assay B (lowest detection limit: 0.3 ng/ml) was more than twice as sensitive as assay A and did not show quite as many disturbances of recovery (in 0.5% versus 4% of our patients). Due to its strict calibration to the European reference preparation CRM 457, Tg values determined by assay C were in the mean 1.9-fold higher than by assay B. Thus, with its functional sensitivity of 0.03 ng/ml assay C is nearly 20-fold more sensitive than assay B. Whereas the proportion of measurable Tg values was only 22% in a selected group of patients (criterion of inclusion: Tg in assay B ≤1 ng/ml with TSH-suppressive conditions; n = 317 serum samples from 103 patients), it was 68% in assay C, with good intraindividual reproducibility of these values in the course. Conclusion: The ultrasensitive assay C is especially suitable for the follow-up of treated thyroid cancer patients being considered as cured, and may shorten the time interval until the detection of a recurrence markedly: the gain of time calculated from the Tg courses in patients with a gradually progressive tumor relapse ranged from 5 to 15 months.