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SummaryThe detection of TSH-receptor antibodies (TRAb) in patients with Graves’ disease is routinely used in nuclear medicine laboratories. This determination has been possible for approximately 3 years with a second generation human TRAb assay. Studies showed that this TRAb determination is diagnostically more sensitive compared to established, porcine TRAb assays. Objective: The aim of our study was to investigate, based on a ROC analysis, whether TRAb determination with the new, second generation assay allows a dependable statement about probability of occurence of relapse after radioiodine therapy in patient suffering from Graves’ disease. Methods: 57 patients were examined with the DYNOtest® TRAKhuman (BRAHMS Diagnostica AG, Hennigsdorf) directly before and six months after therapy with radioiodine (dose: 150 Gy). A ROC-analysis was performed to determine positive/negative predictive values depending on different cut-off values. Results: Whereas 21/57 patients became eu- or hypothyroid after six months, 36/57 patients relapsed. Nonrelapsed patients showed a significant lower median TRAb titer (4.2 IU/l vs. 19.2 IU/l; p <0.05) compared to relapsed patients. But the positive predictive value conducted 63 and 66, 62 and 66 as well as 63 and 69% (before and after therapy) linked with the cut-offs 1.0, 1.5, and 2.0 IU/l. So it was in areas also achieved by the first generation porcine radioreceptorassay. Conclusion: An increased sensitivity is achieved undoubtedly with the new DYNOtest® TRAKhuman in the diagnostic of Graves’ disease. It is not held over the established radioreceptorassay concerning the positive predictive value for relapsing patients.

Summary Aim: The detection of TSH-receptor-antibodies (TRAb) in patients (pts) with Graves’ disease (GD) is routinely used in nuclear medicine laboratories. It is performed by commercial, porcine radioreceptorassays (RRA) measuring TSH binding inhibitory activity. A second generation assay using the human, recombinant TSHreceptor was developed during the last years. The manufacturer composed this new assay as a coated tube RRA (CT RRA) and claimed a higher sensitivity for GD. Methods: TRAb was measured in 207 pts with various thyroid disorders and 205 healthy controls using the new coated tube RRA (Fa. B.R.A.H.M.S. Diagnostica GmbH, Berlin, Germany) as well as a conventional RRA (Fa. Medipan Diagnostica GmbH, Selchow, Germany): 60 pts suffering from GD showing a relapse after antithyroid drug treatment and before radioiodine therapy, 109 pts with disseminated autonomia (DA) and 38 pts suffering from Hashimoto’s thyroiditis. A ROC-analysis was performed to find the optimal decision threshold level for positivity. Results: We found 42/60 TRAbpositive pts with GD in the established RRA (threshold 6 U/L) and 52/60 in the CT RRA, respectively. The sensitivity increased from 70% (RRA) to 86,7% (CT RRA). The CT RRA found 2 false positives (one Hashimoto’s and one healthy control) and the RRA detected 3 Hashimoto’s and 2 healthy controls as false positive. Conclusion: The increased sensitivity of CT RRA for GD provides an advantage compared to conventional RRA, especially in GD-patients relapsing after antithyroid drug treatment. Functional sensitivity and Interassayvariation of CT RRA are very precisely compared to conventional RRA. Handling of the new assay is also improved.

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