Elecsys cobas

For full details of the study design see (22 (link)). The project was approved by the Johannes Gutenberg University (JGU) Medical Center Institutional Review Board and all patients provided signed informed consent. We analyzed DNA purified from patients that participated in the Iscalimab study. For a detailed description of the study protocol, inclusion and exclusion criteria, and outcomes see (22 (link)). Briefly, GD patients were enrolled at the endocrine clinic of the JGU Medical Center. GD was diagnosed by evidence of biochemical hyperthyroidism with thyrotoxic symptoms, and positive TSHR-Ab measured by the Roche Cobas Elecsys electrochemiluminescence immunoassay (Roche Diagnostic Corporation). The treatment period lasted 12 weeks and patients received 10 mg/kg Iscalimab IV at weeks 0, 2, 4, 8, and 12. Patients were followed up for 24 weeks after completing the Iscalimab treatment course. Worsening disease at follow-up was defined as relapse of symptoms and signs of thyrotoxicosis, or significant increase in serum thyroid hormone levels requiring additional medications. Response to Iscalimab was defined as normalization of thyroid functions at the completion of the study without the need for additional medications. Partial response was defined as normalization of peripheral free thyroid hormones with persistently suppressed serum TSH.

Three different troponin assay methods were used during the course of the study according to local routines. Troponin I (Stratus CS, Siemens, ULN: 0,07 μg/L), Troponin T (AQT 90, Radiometer, ULN: 0,01 μg/L) and hs-Troponin T (Elecsys/Cobas, Roche Diagnostics, ULN: 15 ng/L).

Serum concentrations of TSH (normal range, 0.35–4.94 IU/mL), free T4 (normal range, 0.70–1.48 ng/dL), and T3 (normal range, 0.58–1.59 ng/mL) for thyroid function evaluation were measured by microparticle chemiluminescence immunoassay (Abbott Ireland Diagnostics Division, Longford, Ireland). TRAb levels were measured by two different methods: M22-TRAb (TRAb) was measured by a third-generation TBII electrochemiluminescence immunoassay (Elecsys/Cobas; Roche Diagnostics, Mannheim, Germany) and Mc4-TSAb (thyroid-stimulating immunoglobulin, TSI) was measured by the Thyretain™ TSI reporter BioAssay (Diagnostic Hybrids Inc., Athens, OH, USA). The antibody test was defined as positive when TRAb levels were higher than 1.75 IU/L and Mc4-TSAb was higher than the standard value of the sample ratio of 140%. Concentrations of thyroglobulin antibody (normal range, 0–130.6 IU/mL) and thyroperoxidase antibody (normal range, 0–13.7 IU/mL) as a thyroid autoantibody were measured by electrochemiluminescence immunoassay (Roche Diagnostics, Mannheim, Germany).

As part of the FROG-ICU study protocol, each patient had plasma samples collected at inclusion. These prospectively collected samples were used to determine baseline IL-6 (Elecsys COBAS—Roche Diagnostics, Penzberg, Switzerland) and CRP (Architect c—Abbott, Chicago, USA) concentrations in a central laboratory.