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89.3%; specificity, 0.05, 96.0% vs. no correlation was found between TSI and tri-iodothyronine or free thyroxine. Conclusions The Mc4-CHO bioassay showed comparable diagnostic value for GD with the conventional TBII assay. We propose a cut-off of 123.0 SRR% in areas where iodine intake is high. tests. Differences between categorical variables within groups were tested with the chi-square test or Fisher’s exact test, as appropriate. Correlation analyses were performed using Spearman’s CO-1686 (Rociletinib, AVL-301) rank correlation coefficient. A receiver operating characteristic (ROC) curve analysis was performed to obtain the optimal cut-off for positivity in the Mc4-TSI bioassay. The sensitivity and specificity were estimated from the ROC curves. A value 0.05 was considered statistically significant. RESULTS Diagnostic value of the Mc4-TSI bioassay The intra-assay CVs were 3.0% for the high-positive control set (496 SRR%), 5.0% for the medium-positive control set (212 SRR%), 4.4% for CO-1686 (Rociletinib, AVL-301) the low-positive control set (144 SRR%), and 6.8% for the negative control set (41 SRR%), with mean TSI values of 496, 212, 144, and 41%, respectively. The inter-assay CVs were 10.8, 7.0, 6.6, and 19.5% with mean TSI values of 444, 199, 141, and 36 SRR%, respectively (Fig. 1). To obtain the optimal decision threshold level for diagnosing GD, an ROC analysis was performed on 67 patients with untreated GD and on 74 patients with Hashimoto’s thyroiditis, subacute thyroiditis, Rabbit Polyclonal to CDCA7 or painless/postpartum thyroiditis. The area under the curve for the Mc4-CHO bioassay was 0.97 (95% confidence interval, 0.94 to 1 1.00), and the optimal cut-off was set at 123.0 SSR% with 97.0% sensitivity and 95.9% specificity for diagnosing GD (Fig. 2). Open in a separate window Physique 1 The intra-assay (A) and inter-assay (B) coefficient of variation (CV) for precision in the high-positive, medium-positive, low-positive, and unfavorable control sets. Open in a separate window Physique 2 Receiver operating curve analysis of Mc4 thyroid-stimulating hormone receptor and thyroid-stimulating immunoglobulin data from 141 patients (67 with untreated Graves’ disease, 42 with Hashimoto’s thyroiditis, 12 with subacute thyroiditis, and 20 with painless/postpartum thyroiditis patients). Serum TSI measurements in each study group The distributions of serum TSI levels in each study group, as measured by the Mc4-TSI bioassay, are shown in Fig 3. Open in a separate window Physique 3 Distribution of serum Mc4 thyroid-stimulating hormone receptor (TSHR) and thyroid-stimulating immunoglobulin (TSI) values in each study group. The mean TSIs of each group of patients with Graves’ disease (GD) (untreated, in treatment, and in remission) CO-1686 (Rociletinib, AVL-301) were significantly higher than those with Hashimoto’s thyroiditis, subacute thyroiditis, postpartum/painless thyroiditis, and healthy euthyroid controls ( 0.01). The line for each group indicates the mean value. The dotted line represents the cut-off value of 123.0 specimen-to-reference ratio percentage (SRR%). Of 67 untreated patients with GD, 65 (97.0%) had positive TSI bioassay results. In contrast, of 42 patients with Hashimoto’s thyroiditis, only 1 1 (2.4%) had a positive result, while of 20 patients CO-1686 (Rociletinib, AVL-301) with painless/postpartum thyroiditis, 2 (10%) tested positive using the new bioassay. All patients with subacute thyroiditis (n = 12) had negative results around the Mc4-TSI bioassay. None of the euthyroid healthy controls (n = 93) were positive using CO-1686 (Rociletinib, AVL-301) the new TSI bioassay. The TSI values (mean and SD) measured by the Mc4-CHO bioassay for patients with untreated GD, GD under treatment, GD in remission, Hashimoto’s thyroiditis, subacute thyroiditis, postpartum/painless thyroiditis, and euthyroid healthy.