Evaluation of the Performance of TSH Rapid Test Cassette for Qualitative of Thyroid-Stimulating Hormone in Whole Blood (for Self-Testing)

The TSH Rapid Test Cassette is a chromatographic immunoassay specifically designed for the qualitative detection of thyroid-stimulating hormone (TSH) in human whole blood, with a designated cut-off concentration of 5 μIU/mL. This study aimed to systematically evaluate the performance characteristics of the test, focusing on sensitivity, specificity, accuracy, and its suitability for self-testing. To achieve this, we compared the TSH Rapid Test Cassette with the Foresight (ACON) TSH ELISA test kit, a widely recognized reference method. A total of 220 whole blood specimens were analyzed, including 54 samples with TSH levels exceeding 5 μIU/mL (positive) and 166 samples with TSH levels below this threshold (negative), taken from individuals suspected of having thyroid dysfunction. The results demonstrated a high relative sensitivity of 98.1% (95% CI: 90.1%-99.9%) and a relative specificity of 98.2% (95% CI: 94.8%-99.6%), resulting in an overall accuracy of 98.2% (95% CI: 95.4%-99.5%). Furthermore, the test exhibited reliable performance with no significant cross-reactivity with common interfering substances, and both intra-assay and inter-assay precision were found to be satisfactory. The user-friendly design, characterized by straightforward operation and a short detection time, underscores its potential for self-testing applications. These findings collectively indicate that the TSH Rapid Test Cassette is a reliable, rapid, and practical tool for the qualitative assessment of TSH in whole blood, making it suitable for point-of-care and home-based screening applications.