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

Abstract

The TSH Rapid Test Cassette is a chromatographic immunoassay designed for qualitative detection of thyroid-stimulating hormone (TSH) in human whole blood, with a cutoff of 5 μIU/mL. This study aimed to systematically evaluate its diagnostic performance—sensitivity, specificity, accuracy, and suitability for self-testing—by comparing it with the Foresight (ACON) TSH ELISA kit, a validated reference method. A total of 220 specimens were tested (54 positive, 166 negative). The test showed 98.1% sensitivity, 98.2% specificity, and 98.2% overall accuracy. No cross-reactivity or interference was observed with common substances, and intra- and inter-assay precision were excellent. Due to its ease of use, short reaction time, and clear results, the TSH Rapid Test Cassette is a reliable, rapid, and practical solution for self-testing and point-of-care thyroid screening.