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  4. Vol 6, Issue 3, 2025

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

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DOI: 10.23977/medsc.2025.060314 | Downloads: 2 | Views: 141

Author(s)

Lei Zhang 1, Feng Yang 2, Junzhe Zhu 3

Affiliation(s)

1 Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
2 Community Health Service Center, Hangzhou, Zhejiang, 310000, China
3 Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Lei Zhang

ABSTRACT

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.

KEYWORDS

TSH; Rapid Test Cassette; Chromatographic Immunoassay; ELISA; Self-Testing; Thyroid Disorders

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu, Evaluation of the Performance of TSH Rapid Test Cassette for Qualitative of Thyroid-Stimulating Hormone in Whole Blood (for Self-Testing). MEDS Clinical Medicine (2025) Vol. 6: 89-93. DOI: http://dx.doi.org/10.23977/medsc.2025.060314.

REFERENCES

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[2] Brent GA. Clinical practice. Hypothyroidism. N Engl J Med. 2008;358(19):203-211.
[3] Van Herck E, et al. Analytical performance of a new automated TSH assay. Clin Chem Lab Med. 2002; 40(11): 1154-1158.
[4] O'Farrell N, O'Kennedy R. Lateral flow immunoassays for infectious diseases: a review. Anal Bioanal Chem. 2009; 393(3): 669-682.
[5] Hollowell JG, Staehling NW, Flanders WD, et al. Serum TSH, T(4), and thyroid antibodies in the United States population (1988-1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002; 87(2):489-499.
[6] Rehman A, et al. Evaluation of ELISA for the detection of thyroid stimulating hormone (TSH) in serum. J Ayub Med Coll Abbottabad. 2012;24(4):71-73.

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