Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism. Issue 11 (November 2016)

• Record Type: Journal Article
• Authors: Wang, Tingting; Sheng, Shiwei; Ruan, Meifang; Yan, Jing; Gu, Jianying; Jiang, Yumin; Gao, Yunchao; Lu, Hankui
• Is Part Of: Advances in therapy. Volume 33:Issue 11(2016)
• Page Start: 2001
• Page End: 2011
• Publication Date: 2016-11
• Subjects: Hypothyroidism -- Immune colloidal gold -- Thyroid-stimulating hormone -- Thyrotropin; Diagnosis -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1007/s12325-016-0401-y
• Languages: English
• ISSNs: 0741-238X

Abstract

Abstract Introduction The immune colloidal gold (ICG) method of measuring thyroid-stimulating hormone (TSH) is a rapid and easy-to-perform test, allowing off-site measurements. This study compared the clinical utility of the first ICG-based qualitative and quantitative TSH test methods in China with the third-generation serum TSH assay used worldwide. Methods Fingertip and venous blood was collected within 30 min from 283 patients initially suspected of hypothyroidism. TSH was measured in fingertip blood using ICG-based qualitative quantitative tests. Serum TSH in venous blood was tested using the third-generation serum TSH assay. Correlations between systems were tested by kappa or Spearman correlation coefficients. Results Compared with the third-generation serum TSH assay, the ICG-qualitative TSH test kit had a kappa coefficient of 0.86, a sensitivity of 85.00%, and a specificity of 99.38% in screening for hypothyroidism. The percentages of false negatives and false positives among all subjects were 6.38% and 0.35% respectively; the total consistency rate of the two methods was 93.26%. When compared with the third-generation serum TSH assay, the ICG-quantitative TSH analysis system had a Spearman correlation coefficient of 0.91, a sensitivity of 88.43%, and a specificity of 98.77%. The percentages of false negatives and false positives among all subjects were 4.95% and 0.71%, respectively; the total consistency rate of the two methods was 94.35%. Conclusion Both ICG-based assays are easier and faster to perform than the third-generation, laboratory-based serum TSH assay method. The ICG-based methods showed acceptable performance in the simplified screening for hypothyroidism. Trial registration ClinicalTrials.gov identifier, NCT01921452. Funding Merck Serono Co., Ltd.