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Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism

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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.

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Acknowledgments

Sponsorship and article processing charges for this study were funded by Merck Serono Co., Ltd., Beijing, China, an affiliate of Merck KGaA, Darmstadt, Germany. Merck Serono Co., Ltd., was also responsible for protocol development, data management and analysis, and manuscript reviewing. The authors would like to thank the physicians from Shanghai 6th People’s Hospital and staff members from Merck Serono Co., Ltd., who contributed greatly to this study. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.

Disclosures

Tingting Wang has no conflicts of interest or financial ties to disclose. Shiwei Sheng has no conflicts of interest or financial ties to disclose. Meifang Ruan is an employee of Merck Serono Co., Ltd., Beijing, China, an affiliate of Merck KGaA, Darmstadt, Germany. Jing Yan is an employee of Merck Serono Co., Ltd., Beijing, China, an affiliate of Merck KGaA, Darmstadt, Germany. Jianying Gu has no conflicts of interest or financial ties to disclose. Yumin Jiang has no conflicts of interest or financial ties to disclose. Yunchao Gao has no conflicts of interest or financial ties to disclose. Hankui Lu has no conflicts of interest or financial ties to disclose.

Compliance with Ethics Guidelines

This study was registered at ClinicalTrials.gov, under identification no. NCT01921452. The study protocol was approved by the Committees on Ethics and Research Protocols of Shanghai Jiaotong University Affiliated Sixth People’s Hospital. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. All subjects provided voluntary written informed consent prior to performing trial-related activities.

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Authors and Affiliations

  1. Department of Nuclear Medicine, Shanghai Jiaotong University, Affiliated Sixth People’s Hospital, Shanghai, China

    Tingting Wang, Shiwei Sheng, Jianying Gu, Yumin Jiang, Yunchao Gao & Hankui Lu

  2. Department of Medical Affair, Merck Serono Co., Ltd. (an Affiliate of Merck KGaA, Darmstadt, Germany), Beijing, China

    Meifang Ruan & Jing Yan

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  1. Tingting Wang
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Correspondence to Hankui Lu.

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Wang, T., Sheng, S., Ruan, M. et al. Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism. Adv Ther 33, 2001–2011 (2016). https://doi.org/10.1007/s12325-016-0401-y

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