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The Establishing and Verification of Industry Standard for Thyroid-stimulating Hormone Quantitative Immunoassay Kit

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  • (National Institutes for Food and Drug Control, Beijing 100050, China)

Received date: 2015-03-18

  Revised date: 2015-04-27

  Online published: 2015-07-13

Abstract

Abstract: Objective To establish and verify the industry standard for Thyroid-Stimulating Hormone (TSH) quantitative immunoassay kit. Methods Three types of TSH immunoassay kits of including enzyme, chemiluminescent and time resolved fluorescence labeled immunoassay were used. The appearance and physical examination, the minimum detectable amount, accuracy, linearity, precision, value of quality control, specificity, and stability of immunoassay kits were verified in accordance with industry standard. Results Except the enzyme kit couldn’t meet the demand of linearity range, the others kits could meet all requirements. Conclusion The establishing of the industry standard for Thyroid-Stimulating Hormone quantitative immunoassay kit was reasonable and operable, which would help contribute to the unity Thyroid-Stimulating Hormone quantitative immunoassay kit’s quality, and offer the basis for the administration of its production, examination, circulation, clinical application and other areas.

Cite this article

HUANG Ying, YU Ting, LI Li-li, GAO Shang-xian . The Establishing and Verification of Industry Standard for Thyroid-stimulating Hormone Quantitative Immunoassay Kit[J]. Labeled Immunoassays and Clinical Medicine, 2015 , 22(5) : 453 . DOI: 10.11748/bjmy.issn.1006-1703.2015.05.027

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