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Completed

NCT Number: NCT01921452

Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research site

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected hypothyroidism subject
  • Willing to comply with the trial protocol
  • Signed informed consent document

Exclusion criteria

  • Menstrual period, bleeding hemorrhoids, hematuria
  • Drinking or taking aspirin within 48 hours
  • Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
  • Subjects who are unwilling or unable to complete the trial
  • Subjects who do not sign informed consent form

Treatment and study plan

Quantitative POC TSH Kit

Device

A drop (approximately 30 microliter [mcL]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5.

Qualitative POC TSH Kit

Device

A drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5.

Third generation TSH Kit

Device

One milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5.

Primary outcomes

  1. Number of Participants With Positive and Negative TSH Test Result

    Time frame: Day 1 up to Day 5

  2. Concentration of TSH in Whole Blood

    Time frame: Day 1 up to Day 5

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Single-center Interventional Study to Verify Clinical Utility of the Quantitative and the Qualitative POC TSH Test Kits Compared With the Third Generation TSH Test Kit

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2013
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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