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

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ClinicalTrials.gov Identifier: NCT01921452
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypothyroidism Device: Quantitative POC TSH Kit Device: Qualitative POC TSH Kit Device: Third generation TSH Kit Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : October 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Arm Intervention/treatment
Experimental: POC TSH Kits + Third Generation TSH Kit Device: Quantitative POC TSH Kit
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.

Device: Qualitative POC TSH Kit
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.

Device: Third generation TSH Kit
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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921452


Locations
China
Research site
Shanghai, China
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible Merck Serono Co. Ltd. an affiliate of Merck KGaA, Darmstadt, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01921452     History of Changes
Other Study ID Numbers: EMR 200125_507
First Posted: August 13, 2013    Key Record Dates
Results First Posted: November 25, 2014
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Merck KGaA:
Hypothyroidism
Third generation TSH kit
Quantitative POC TSH kit
Qualitative POC TSH kit

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases