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
|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)|
|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|
|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.
- Number of Participants With Positive and Negative TSH Test Result [ Time Frame: Day 1 up to Day 5 ]
- Concentration of TSH in Whole Blood [ Time Frame: Day 1 up to Day 5 ]
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
|Study Director:||Medical Responsible||Merck Serono Co. Ltd. an affiliate of Merck KGaA, Darmstadt, Germany|