NCT01921452View on ClinicalTrials.gov

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

PHASE4CompletedINTERVENTIONAL
Enrollment

283

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Hypothyroidism
Interventions
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.

Trial Locations (1)

Unknown

Research site, Shanghai

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

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 | Biotech Hunter | Biotech Hunter