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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hypothyroidism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-08-13
• Last updated: 2014-11-25
• Results posted: 2014-11-25

Locations

1 site across 1 country: China