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

Hypothyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921452
• Other study ID #: EMR 200125_507
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2013
• Last updated: November 20, 2014
• Start date: October 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Research site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Positive and Negative TSH Test Result		Day 1 up to Day 5	No
Primary	Concentration of TSH in Whole Blood		Day 1 up to Day 5	No