MedTrace Logo

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

NCT01921452 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2014-11-25

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Serono Limited, UK

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01921452 on ClinicalTrials.gov