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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Hypothyroidism

Treatments: Device: Qualitative POC TSH Kit; Device: Quantitative POC TSH Kit; Device: Third generation TSH Kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT01921452

EMR 200125_507

Details and patient eligibility

About

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.

Enrollment: 283 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

283 participants in 1 patient group

POC TSH Kits + Third Generation TSH Kit

Experimental group

Treatment:

Device: Third generation TSH Kit

Device: Quantitative POC TSH Kit

Device: Qualitative POC TSH Kit