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To evaluate the clinical performance of thyroid stimulating hormone (TSH) test kit

Clinical Performance Evaluation of a Thyroid Stimulating Hormone (TSH) test kit for Point of care settings - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/064457
Enrollment
300
Registered
2024-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Vidcare Innovations Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults advised for TSH testing who gives informed consent would be included.

Exclusion criteria

Exclusion criteria: a. Patients not advised for TSH testing. b. Patients who refuse to participate or provide informed consent.

Design outcomes

Primary

MeasureTime frame
Outcome Name: TSH LEVELSTimepoint: Time-point: Baseline—

Secondary

MeasureTime frame
Outcome Name: TSH LEVELSTimepoint: Time-point: NIL For the clinical trial of the single-use IVD test kit for Hypothyroidism. Since the test kit is designed for single-use only, there wont be any secondary outcomes. Additionally, we will compare the results obtained from the test kit with those from the Chemiluminescent Immunoassay system, assessing the clinical agreement between them.—

Countries

India

Contacts

Public ContactMr Rohan Aggarwal

All India Institute of Medical Science

sudip.datta@aiims.edu01126594629

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026