Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients

Qiagen

Status: Terminated

Conditions: Cell-mediated Immune Response

Treatments: Device: QuantiFERON Monitor Assay; Device: Existing methodology

Study type: Observational

Funder types: Industry

Identifiers

NCT02416414

CST007_10

Details and patient eligibility

About

To compare the performance of the QuantiFERON Monitor assay against existing methodology.

Enrollment: 166 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Solid Organ Transplant Recipient

Inclusion Criteria:

• Provide Informed Consent
• Received a solid organ transplant

Exclusion Criteria:

• Pregnancy or recent lactation (<1yr)
• Treatment of Rejection

Healthy Control

Inclusion Criteria:

• Provide Informed Consent

Exclusion Criteria:

• Currently taking any immunomodulatory medication
• A history of immunosuppressive disease or immunosuppression condition or history of autoimmune diseases
• Current pregnancy or recent lactation (<1yr)
• Currently taking antiviral medication
• Currently being treated for infectious diseases

Trial design

166 participants in 2 patient groups

Solid Organ Transplant Recipients

Description:

Subjects who have received a Solid Organ Transplant.

Treatment:

Device: Existing methodology

Device: QuantiFERON Monitor Assay

Healthy Controls

Description:

Healthy individuals.

Treatment:

Device: Existing methodology

Device: QuantiFERON Monitor Assay