Clinical Evaluation of the QuantiFERON CMV Assay

QIAGEN Gaithersburg, Inc8 enrolled

Overview

Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.

Study Type

OBSERVATIONAL

Enrollment

Conditions

CMV

Interventions

QuantiFERON CMV AssayDEVICE

Assay to measure cell-mediated immune function using QuantiFERON CMV assay.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older. * Scheduled to receive between 3 to 6 months of antiviral prophylaxis * Provide Informed Consent Exclusion Criteria: * Subjects less than 18 years old * Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis * Unable to provide Informed Consent

Locations (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in time to CMV Infection between sub-groups of QF-CMV assay classifications.

Measurement of QF-CMV result

Time frame: At time of prophylaxis termination, +1 month from termination, +2 months from termination

Data from ClinicalTrials.gov

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