Clinical Performance Evaluation of DxN CMV Assay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-08-30

Brief Summary

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The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the DxN CMV Assay for plasma samples in the intended use population.

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Detailed Description

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same as brief summary

Conditions

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Cytomegalovirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CMV infected

CMV infected observational study testing using DxN CMV Assay. Study is observational and results not used to manage patient care.

CMV Assay

Intervention Type DIAGNOSTIC_TEST

Molecular diagnostic test to detect CMV

Interventions

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CMV Assay

Molecular diagnostic test to detect CMV

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DxN CMV Assay

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years old
* Must have had a kidney transplant and be evaluated for post-transplantation care
* Must have demonstrated post-transplant CMV DNAemia
* Must be eligible for and treated with anti-CMV drugs