Clinical Performance Evaluation of DxN CMV Assay

Beckman Coulter

Status: Terminated

Conditions: Cytomegalovirus

Treatments: Diagnostic Test: CMV Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT03127787

CMV 2.7.3.001

Details and patient eligibility

About

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.

Full description

same as brief summary

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• HIV positive
• Proven ganciclovir or valganciclovir resistance

Trial design

19 participants in 1 patient group

CMV infected

Description:

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

Treatment:

Diagnostic Test: CMV Assay