Clinical Performance Evaluation of DxN HBV Assay
NCT03123159 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 60
Last updated 2018-07-12
Summary
The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
DxN HBV Assay
Molecular diagnostic test to detect Hepatitis B
Sponsors & Collaborators
-
Beckman Coulter, Inc.
lead INDUSTRY
Principal Investigators
-
Lori Lofaro, MSHS · Beckman Coulter
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-27
- Primary Completion
- 2017-08-30
- Completion
- 2017-08-30
Countries
- United States
- Canada
Study Locations
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