MedTrace Logo

VioOne HIV Profile Supplemental Assay

NCT03727932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 757

Last updated 2018-11-02

No results posted yet for this study

Summary

Assessment of the sensitivity, specificity and reproducibility of the VioOne HIV Profile Supplemental Assay

Conditions

  • HIV Infections

Interventions

DEVICE

VioOne HIV Profile Supplemental Assay

The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of Human Immunodeficiency Virus Type 1 (HIV-1 Group M \& Group O) and Type 2 (HIV-2) in human serum or plasma. The HIV Profile™ is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2.

Sponsors & Collaborators

  • Clinical Reference Laboratory

    collaborator INDUSTRY

  • Duke Clinical Research Institute

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • Avioq, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2018-04-11
Completion
2018-04-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727932 on ClinicalTrials.gov