Xpert Hemorrhagic Fever on Edge X in Trained and Untrained Users

Conditions

• Hemorrhagic Fever

Eligibility Criteria

Sex

ALL

Age

14 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Xpert Hemorrhagic Fever test — DIAGNOSTIC_TEST
  Detection and identification of RNA from multiple viruses in CWB and VWB from individuals with signs and symptoms of the suspected infections and/or individuals who are at risk for exposure or may have been exposed to these viruses.

Study Details

A multi-site observation study that was conducted in the United States at 3 CLIA Waived sites with Untrained Users testing on Xpert Hemorrhagic fever tests on Edge X instruments

Key Dates

Start date

Oct 21, 2024

Status verified

May 2026

Primary completion

Mar 14, 2025

Completion

Mar 13, 2026

Study Design

Enrollment

725 participants (actual)

Arms

• Arm: CWB and VWB specimens from consented blood donors
  Non-Contrived and Contrived CWB and VWB specimens with pseudoviral constructs from multiple viruses

Primary Outcome Measure

Clinical Performance [PPA and NPA] of Xpert on Edge X in Untrained and Trained Users [ Time Frame: Clinical Performance assessed at Baseline ]

Locations (1)

Find similar trials in Birmingham, AL