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

First listed

May 18, 2026

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)

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