Xpert Hemorrhagic Fever on Edge X in Trained and Untrained Users

Cepheid725 enrolled

Overview

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

Capillary and Venous whole blood collected from consented healthy individuals contrived with pseudoviral constructs from multiple viruses and non-contrived were tested by untrained users in a CW environment and trained users in a laboratory setting on the Edge X instrument.

Study Type

OBSERVATIONAL

Enrollment

725

Conditions

Hemorrhagic Fever

Interventions

Xpert Hemorrhagic Fever testDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Capillary and venous whole blood specimens from individuals asymptomatic for fever • Whole blood specimens collected in EDTA specimens collection devices only- Whole Blood specimens collected in EDTA specimen collection devices only Exclusion Criteria: * Participants vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days. * Participant was previously enrolled into this protocol. • VWB and CWB specimens were not collected according to the manufacturer's instructions.

Locations (1)

No-Resistance Consulting Group

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Clinical Performance [PPA and NPA] of Xpert on Edge X in Untrained and Trained Users

Evaluating the PPA and NPA of Xpert compared to expected status of specimens

Time frame: Clinical Performance assessed at Baseline

Data from ClinicalTrials.gov

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