Xpert® Tropical Fever Test on GeneXpert® Edge X System

Conditions

• Chikungunya Virus Infection
• Dengue Fever
• Leptospirosis
• Malaria Fever
• Zika

Eligibility Criteria

Sex

ALL

Age

14 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Xpert Tropical Fever test — DIAGNOSTIC_TEST
  Detection and identification of nucleic acids from multiple fever-causing pathogens.

Study Details

This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.

Key Dates

Start date

Aug 18, 2025

Status verified

Apr 2026

Primary completion

Aug 31, 2026

Completion

Feb 28, 2027

Study Design

Enrollment

2,500 participants (estimated)

Arms

• Arm: Capillary and venous WB specimens
  WB specimens collected from individuals who present with AFI and have clinical suspicion of infection caused by at least one fever-causing agent

Primary Outcome Measure

Clinical performance [PPA and NPA] of Xpert Tropical Fever [ Time Frame: Clinical performance on specimens collected at Baseline (Day 0) ]

Locations (1)

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