Xpert Tropical Fever test: Detection and identification of nucleic acids from multiple fever-causing pathogens.
Study summary
This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.
Eligibility
Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Presents with AFI as defined for endemic populations or fever as defined in non-endemic populations or presents with fever as defined for nonendemic populations
* Clinical suspicion of disease caused by at least one of the following: Plasmodium spp, dengue virus, Zika virus, chikungunya virus, or Leptospira (endemic population)
* History of residence in or travel to an endemic geographic region within 3 months prior to specimen collection (endemic population)
Exclusion Criteria:
* Self-reported or known antibiotic or antimalarial use (oral or intravenous) within 3 days prior to enrollment (endemic and nonendemic population)
* History of residence in or trael to endemic geographic region as defined by protocol ≤ three months prior to specimen collection (nonendemic population)
* Clinical suspicion of infection caused by any of the following: Plasmodium spp., dengue virus, Zika virus, chikungunya virus, or Leptospira spp. (nonendemic population)
Primary outcome measure(s)
Clinical performance [PPA and NPA] of Xpert Tropical Fever — Clinical performance on specimens collected at Baseline (Day 0) Evaluating the PPA and NPA of Xpert Tropical Fever relative to the comparator(s)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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