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CompletedNCT07370454Updated Jan 27, 2026

Xpert® Hemorrhagic Fever on the GeneXpert® Edge X System

An observational study in Hemorrhagic Fever, sponsored by Cepheid. Completed at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Cepheid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
408
Ages
14 Years and older
Sex
All
01

Study summary

A multi-site observation study that was conducted a geographically diverse sites across the United States

Read the detailed description

Capillary and venous whole blood specimens were prospectively collected from consented individuals symptomatic or asymptomatic of fever

02

Conditions studied

  • Hemorrhagic Fever
03

In context

Hemorrhagic Fevers, Viral

76 studies on the registry are indexed under Hemorrhagic Fevers, Viral; 10 are open to participants now.

This study's enrollment of 408 is above the median of 269 across 14 observational studies indexed under Hemorrhagic Fevers, Viral.

Browse Hemorrhagic Fevers, Viral studies →

Lead sponsor

Cepheid is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Whole blood specimens collected from blood donors symptomatic or asymptomatic of fever

Inclusion criteria

  • Capillary and venous whole blood specimens from blood donors who symptomatic for fever lasting ≤ 10 days OR asymptomatic for fever
  • Whole blood specimens collected in EDTA specimens collection devices only

Exclusion criteria

Exclusion Criteria:

  • Any whole blood specimens from blood donors vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days
  • Any whole blood specimen that were previously enrolled
  • Any whole blood specimens not collected according to the manufacturer's instructions
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
408 participants (actual)
Patient registry
No

Groups and cohorts

  • Capillary and venous whole blood specimens

    whole blood specimens from individuals asymptomatic or symptomatic of fever

    Diagnostic Test: Xpert Hemorrhagic Fever test

Interventions

  • Diagnostic testXpert Hemorrhagic Fever test

    Detection and identification of RNA from multiple viruses from whole blood specimens

06

What researchers measure

Primary outcomes

  1. Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens

    Xpert test compared to expected status

    Time frame: Clinical Performance assessed in specimens collected at Baseline

07

Study locations

1 site
  • USAMRIID
    Frederick, Maryland 21702, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07370454
Lead sponsor
Cepheid
Responsible party
Sponsor
First posted
Jan 27, 2026
Start date
Jan 13, 2025
Primary completion
Apr 29, 2025
Completion
Oct 3, 2025
Last update
Jan 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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