Hemorrhagic FeverNCT07591740
Xpert Hemorrhagic Fever on Edge X in Trained and Untrained Users
An observational study of Hemorrhagic Fever, run by Cepheid at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhagic Fever
- What is being tested?
- Xpert Hemorrhagic Fever test
- How many people
- 725 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 13 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Whole blood specimens collected from individuals asymptomatic of fever
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
No-Resistance Consulting Group
Birmingham, Alabama, 35242
About this study
Official title: Comparison Study of the Xpert Hemorrhagic Fever Test Between Trained and Untrained Users on the GeneXpert Edge X System
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
Read the detailed description
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.
- Conditions
- Hemorrhagic Fever
- Being tested
- Xpert Hemorrhagic Fever test
- Medical subject headings
- Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| CWB and VWB specimens from consented blood donors | Non-Contrived and Contrived CWB and VWB specimens with pseudoviral constructs from multiple viruses Receives: Diagnostic Test: Xpert Hemorrhagic Fever test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Clinical Performance assessed at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start21 Oct 2024
- Primary completion14 Mar 2025
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591740
- Sponsor's protocol ID
- P259C3
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of the Xpert Hemorrhagic Fever Test Between Trained and Untrained Users on the GeneXpert Edge X System
- ClinicalTrials.gov ID
- NCT07591740
- Acronym / sponsor ID
- P259C3
- Conditions
- Hemorrhagic Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 725 participants (actual)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CWB and VWB specimens from consented blood donors | – | Diagnostic Test: Xpert Hemorrhagic Fever testNon-Contrived and Contrived CWB and VWB specimens with pseudoviral constructs from multiple viruses |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Whole blood specimens collected from individuals asymptomatic of fever
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert Hemorrhagic Fever testDetection 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. | Diagnostic test | CWB and VWB specimens from consented blood donors |
Primary outcome
Clinical Performance [PPA and NPA] of Xpert on Edge X in Untrained and Trained Users
Time frame: Clinical Performance assessed at Baseline
Evaluating the PPA and NPA of Xpert compared to expected status of specimens
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhagic Fever, run by Cepheid at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.