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New blood test could speed up hemorrhagic fever diagnosis

NCT ID NCT07370454

Diagnosis Sponsor: Cepheid Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new diagnostic tool called the Xpert Hemorrhagic Fever test, which looks for genetic material from viruses that cause hemorrhagic fever in blood samples. Researchers used 408 blood samples from donors across the United States, some with fever and some without, to see how well the test could identify infected samples. The goal was to see if the test is accurate enough to be used in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xpert Hemorrhagic Fever test (a diagnostic test that detects viral RNA from blood samples)
What this could lead to
If successful, this test could provide a fast, accurate way to diagnose hemorrhagic fevers, helping doctors identify and respond to outbreaks more quickly.
What could go wrong
This is a completed observational study using stored blood samples, not a real-world outbreak setting. The test's performance in actual patients with active disease may differ.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

408 people

The number who actually took part.

Started

Jan 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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

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Conditions

The condition(s) this trial relates to.

hemorrhagic fever viral hemorrhagic fever

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhagic fever

Contacts and locations

Locations

  • USAMRIID

    Frederick, Maryland, 21702, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.