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New rapid mpox tests could speed up diagnosis in remote areas

NCT ID NCT07620600

Diagnosis Sponsor: Foundation for Innovative New Diagnostics, Switzerland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 2 times

Summary

This study will check how well three new rapid tests detect mpox virus compared to a standard lab test. Researchers will use about 80 stored skin swab samples from Uganda. The goal is to see if these quick, portable tests are accurate enough for use in places without full labs.

What this could mean

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

What this could lead to
If successful, this could lead to faster, more accessible mpox testing in areas with limited lab resources, helping control outbreaks.
What could go wrong
This is a small, retrospective study using stored samples, not a real-world test. The tests may not perform as well in actual outbreak conditions.

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

80 people

The number who actually took part.

Started

Jun 2026

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The study population consists of archived skin lesion swabs specimens. These were previously collected from individuals suspected of mpox infection - confirmed by PCR as MPXV positive or negative - under research studies and/or public health surveillance protocols during past and ongoing mpox outbreaks and available in the selected clinical sites.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * Lesion swabs stored in VTM/UTM (non-inactivating) * Aliquot with sufficient volume to run the reference PCR and at least one index test (≥2600 μL per pair reference-index tests: ideally at least 1400 μL for 3 index tests and 1200 μL for reference PCR, including 1 possible repeat per test) * Available PCR result for specimen selection (i.e. confirmed MPXV positive or negative) * Samples collected from 2020 onwards. Exclusion Criteria: * Unknown date of collection * \>3 freeze-thaw cycles of sample. * Samples collected with expired swab collection devices or UTM/VTM

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Conditions

The condition(s) this trial relates to.

monkeypox

As listed by the trial registrant

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

Monkey pox

Contacts and locations

Locations

  • National Health Laboratory Services, Central Public Health Laboratory

    Kampala, Buganda Region, Uganda

More trials for these conditions

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