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One fingerstick, three infections: new rapid test under study

NCT ID NCT07569913

Diagnosis Sponsor: bioLytical Laboratories 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a new rapid device called TruPlex that checks for HIV, Hepatitis B, and Syphilis using a single fingerstick blood sample. About 500 adults at risk for these infections will take part. Researchers want to see if the test is accurate and easy for trained staff to use at clinics or point-of-care sites.

What this could mean

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

Active substance
TruPlex HIV/HepB/Syphilis Rapid Test (a rapid diagnostic device using a fingerstick blood sample)
What this could lead to
If successful, this could provide a fast, single-test way to detect three infections at once, making screening easier in clinics and community settings.
What could go wrong
This is an early-stage diagnostic study, not a treatment trial. The test may not be as accurate as current lab methods, and results may not apply to all populations or settings.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

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.

Ages

18 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: * 18 years of age or older * Subject is able to provide and willing to sign and date the Informed Consent Form * Subject is able to complete the required testing on the allocated testing day. * Subject is able to speak/read/write English or a translator is available * Subject is getting tested for HIV, and/or Syphilis, and/or Hepatitis B for one or more of the following reasons: * At risk for any one of the target diseases * Having signs or symptoms indicative of the target diseases * Routine testing * Note: Subjects who are pregnant and re-infected are eligible to participate * Unknown HIV or known HIV positive status with less than 12 months of Anti-Retroviral Treatment (ART). * Subject is willing to provide the fingerstick blood sample(s) and whole blood samples collected through venous blood draw (approximately 16 ml) required for the study. * Subject willing to participate in the study site's standard of care counselling and testing program and receive the study site's standard of care test results Exclusion Criteria: * Subject has a bleeding disorder * Subject is currently undergoing Syphilis treatment * Subject has received any experimental HIV vaccine * Subject received HBV vaccine within the last 7 days * Known HIV positive subjects and currently on ART for 12 months or longer * Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of study assessment, consent form and questionnaire etc. or bias the study outcome.

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection HIV infectious disease syphilis

As listed by the trial registrant

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

Hepatitis B infection HIV 2 infection HIV1 infection Syphilis infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • St Vincent's Hospital (Melbourne), Dept. of Gastroenterology

    Melbourne, Victoria, 3065, Australia

More trials for these conditions

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