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CompletedNCT05831098Updated Jan 26, 2026

Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT

An interventional study of Reveal TP (Syphilis) Antibody Test in Syphilis Infection, Syphilis and Early Syphilis, Symptomatic, sponsored by MedMira Laboratories Inc.. Completed at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by MedMira Laboratories Inc. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).

Read the detailed description

This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).

The healthcare professional will advise patients about the study, and with their permission refer them to research staff for recruitment. Should patients choose to participate in the study they will be asked to provide consent to have a few drops of blood sample obtained through a finger prick to be used in the POCT. POCT results will not be provided to participants and this will be explained in both the recruitment script and informed consent form. A sample of 5 to 10 ml venous whole blood will also be obtained for the conventional syphilis serology testing which is part of the routine for care of the four categories of patients (regardless of this research). This research will take approximately 15 to 30 minutes and will be on top of the regular care that patients will receive in the clinic. Upon completing the tests, participants will be asked to complete a brief feedback survey to assess patients' acceptability of syphilis POCT.

02

Conditions studied

  • Syphilis Infection
  • Syphilis
  • Early Syphilis, Symptomatic

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Keywords

  • Rapid Vertical Flow (RVF)
  • Reveal TP
  • Syphilis
  • POCT
  • MedMira
03

In context

Syphilis

126 studies on the registry are indexed under Syphilis; 34 are open to participants now.

This study's enrollment of 600 is above the median of 354 across 85 interventional studies indexed under Syphilis.

Browse Syphilis studies →

Lead sponsor

MedMira Laboratories Inc. is the lead sponsor of 4 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
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients 19 years of age and above attending the BCCDC STI Clinic in Vancouver, British Columbia for routine sexual health care and requiring syphilis testing as part of this care are eligible for this study.

    • Additionally, for each participant category:

      • Group 1: No known (i.e. self-reported or laboratory documented history of syphilis) prior history of syphilis.
      • Group 2: No additional inclusion criteria
      • Group 3: Participants were named as a contact by a confirmed syphilis case within the last year, and have not yet received treatment
      • Group 4: No additional inclusion criteria
    • Those who had other STIs in the past or being suspected of having other STIs are not excluded as long as testing for syphilis is part of the care provided to them. Once it has been determined that the exclusion criteria does not apply to a patient, the recruitment of the four categories of participants will be offered without other pre-selection criteria unless there may be other unforeseeable circumstances arising, such as shortage of clinic staff or large number of patients showing up.

Exclusion criteria

Exclusion Criteria:

    • Minors, and those who, at the discretion of the health care provider/research co-ordinator, appear intoxicated and/or with extreme distress, or confused, will be excluded from this research because they would not be able to provide to participate.

      • Additionally, for each participant category:

        • Group 1: Current symptoms that could be consistent with early syphilis.
        • Group 2: No additional exclusion criteria
        • Group 3: Current symptoms that could be consistent with early syphilis.
        • Group 4: Current symptoms that could be consistent with early syphilis.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test

    Participants are tested with investigational devices and conventional syphilis serology tests.

    Device: Reveal TP (Syphilis) Antibody Test

Interventions

  • DeviceReveal TP (Syphilis) Antibody Test

    All subjects tested with both investigational devices and conventional syphilis serology tests.

    Also known as: Reveal TP

06

What researchers measure

Primary outcomes

  1. To determine the accuracy of Reveal TP (Syphilis) Antibody Test

    For each enrolled subject, Reveal TP (Syphilis) Antibody Test will be used to test fingerstick whole blood from the patient. A venipuncture whole blood sample will also be drawn from the patient and will be tested using conventional serological testing methods to determine patient status.

    Time frame: 1 patient visit of approximately 30 minutes

07

Study locations

1 site
  • BCCDC STI Clinic
    Vancouver, British Columbia V5Z 4R4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Dec 2024, 18 months.

Of 25 interventional studies with no phase under Syphilis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2023
First posted
Apr 26, 2023
StartActual
May 12, 2023
Primary completionActual
Dec 6, 2024
CompletionActual
Dec 6, 2024
Last update
Jan 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05831098
Lead sponsor
MedMira Laboratories Inc.
Collaborators
Public Health Agency of Canada (PHAC)
Responsible party
Sponsor
First posted
Apr 26, 2023
Start date
May 12, 2023
Primary completion
Dec 6, 2024
Completion
Dec 6, 2024
Last update
Jan 26, 2026

Study contacts

Troy Grennan, Dr
principal investigator · British Columbia Center for Disease Control (BCCDC)
Raymond Tsang, Dr
principal investigator · National Microbiology Laboratory Branch, Public Health Agency of Canada

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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