Could new syphilis tests speed up diagnosis?
NCT ID NCT07089836
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 4 times
Summary
This study is testing two new blood test kits designed to diagnose syphilis. Researchers will collect blood samples from 1000 people, including those with symptoms, those at high risk, and healthy controls. The goal is to see how accurate these new kits are compared to standard lab tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ALPCO Syphilis-T and Syphilis-NT CLIA kits (diagnostic devices)
- What this could lead to
- If successful, these kits could provide a faster, automated way to diagnose syphilis, improving detection and treatment.
- What could go wrong
- This is a diagnostic accuracy study, not a treatment trial. The kits may not perform as well as expected, and results may not apply to all populations.
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
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
Patients suspected of syphilis, at high-risk for syphilis, or scheduled for routine syphilis related serological testing will be enrolled in the clinical study.
- Ages
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13 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Male, Female, or Other(s) * Patients undergoing routine syphilis testing (asymptomatic at risk, suspected with symptoms, prior history of syphilis, high risk for syphilis) or previously diagnosed with syphilis through a test performed in an accredited laboratory. * Participants must be willing to provide the required blood samples for the clinical study, in addition to any samples requested by their physician. * Pregnant individuals and children (under 22): 1 clinical study tube of blood. * All other participants (excluding pregnant individuals and children): 2 clinical study tubes of blood. * Participants must be able and willing to sign the informed consent form (ICF). * Participants aged 13 to 17 will be asked to sign an assent form. Written parental or guardian consent will also be required prior to enrollment. The assent form will use age-appropriate language and be reviewed with the participant before any procedures. Exclusion Criteria: * Patients currently being treated with antibiotics or completed a course of antibiotics within the past 30 days * Patients with pre-existing conditions that would make blood collection difficult or harmful * If the samples are not collected in strict accordance with the established sampling protocol, as determined by the study team. * Any medical, psychological, or social condition that, in the judgment of the investigator, could interfere with the participant's ability to comply with study requirements, or pose a risk to their safety, or compromise the integrity of the study.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Chemidox Clinical Trials California
RECRUITINGLancaster, California, 93534, United States
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Chemidox Tx LLC
RECRUITINGHouston, Texas, 77071, United States
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Folio Clinical Research
RECRUITINGLos Angeles, California, 90036, United States
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IMA Clinical Research - St.Petersburg
RECRUITINGSt. Petersburg, Florida, 33704, United States
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Segel Trials
RECRUITINGNorth Miami, Florida, 33161, United States
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VAST Clinical Research
RECRUITINGMesquite, Texas, 75149, United States
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Other studies related to the condition(s) this trial covers.
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- New rapid test could detect three infections at once
- Quick ER test could spot HIV and syphilis in pregnant women, saving babies
- Could a single antibiotic dose after sex stop STIs?
- Can a simple finger-prick test help find hidden HIV and syphilis cases?