Treponema PallidumNCT07089836
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
An observational study of Treponema Pallidum and Treponema Pallidum Infection, run by American Laboratory Products Company at 6 sites in United States.
Trial summary
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection
- What is being tested?
- ALPCO Syphilis-T and ALPCO Syphilis-NT CLIA Kits
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients suspected of syphilis, at high-risk for syphilis, or scheduled for routine syphilis related serological testing will be enrolled in the clinical study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Chemidox Tx LLC
Houston, Texas, 77071
- Recruiting
Chemidox Clinical Trials California
Lancaster, California, 93534
- Recruiting
Folio Clinical Research
Los Angeles, California, 90036
- Recruiting
VAST Clinical Research
Mesquite, Texas, 75149
- Recruiting
Segel Trials
North Miami, Florida, 33161
- Recruiting
IMA Clinical Research - St.Petersburg
St. Petersburg, Florida, 33704
About this study
Official title: ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the automated KleeYa platform. The study will collect and analyze blood samples from individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The aim is to determine the kits' Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to established reference assays.
Read the detailed description
This is a multicenter, prospective clinical collection study designed to evaluate the diagnostic performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits. The study will enroll individuals undergoing routine syphilis testing, those with a history of syphilis, HIV-positive individuals, pregnant individuals, and healthy volunteers. Blood samples will be collected, processed, and tested across up to three clinical sites using the investigational kits. Reference results will be determined using validated, FDA-cleared treponemal and non-treponemal tests. For the treponemal assay, results will be considered accurate if they match at least two of the three reference tests. The primary objective is to demonstrate that both kits meet or exceed prespecified performance criteria, including ≥95% positive and negative percent agreement (≥99% NPA for the non-treponemal kit), with the lower bound of the 95% confidence interval at or above 90%.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum, Plasma, Blooddraw
- Being tested
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Keywords
- Non Treponema, Treponema, Syphilis, Sample Collection, Treponema pallidum, Non-treponemal test, Chemiluminescent immunoassay, HIV-positive, Pregnant women, Blood sample collection
- Medical subject headings
- Treponemal Infections, Syphilis, Sexually Transmitted Diseases, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPCO Syphilis-TDevice
Detection of antibodies to Treponema pallidum in human serum and plasma
ALPCO Syphilis-NT CLIA KitsDevice
Detection of antibodies to lipoidal antigens in human serum and plasma
| Study group | Role | What they receive |
|---|---|---|
| Syphilis-Positive Patients | Individuals with a current or prior diagnosis of syphilis. Receives: Device: ALPCO Syphilis-T; Device: ALPCO Syphilis-NT CLIA Kits | |
| HIV-Positive Patients | Individuals diagnosed with HIV (may or may not overlap with other cohorts). Receives: Device: ALPCO Syphilis-T; Device: ALPCO Syphilis-NT CLIA Kits | |
| Pregnant Individuals | Pregnant participants across all trimesters. Receives: Device: ALPCO Syphilis-T; Device: ALPCO Syphilis-NT CLIA Kits | |
| Apparently Healthy Individuals | Participants with no known history or symptoms of syphilis. Receives: Device: ALPCO Syphilis-T; Device: ALPCO Syphilis-NT CLIA Kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits
Evaluate the clinical performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits in detecting antibodies to Treponema pallidum and lipoidal antigens, by comparing results against established comparator assays. Success is defined as meeting or exceeding pre-specified thresholds for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), with lower bounds of the 95% confidence interval ≥90%.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start10 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treponema PallidumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Laboratory Products Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089836
- Sponsor's protocol ID
- CPSP-2025-020
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma
- ClinicalTrials.gov ID
- NCT07089836
- Acronym / sponsor ID
- CPSP-2025-020
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum, Plasma, Blooddraw
- Keywords
- Non Treponema, Treponema, Syphilis, Sample Collection, Treponema pallidum, Non-treponemal test, Chemiluminescent immunoassay, HIV-positive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- American Laboratory Products CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the automated KleeYa platform. The study will collect and analyze blood samples from individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The aim is to determine the kits' Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to established reference assays.
Detailed description
This is a multicenter, prospective clinical collection study designed to evaluate the diagnostic performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits. The study will enroll individuals undergoing routine syphilis testing, those with a history of syphilis, HIV-positive individuals, pregnant individuals, and healthy volunteers. Blood samples will be collected, processed, and tested across up to three clinical sites using the investigational kits. Reference results will be determined using validated, FDA-cleared treponemal and non-treponemal tests. For the treponemal assay, results will be considered accurate if they match at least two of the three reference tests. The primary objective is to demonstrate that both kits meet or exceed prespecified performance criteria, including ≥95% positive and negative percent agreement (≥99% NPA for the non-treponemal kit), with the lower bound of the 95% confidence interval at or above 90%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Syphilis-Positive Patients | – | Device: ALPCO Syphilis-T, Device: ALPCO Syphilis-NT CLIA KitsIndividuals with a current or prior diagnosis of syphilis. |
| HIV-Positive Patients | – | Device: ALPCO Syphilis-T, Device: ALPCO Syphilis-NT CLIA KitsIndividuals diagnosed with HIV (may or may not overlap with other cohorts). |
| Pregnant Individuals | – | Device: ALPCO Syphilis-T, Device: ALPCO Syphilis-NT CLIA KitsPregnant participants across all trimesters. |
| Apparently Healthy Individuals | – | Device: ALPCO Syphilis-T, Device: ALPCO Syphilis-NT CLIA KitsParticipants with no known history or symptoms of syphilis. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suspected of syphilis, at high-risk for syphilis, or scheduled for routine syphilis related serological testing will be enrolled in the clinical study.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALPCO Syphilis-TDetection of antibodies to Treponema pallidum in human serum and plasma | Device | Apparently Healthy Individuals, HIV-Positive Patients, Pregnant Individuals, Syphilis-Positive Patients |
| ALPCO Syphilis-NT CLIA KitsDetection of antibodies to lipoidal antigens in human serum and plasma | Device | Apparently Healthy Individuals, HIV-Positive Patients, Pregnant Individuals, Syphilis-Positive Patients |
Primary outcome
Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits
Time frame: 6 months
Evaluate the clinical performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits in detecting antibodies to Treponema pallidum and lipoidal antigens, by comparing results against established comparator assays. Success is defined as meeting or exceeding pre-specified thresholds for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), with lower bounds of the 95% confidence interval ≥90%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treponema Pallidum and Treponema Pallidum Infection, run by American Laboratory Products Company at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yomi Ojutalayo (800-592-5726, clinops@alpco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.