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.

NCT07089836 | Recruiting FDA Device

• 1 other identifier: CPSP-2025-020
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief 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 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.

Conditions

Treponema Pallidum; Serum; Treponema Pallidum Infection; Syphilis Infection; Plasma; Blooddraw; Sexually Transmitted Infection (STI)

Keywords

Non Treponema; Treponema; Syphilis; Sample Collection; Treponema pallidum; Non-treponemal test; Chemiluminescent immunoassay; HIV-positive; Pregnant women; Blood sample collection

Outcome Measures

Primary Outcomes (1)

• 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%.

  6 months

Study Arms (4)

Syphilis-Positive Patients

Individuals with a current or prior diagnosis of syphilis.

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).

Device: ALPCO Syphilis-T; Device: ALPCO Syphilis-NT CLIA Kits

Pregnant Individuals

Pregnant participants across all trimesters.

Device: ALPCO Syphilis-T; Device: ALPCO Syphilis-NT CLIA Kits

Apparently Healthy Individuals

Participants with no known history or symptoms of syphilis.

Device: ALPCO Syphilis-T; Device: ALPCO Syphilis-NT CLIA Kits

Interventions

ALPCO Syphilis-T DEVICE

Detection of antibodies to Treponema pallidum in human serum and plasma

Apparently Healthy Individuals; HIV-Positive Patients; Pregnant Individuals; Syphilis-Positive Patients

ALPCO Syphilis-NT CLIA Kits DEVICE

Detection of antibodies to lipoidal antigens in human serum and plasma

Apparently Healthy Individuals; HIV-Positive Patients; Pregnant Individuals; Syphilis-Positive Patients

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Laboratory Products Company: lead

Study Sites (6)

Chemidox Clinical Trials California

Lancaster, California, 93534, United States

RECRUITING

Folio Clinical Research

Los Angeles, California, 90036, United States

RECRUITING

Segel Trials

North Miami, Florida, 33161, United States

RECRUITING

IMA Clinical Research - St.Petersburg

St. Petersburg, Florida, 33704, United States

RECRUITING

Chemidox Tx LLC

Houston, Texas, 77071, United States

RECRUITING

VAST Clinical Research

Mesquite, Texas, 75149, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples will be collected from participants via venipuncture. These samples will be used to evaluate the performance of the investigational syphilis diagnostic assays. Retained biospecimens will not be used for DNA extraction and will be stored under appropriate conditions for future diagnostic validation studies.

MeSH Terms

Conditions

Treponemal Infections; Syphilis; Sexually Transmitted Diseases; HIV Seropositivity

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Yomi Ojutalayo

CONTACT

800-592-5726; clinops@alpco.com

Jim Richard

CONTACT

800-592-5726; regulatory@alpco.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 28, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)