New ALPCO blood tests to detect syphilis antibodies
ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma
This will test two ALPCO blood tests that look for treponemal and non-treponemal antibodies in people screened for or suspected of having syphilis, including pregnant and HIV-positive individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | American Laboratory Products Company Industry-sponsored |
| Locations | 6 sites (Lancaster, California and 5 other locations) |
| Trial ID | NCT07089836 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective specimen-collection effort will collect blood from people undergoing routine syphilis testing, those at high risk, people living with HIV, pregnant individuals, and healthy volunteers. Samples will be run on the automated KleeYa platform using the ALPCO Syphilis-T (treponemal) and Syphilis-NT (non-treponemal) CLIA kits. Results from the investigational kits will be compared to validated, FDA‑cleared treponemal and non‑treponemal reference assays to determine agreement. The primary goals are to measure positive and negative percent agreement and demonstrate the kits meet prespecified performance thresholds.
Who should consider this trial
Good fit: Ideal candidates are people aged 13 and older who are undergoing or consenting to routine syphilis testing, including pregnant individuals, people living with HIV, those with suspected infection, and healthy volunteers willing to give blood.
Not a fit: People who cannot provide blood, need immediate diagnostic results for treatment decisions, or are in the very early window period before antibodies form are unlikely to get direct clinical benefit from participation.
Why it matters
Potential benefit: If the kits meet performance targets, they could provide faster, automated, and reliable detection of syphilis antibodies to improve screening and diagnosis, especially in pregnant and HIV-positive patients.
How similar studies have performed: Comparable treponemal and non-treponemal immunoassays on automated platforms are widely used and have generally shown good performance, though these specific ALPCO kits are being prospectively validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lancaster, California and 5 other locations
- Chemidox Clinical Trials California — Lancaster, California, United States (Recruiting)
- Folio Clinical Research — Los Angeles, California, United States (Recruiting)
- Segel Trials — North Miami, Florida, United States (Recruiting)
- IMA Clinical Research - St.Petersburg — St. Petersburg, Florida, United States (Recruiting)
- Chemidox Tx LLC — Houston, Texas, United States (Recruiting)
- VAST Clinical Research — Mesquite, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Yomi Ojutalayo
- Email: clinops@alpco.com
- Phone: 800-592-5726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.