New ALPCO blood tests to detect syphilis antibodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.