An observational study in Healthy Volunteers, Syphilis Serologic Assay Development and Blood Specimen Collection, sponsored by American Laboratory Products Company. Enrolling by invitation at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by American Laboratory Products Company · Observational
This prospective, single-center study will collect blood from approximately 50 adult volunteers aged 22 years or older. Participants will provide informed consent, complete an eligibility review, and undergo one blood draw of approximately 20-50 mL.
The blood will be processed into serum and labeled with a study identification number. The serum may be used to prepare laboratory samples with defined antibody levels to support the development and performance evaluation of the ALPCO Syphilis-T and Syphilis-NT assays. All testing is for research purposes only. Individual test results will not be provided to participants or used for diagnosis or treatment.
Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. Laboratory diagnosis commonly includes treponemal tests, which detect antibodies specific to T. pallidum, and non-treponemal tests, which detect antibodies associated with cellular damage and may help assess disease activity.
Serum collected under this study will serve as a human serum matrix for preparing contrived specimens. These specimens may be created by adding characterized reactive serum or other appropriately characterized materials to produce predefined levels of treponemal or non-treponemal reactivity. Before use, the serum may be evaluated using appropriate reference or comparator methods to confirm its suitability.
The resulting specimens will support analytical and, when scientifically and regulatorily appropriate, clinical performance evaluations of the ALPCO Syphilis-T and Syphilis-NT assays. The specific preparation procedures, target reactivity levels, testing methods, and acceptance criteria will be defined in the applicable performance-study protocols.
American Laboratory Products Company is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult volunteers will be recruited at ALPCO in Salem, New Hampshire. The study population will include individuals aged 22 years or older who can safely undergo a single venipuncture for the collection of blood to be processed into serum for research use.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult volunteers aged 22 years or older who provide one blood sample for serum collection and research use.
Device: ALPCO Syphilis-T · Device: ALPCO Syphilis-NT CLIA Kits
Approximately 20-50 mL of whole blood will be collected during one study visit by qualified personnel using standard venipuncture procedures. The blood will be processed to obtain serum for research use in developing and evaluating the ALPCO Syphilis-T and Syphilis-NT assays.
Detection of antibodies to lipoidal antigens in human serum and plasma
Number of Blood Specimens Successfully Processed Into Serum
The number of enrolled participants from whom approximately 20-50 mL of whole blood is successfully collected and processed into serum suitable for research use in the development and performance evaluation of the ALPCO Syphilis-T and Syphilis-NT assays.
Time frame: Day 1, following the single study visit and serum processing
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
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Treponemal Infections
American Laboratory Products Company