Healthy VolunteersNCT07830550
Blood Donation Study for ALPCO Syphilis-T and Syphilis-NT Assay Development
An observational study of Healthy Volunteers and Syphilis Serologic Assay Development, run by American Laboratory Products Company at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Syphilis Serologic Assay Development, Blood Specimen Collection
- What is being tested?
- ALPCO Syphilis-T and ALPCO Syphilis-NT CLIA Kits
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Male or female adults aged 22 years or older
- Able and willing to provide written informed consent
- Able and willing to provide a blood sample in accordance with the protocol
Who cannot join
- Unable or unwilling to provide written informed consent
- Unable or unwilling to undergo venipuncture
- Any medical condition that would make blood collection unsafe, as determined by study personnel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ALPCO Syphilis-T (Treponema Pallidum) CLIA Kit and ALPCO Syphilis-NT (Non-Treponemal Lipoidal Antigen) CLIA Kit Blood Donation Protocol
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers, Syphilis Serologic Assay Development, Blood Specimen Collection, Diagnostic Assay Development, Serum Specimen Collection
- Being tested
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Keywords
- Treponema pallidum, Syphilis-T, Syphilis-NT, Treponemal antibodies, Non-treponemal antibodies, Syphilis serology, Chemiluminescent immunoassay, Human serum matrix, Diagnostic assay development, Rapid plasma reagin, RPR, KleeYa Instrument, Blood donation, Serum collection
- Medical subject headings
- Treponemal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPCO Syphilis-TDevice
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.
ALPCO Syphilis-NT CLIA KitsDevice
Detection of antibodies to lipoidal antigens in human serum and plasma
| Study group | Role | What they receive |
|---|---|---|
| Adult Volunteer Blood Donors | Adult volunteers aged 22 years or older who provide one blood sample for serum collection and research use. 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.
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.
Measured: Day 1, following the single study visit and serum processing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startOct 2026 (estimated)
- 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 Healthy VolunteersStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT07830550
- Sponsor's protocol ID
- VPP-2026-079
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPCO Syphilis-T (Treponema Pallidum) CLIA Kit and ALPCO Syphilis-NT (Non-Treponemal Lipoidal Antigen) CLIA Kit Blood Donation Protocol
- ClinicalTrials.gov ID
- NCT07830550
- Acronym / sponsor ID
- VPP-2026-079
- Conditions
- Healthy Volunteers, Syphilis Serologic Assay Development, Blood Specimen Collection, Diagnostic Assay Development, Serum Specimen Collection
- Keywords
- Treponema pallidum, Syphilis-T, Syphilis-NT, Treponemal antibodies, Non-treponemal antibodies, Syphilis serology, Chemiluminescent immunoassay, Human serum matrix
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- American Laboratory Products CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2026 (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 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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Volunteer Blood Donors | – | Device: ALPCO Syphilis-T, Device: ALPCO Syphilis-NT CLIA KitsAdult volunteers aged 22 years or older who provide one blood sample for serum collection and research use. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Male or female adults aged 22 years or older
- Able and willing to provide written informed consent
- Able and willing to provide a blood sample in accordance with the protocol
Key exclusion criteria (3 listed)
- Unable or unwilling to provide written informed consent
- Unable or unwilling to undergo venipuncture
- Any medical condition that would make blood collection unsafe, as determined by study personnel
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-TApproximately 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. | Device | Adult Volunteer Blood Donors |
| ALPCO Syphilis-NT CLIA KitsDetection of antibodies to lipoidal antigens in human serum and plasma | Device | Adult Volunteer Blood Donors |
Primary outcome
Number of Blood Specimens Successfully Processed Into Serum
Time frame: Day 1, following the single study visit and serum processing
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.
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 22 Sep 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Syphilis Serologic Assay Development, run by American Laboratory Products Company at 1 site 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 22 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Blood Specimens Successfully Processed Into Serum (time frame: Day 1, following the single study visit and serum processing). 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 22 Sep 2026.