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New syphilis test kits put to the test with donated blood

NCT ID NCT07830550

NEW Diagnosis Sponsor: American Laboratory Products Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are collecting blood from about 50 healthy adults aged 22 and older to help develop two new laboratory test kits for syphilis antibodies. Each participant gives one blood sample of roughly 20 to 50 milliliters during a single visit. The serum from these samples is used to build and check the performance of the ALPCO Syphilis-T and Syphilis-NT assays. All testing is for research only, and participants do not receive individual results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood collection for developing two syphilis antibody test kits
What this could lead to
If the kits perform well, they could give labs another way to screen blood and serum for syphilis antibodies.
What could go wrong
This is an early laboratory study with about 50 volunteers. The kits may not work as hoped, and the samples come from healthy adults, so they may not reflect real-world infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 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 Exclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

Treponema infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood specimen collection Diagnostic assay development Healthy volunteers Serum specimen collection Syphilis serologic assay development

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ALPCO

    Salem, New Hampshire, 03079, United States

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