Antibody Test for Syphilis

Overseen By Kayla Turner

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: MedMira Laboratories Inc.

Disqualifiers: Intoxication, Extreme distress, Confusion, Under 16

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new test detects syphilis using just a finger-prick of blood at an urban STI clinic. The focus is on the Multiplo Complete Syphilis (TP/nTP) Antibody Test, which could simplify and speed up testing. Suitable participants include those needing syphilis testing as part of their care or follow-up visits after a syphilis diagnosis. Individuals who have had or are suspected of having other sexually transmitted infections can still participate if syphilis testing is part of their care plan. As an unphased trial, this study offers a unique opportunity to advance syphilis testing technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this antibody test is safe?

Research has shown that the Multiplo Complete Syphilis (TP/nTP) Antibody Test is as safe as other quick tests for syphilis. Although specific safety data for this test is unavailable, similar tests are usually well-tolerated. These tests detect syphilis antibodies, proteins the body makes to fight the infection, and are considered safe. The Multiplo test is unique because it checks for two types of antibodies simultaneously, allowing for a faster diagnosis. While the FDA has not approved it, the test has a CE mark in Europe, indicating it meets safety standards there, suggesting it is safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most syphilis tests rely on separate procedures to detect Treponema pallidum (TP) and non-Treponema pallidum (nTP) antibodies. However, the Multiplo Complete Syphilis (TP/nTP) Antibody Test is unique because it combines the detection of both types of antibodies in a single test. This streamlined approach could lead to faster and more efficient diagnosis, which is why researchers are excited about its potential to improve syphilis screening. By simplifying the testing process, this method could enhance early detection and treatment, ultimately reducing the spread of the disease.

What evidence suggests that the Multiplo Complete Syphilis Antibody Test is effective for syphilis?

Research shows that the Multiplo Complete Syphilis (TP/nTP) Antibody Test, used by participants in this trial, detects both treponemal (TP) and non-treponemal (nTP) syphilis antibodies. This capability allows it to identify signs of a current or past syphilis infection with just one test. Other studies have successfully used this test to diagnose syphilis in sexual health clinics. It requires only a small blood sample from a finger prick, making it quick and easy to perform. While traditional tests might still show a positive result even after successful treatment, the Multiplo test aims to provide a clearer picture by also detecting nTP antibodies, which are present in active infections. ^{1 3 4 5 6}

Who Is on the Research Team?

Patrick O'Byrne, PhD

Principal Investigator

Sexual Health Clinic

Are You a Good Fit for This Trial?

This clinical trial is for individuals visiting a sexual health clinic in Ottawa who may have syphilis. The study aims to include participants from this specific urban population without any further specified inclusion or exclusion criteria provided.

Inclusion Criteria

I am following up at the clinic after being diagnosed with syphilis.

Able to provide consent

Patients Requiring Syphilis testing as part of care plan

Exclusion Criteria

I am able to understand and consent to my treatment.

I am under 16 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants are tested with the Multiplo Complete Syphilis (TP/nTP) Antibody Test and conventional syphilis serology tests

12 months

1 visit (in-person)

Survey and Evaluation

Participants and healthcare providers complete surveys on the acceptability and feasibility of the POCT

12 months

Follow-up

Participants are monitored for any additional feedback or outcomes post-testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multiplo Complete Syphilis (TP/nTP) Antibody Test

Trial Overview The trial is evaluating the Multiplo Complete Syphilis (TP/nTP) Antibody Test, which uses a finger-prick blood sample to quickly diagnose syphilis at the point of care within the clinic setting.

How Is the Trial Designed?

Group I: Experimental Diagnostic: Multiplo Complete Syphilis (TP/nTP) Antibody Test Experimental Treatment 1 Intervention

Subjects are tested with investigational devices and conventional syphilis serology tests.

Who Is Running the Clinical Trial?

MedMira Laboratories Inc.

Lead Sponsor

Trials

5

Recruited

3,800+

Published Research Related to This Trial

The Architect Syphilis TP (AST) test demonstrated a significantly higher positive rate compared to the RPR test in preoperative and other disease groups, indicating its potential as a more effective screening tool for syphilis.

The AST showed high concordance rates of 97.4% with RPR and 97.5% with TPHA, suggesting it is a reliable method for detecting syphilis, including latent infections, when used in a new testing algorithm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of automated architect syphilis TP as a diagnostic laboratory screening test for syphilis]. Kim, J., Kim, WH., Cho, C., et al.[2019]

The study evaluated eight treponemal assays for syphilis diagnosis using 290 serum samples, finding that all assays showed high concordance with the TP-PA test, indicating their reliability for confirming syphilis infection.

While the treponemal assays performed comparably with medium and high-titre sera, differences in sensitivity were noted with low-titre sera, which could affect diagnosis in early or late stages of syphilis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the analytical level of agreement of nine treponemal assays for syphilis and possible implications for screening algorithms. Jost, H., Castro, A., Cox, D., et al.[2021]

The study involving 449 patients with early syphilis found that the TP.PA test showed a very high concordance rate of 98.4% with the MHA-TP test and 98.9% with the FTA-ABS test, indicating its reliability for diagnosing syphilis.

After treatment, the TP.PA test demonstrated a significant decrease in antibody levels in 70% of patients, suggesting it is effective for monitoring therapy, similar to the RPR test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the passive particle agglutination test in the serodiagnosis and follow-up of syphilis. Castro, RR., Prieto, ES., Santo, I., et al.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06586905?term=AREA%5BBasicSearch%5D(medmira)&rank=1

NCT06586905 | A Cross-sectional Investigational Study to ... Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario.

2. finance.yahoo.com finance.yahoo.com/news/medmira-receives-investigational-testing-authorization-230000494.html

MedMira Receives Investigational Testing Authorization for ... The Multiplo® TP/nTP test detects both treponemal (TP) and non-treponemal (nTP) syphilis antibodies in a single diagnostic tool that targets ...

3. withpower.com withpower.com/trial/phase-treponemal-infections-5-2024-1b238

Antibody Test for Syphilis · Info for Participants This study is to test the Multiplo Complete Syphilis (TP/nTP) Antibody Test for its performance in an urban STI clinic using finger-prick obtained whole blood ...

4. medmira.ca medmira.ca/post/clinical-trials-to-get-underway-with-multiplo-complete-syphilis-tp-ntp-antibody-test-a-potentia

Clinical Trials to get Underway with Multiplo® Complete ... The Multiplo® TP/nTP test integrates the detection of both treponemal (TP) and non-treponemal (nTP) antibodies into a single diagnostic tool.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK602665/

Rapid Syphilis Testing - NCBI Bookshelf - NIH Treponemal tests will typically show a positive result for life once a person has had syphilis, regardless of treatment, which can lead to false-positive test ...

6. withpower.com withpower.com/trial/phase-syphilis-7-2024-414d6

Rapid Test for Syphilis · Info for Participants The research does not provide specific safety data for the Rapid Test for Syphilis, but similar tests for detecting syphilis antibodies have shown high ...