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

600 Participants Needed

Trial Summary

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 data supports the effectiveness of the Multiplo Complete Syphilis (TP/nTP) Antibody Test treatment?

The Multiplo Complete Syphilis (TP/nTP) Antibody Test is similar to other treponemal tests like the TPHA and FTA-ABS, which have been shown to be highly specific and sensitive for diagnosing syphilis. These tests are effective in confirming syphilis and monitoring treatment response, making them reliable for syphilis diagnosis. ^{1 2 3 4 5}

Is the Antibody Test for Syphilis safe for humans?

The research articles focus on the effectiveness and diagnostic performance of various syphilis antibody tests, but they do not provide specific safety data for humans. ^{1 6 7 8 9}

How does the Multiplo Complete Syphilis (TP/nTP) Antibody Test differ from other syphilis treatments?

The Multiplo Complete Syphilis (TP/nTP) Antibody Test is unique because it is designed to detect both treponemal and non-treponemal antibodies in a single test, potentially simplifying the diagnostic process compared to traditional methods that require separate tests for each type of antibody. ^{1 3 4 10 11}

What is the purpose of this trial?

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 to perform the POCT at the clinic.

Research Team

Patrick O'Byrne, PhD

Principal Investigator

Sexual Health Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

[Evaluation of automated architect syphilis TP as a diagnostic laboratory screening test for syphilis]. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Clinical application of serological tests for syphilis. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Present-day serological diagnosis of syphilis: comparison of TPHA and FTA-ABS tests with classical flocculation and complement-fixation reaction (author's transl)]. [2015]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of the passive particle agglutination test in the serodiagnosis and follow-up of syphilis. [2006]

6. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of different confirmatory algorithms using seven treponemal tests on Architect Syphilis TP-positive/RPR-negative sera. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the Determine Syphilis TP assay for the detection of antibodies against Treponema pallidum for the serodiagnosis of syphilis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of a rapid one-step immunochromatographic test and two immunoenzymatic assays for the detection of anti-Treponema pallidum antibodies. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of 17 serological treponemal and nontreponemal assays for syphilis: A retrospective cohort study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of the fluorescent treponemal antibody absorption test for detection of antibodies (immunoglobulins G and M) to Treponema pallidum in serologic diagnosis of syphilis. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of FlaB1, FlaB2, FlaB3, and Tp0463 of Treponema pallidum for serodiagnosis of syphilis. [2019]