Rapid Test for Syphilis

Overseen By Kayla Turner

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: MedMira Laboratories Inc.

Disqualifiers: Intoxication, Extreme distress, Under 16

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

1300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new rapid test for syphilis compared to standard lab tests. This is crucial as syphilis cases are rising in Canada, particularly among women of childbearing age, leading to serious issues like congenital syphilis. The new test, MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test, a point-of-care test, could enable health workers to quickly identify and treat those at risk. Individuals visiting a sexual health clinic for syphilis testing and able to provide consent might be suitable for this trial. As an unphased trial, this study offers participants the opportunity to contribute to significant public health research that could lead to faster syphilis diagnosis and treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing for syphilis, so it's best to ask the trial coordinators for more details.

What prior data suggests that this test is safe?

Research has shown that the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test is safe to use. Health Canada has approved this test for detecting syphilis antibodies, confirming it meets safety standards for humans. The test requires a small blood sample from a finger prick and delivers quick results. Studies have not reported any serious side effects or safety concerns with this test. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test because it offers a rapid point-of-care testing option for syphilis. Unlike traditional serology tests, which can take days to yield results, this test provides results quickly, allowing for faster diagnosis and treatment decisions. This speed can significantly improve patient outcomes by reducing the time between testing and treatment. Additionally, the test is designed to simultaneously detect both Treponemal and non-Treponemal antibodies, potentially increasing its accuracy compared to standard tests that often require multiple steps and separate testing for confirmation.

What evidence suggests that this rapid test is effective for detecting syphilis?

Research has shown that the MedMira Inc. Multiplo® Complete Syphilis Antibody Test, used by participants in this trial, can detect two types of syphilis antibodies in one test. Identifying these antibodies is crucial for accurately diagnosing syphilis. This test combines both screening and confirmation in a single step, making the testing process faster and easier. Some studies suggest that this quick test can provide results using just a finger-prick blood sample. Designed for use at the point of care, it could help diagnose syphilis quickly and efficiently, especially in high-risk groups. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals visiting the Sexual Health Clinic in Ottawa who may be at risk of syphilis. There are no specific inclusion or exclusion criteria provided, suggesting it might be open to a broad range of participants typically seen at such clinics.

Inclusion Criteria

I am joining the trial without any specific pre-selection criteria.

I am 16 or older, need a syphilis test, and can consent to participate.

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

Exclusion Criteria

Patients who, at the discretion of the HCPs/research co-ordinator, appear intoxicated and/or with extreme distress, or confused

I am under 16 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

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

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for any adverse reactions and the accuracy of the test results is evaluated

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT)

Trial Overview The study is evaluating the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test, a rapid point-of-care test designed to diagnose infectious syphilis quickly and on-site, comparing its accuracy with conventional lab-based testing methods.

How Is the Trial Designed?

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

Participants 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+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Published Research Related to This Trial

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]

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 BioPlex 2200 Syphilis Total Screen, which detects both IgG and IgM antibodies, demonstrated high sensitivity (95.6%) and specificity (99.6%) when paired with an automated RPR assay, making it a reliable option for syphilis screening.

The new automated RPR assay showed comparable performance to the traditional RPR, with a sensitivity of 95.8% and specificity of 94.1%, while significantly reducing the labor involved in syphilis screening and confirmation processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the BioPlex 2200 syphilis total screen (IgG/IgM) with reflex to an automated rapid plasma reagin test. Rourk, AR., Litwin, CM.[2021]

The MedMira Multiplo Rapid TP/HIV Antibody Test demonstrated high sensitivity (93.8%) and perfect specificity (100%) for detecting HIV antibodies, indicating it is a reliable tool for HIV screening.

For syphilis detection, the test showed good sensitivity (81.0%) and perfect specificity (100%), suggesting it can effectively integrate syphilis screening into existing HIV prevention programs, potentially increasing overall testing rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field Evaluation of a Dual Rapid Immunodiagnostic Test for HIV and Syphilis Infection in Peru. Bristow, CC., Leon, SR., Huang, E., et al.[2018]

The automated latex agglutination test for Treponema pallidum (TPLA) effectively measures treponemal antibodies in syphilitic sera without requiring complex sample preparation, making it user-friendly for clinical settings.

This test demonstrated high reproducibility and was not affected by common interfering substances, showing strong correlation with conventional testing methods, suggesting its potential for mass screening of syphilis infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latex agglutination test for detecting antibodies to Treponema pallidum. Matsumoto, M., Ishikawa, F., Matsubayashi, T., et al.[2019]

The dual point-of-care syphilis test demonstrated high sensitivity (96.7% for whole blood, 96.4% for fingerprick blood, and 94.6% for blood plasma) and specificity (99.3% for whole blood, 99.1% for fingerprick blood, and 99.6% for blood plasma) when compared to the Treponema pallidum particle agglutination (TPPA) assay, indicating its effectiveness in accurately diagnosing syphilis.

This test is particularly promising for use in resource-limited settings, as it can utilize various specimen types and still maintain high diagnostic performance, making syphilis screening and treatment more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dual point-of-care test shows good performance in simultaneously detecting nontreponemal and treponemal antibodies in patients with syphilis: a multisite evaluation study in China. Yin, YP., Chen, XS., Wei, WH., et al.[2021]

In a study of 73 patients, the Auto3 TP test demonstrated greater sensitivity than the TPPA test for detecting syphilis at low antibody titers, making it a promising option for screening primary infections.

While the Auto3 TP test is adaptable to various automated analyzers, it did not show significant superiority over the Architect Syphilis TP assay at low antibody levels, indicating that both tests are viable for syphilis screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical significance comparison of a latex agglutination based syphilis screening test at low antibody titer. Wang, HC., Chen, C., Wang, LN., et al.[2022]

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]

Citations

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

NCT06586905 | A Cross-sectional Investigational Study to ... This study is designed to test the performance of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) ( MedMira Inc., Halifax, Nova ...

2. 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 new Multiplo® TP/nTP will provide a complete system which combines screening and confirmation in one test.

3. 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 ...

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

Rapid Test for Syphilis · Info for Participants This study is designed to test the performance of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) (MedMira Inc., Halifax, Nova Scotia) ...

5. biospace.com biospace.com/press-releases/health-canada-approves-medmiras-revealr-rapid-tp-test-urgent-new-tool-in-the-battle-against-syphilis

Health Canada Approves MedMira's Reveal(R) Rapid TP ... The test detects syphilis antibodies from a single finger-prick blood sample, delivering results immediately that do not fade away. It is the ...

6. reachnexus.ca reachnexus.ca/newsroom/health-canada-approves-medmiras-reveal-rapid-tp-test---urgent-new-tool-in-the-battle-against-syphilis

Health Canada Approves MedMira's Reveal Rapid TP Test The test detects syphilis antibodies from a single finger-prick blood sample, delivering results immediately that do not fade away. It is the ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06586905/a-cross-sectional-investigational-study-to-evaluate-the-sensitivity-specificity-and-utility-of-the-medmira-inc-multiplor-complete-syphilis-tp-ntp-antibody-test-poct-to-diagnose-infectious-syphilis-in-participants-attending-the-sexual-health-clinic-in-ottawa-ontario

A Cross-sectional Investigational Study to Evaluate the ... This study is designed to test the performance of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) (MedMira Inc ...