Rapid Test for Syphilis

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: MedMira Laboratories Inc.

Disqualifiers: Intoxication, Extreme distress, Under 16

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of congenital syphilis cases and stillbirths, the demand of a rapid test such as POCT that can be used at the place and time that front-line public health workers meet the at risk population is getting louder. Indeed during a number of federal, provincial and territorial meetings on the control of syphilis outbreaks in Canada, requests for POCT to detect syphilis infections have repeatedly come up. However, before a POCT can be widely used, research to find out if it is accurate and reliable is necessary. 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) in an urban clinic (Sexual Health Clinic) in Ottawa, Ontario, Canada and compare its performance in parallel with the usual testing method (the gold standard, i.e. conventional syphilis serology testing).

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 data supports the effectiveness of the treatment MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) for syphilis?

The MedMira Multiplo Rapid TP/HIV Antibody Test, which is similar to the Multiplo® Complete Syphilis Test, has been shown to effectively detect antibodies for both syphilis and HIV, allowing for integrated screening and potentially increasing the number of people tested and treated on the same day. ^{1 2 3 4 5}

Is the Rapid Test for Syphilis safe for humans?

The research does not provide specific safety data for the Rapid Test for Syphilis, but similar tests for detecting syphilis antibodies have shown high reproducibility and were not affected by potentially interfering substances, suggesting they are generally safe for use in humans. ^{1 3 4 6 7}

How does the rapid test for syphilis differ from other treatments?

The rapid test for syphilis is unique because it allows for the simultaneous detection of syphilis and HIV antibodies using a single specimen, enabling same-day testing and treatment. This integrated approach can increase the number of people tested and streamline the process compared to traditional methods that test for each infection separately. ^{1 3 4 7 8}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Germany pubmed.ncbi.nlm.nih.gov

The clinical significance comparison of a latex agglutination based syphilis screening test at low antibody titer. [2022]

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

Field Evaluation of a Dual Rapid Immunodiagnostic Test for HIV and Syphilis Infection in Peru. [2018]

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

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

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Latex agglutination test for detecting antibodies to Treponema pallidum. [2019]

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

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

8. United States 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. [2021]