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| Name | Class |
|---|---|
| Public Health Agency of Canada (PHAC) | OTHER_GOV |
| Chembio Diagnostic Systems, Inc. | INDUSTRY |
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The goal of this observational study is to evaluate the sensitivity, specificity, and utility of the DPP® Syphilis Screen & Confirm antibody point-of-care test (POCT) to diagnose infectious syphilis in participants attending the Nine Circles Community Health Centre in Winnipeg, Manitoba.
The main questions are: Does the POCT provide accurate results compared to conventional syphilis serology methods? and Can the use of POCT improve the timeline for diagnosis and treatment of syphilis?
Researchers will compare the POCT results with conventional laboratory testing to assess if the rapid test can reliably diagnose syphilis during the initial clinic visit.
Participants will: Provide a blood sample via fingerstick for POCT testing and complete a feedback survey to evaluate the POCT experience.
Key details: This study will involve approximately 600 participants aged 18 and older over the course of 12 months which includes both new and repeat visits
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| point of care test | Device | DPP Syphilis Screen and Confirm antibody point-of-care-test (POCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Point of Care Test Performance | Sensitivity of POCT: Percentage of participants with laboratory-confirmed active syphilis who are identified as positive by the POCT, Specificity of POCT: Percentage of participants without laboratory-confirmed active syphilis who are identified as negative by the POCT | From start of enrollment to the end of the enrollment period (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary POCT Performance Measures | False Positive Rate: Percentage of participants without active syphilis who test positive by POCT for active syphilis. False Negative Rate: Percentage of participants with active syphilis who test negative by POCT for active syphilis. | From start of enrollment to the end of the enrollment period (12 months) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population for this research comprises individuals seeking care at the Nine Circles Community Health Centre in Winnipeg, Manitoba, Canada. Participants are adults (aged 18 years or older) attending the clinic for routine sexual health care, which includes syphilis testing as part of their standard care. The clinic caters to a diverse urban population which is comprised of newcomers to Canada, indigenous, and LGBTQ2S+ community and receives a significant number of syphilis serology specimens annually, reflecting a broad spectrum of individuals who may present with varying sexual health needs. This setting provides a unique opportunity to evaluate the performance of the DPP® Syphilis Screen & Confirm antibody point-of-care test in a real-world clinical environment
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nine Circles Community Health Centre | Winnipeg | Manitoba | R3G 0X2 | Canada |
Data and information will not be shared outside agencies for safety and privacy of the participants. Performance of POCT will be evaluated by the research team and the findings may be used for publication; however, any published or disseminated results will omit information that could potentially identify participants (name, date of birth, address and provincial health identifier number).
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| ID | Term |
|---|---|
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| Comparison of Results by POCT Methodology | Comparison of visual vs micro-reader assisted results | From start of enrollment to the end of the enrollment period (12 months) |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |