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| Name | Class |
|---|---|
| Public Health Agency of Canada (PHAC) | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiplo Complete Syphilis (TP/nTP) Antibody Test | Experimental | Participants are tested with investigational devices and conventional syphilis serology tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Device | Device | Multiplo Complete Syphilis (TP/nTP) Antibody Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the accuracy of Multiplo Complete Syphilis (TP/nTP) Antibody Test | For each enrolled subject, Multiplo Complete Syphilis (TP/nTP) Antibody Test will be used to test fingerstick whole blood from the patient. A venipuncture whole blood sample will also be drawn from the patient and will be tested using conventional serological testing methods to determine patient status. | 1 patient visit of appoximately 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer MacLellan | Contact | 902-450-1588 | support@medmira.com | |
| Kayla Turner | Contact | 902-450-1588 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sexual Health Clinic | Recruiting | Ottawa | Ontario | K1N 1B3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41361278 | Derived | O'Byrne P, Dillabough R, Whyte K, Orser L, Tran V, Duvvuri VR, Tsang R. Evaluating the MedMira Multiplo(R) Complete Syphilis (TP/nTP) antibody test in a sexually transmitted infection clinic in Ottawa, Canada: increased rapid diagnosis and improved antibiotic stewardship. BMC Infect Dis. 2025 Dec 8;26(1):48. doi: 10.1186/s12879-025-12263-w. |
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| ID | Term |
|---|---|
| D013587 | Syphilis |
| D014211 | Treponemal Infections |
| ID | Term |
|---|---|
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| 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 |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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