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| Name | Class |
|---|---|
| Public Health Agency of Canada (PHAC) | OTHER_GOV |
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This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).
This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).
The healthcare professional will advise patients about the study, and with their permission refer them to research staff for recruitment. Should patients choose to participate in the study they will be asked to provide consent to have a few drops of blood sample obtained through a finger prick to be used in the POCT. POCT results will not be provided to participants and this will be explained in both the recruitment script and informed consent form. A sample of 5 to 10 ml venous whole blood will also be obtained for the conventional syphilis serology testing which is part of the routine for care of the four categories of patients (regardless of this research). This research will take approximately 15 to 30 minutes and will be on top of the regular care that patients will receive in the clinic. Upon completing the tests, participants will be asked to complete a brief feedback survey to assess patients' acceptability of syphilis POCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test | Experimental | Participants are tested with investigational devices and conventional syphilis serology tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reveal TP (Syphilis) Antibody Test | Device | All subjects tested with both investigational devices and conventional syphilis serology tests. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the accuracy of Reveal TP (Syphilis) Antibody Test | For each enrolled subject, Reveal TP (Syphilis) 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 approximately 30 minutes |
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Inclusion Criteria:
Adult patients 19 years of age and above attending the BCCDC STI Clinic in Vancouver, British Columbia for routine sexual health care and requiring syphilis testing as part of this care are eligible for this study.
Additionally, for each participant category:
Those who had other STIs in the past or being suspected of having other STIs are not excluded as long as testing for syphilis is part of the care provided to them. Once it has been determined that the exclusion criteria does not apply to a patient, the recruitment of the four categories of participants will be offered without other pre-selection criteria unless there may be other unforeseeable circumstances arising, such as shortage of clinic staff or large number of patients showing up.
Exclusion Criteria:
• Minors, and those who, at the discretion of the health care provider/research co-ordinator, appear intoxicated and/or with extreme distress, or confused, will be excluded from this research because they would not be able to provide informed consent to participate.
Additionally, for each participant category:
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| Name | Affiliation | Role |
|---|---|---|
| Troy Grennan, Dr | British Columbia Center for Disease Control (BCCDC) | Principal Investigator |
| Raymond Tsang, Dr | National Microbiology Laboratory Branch, Public Health Agency of Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BCCDC STI Clinic | Vancouver | British Columbia | V5Z 4R4 | Canada |
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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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The result of the Reveal TP (Syphilis) Antibody Test will not be revealed to the participant.
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|
| 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 |